Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported first quarter
2024 financial results and recent portfolio and business updates.
As of March 31, 2024, Alector’s cash, cash equivalents and
investments totaled $562.1 million.
“Continuing the momentum built through the first quarter,
Alector is well positioned to have an impactful year, supported by
an extended cash runway that carries the company through 2026,”
said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector.
“We are advancing our maturing pipeline, including our pivotal
Phase 3 trial of latozinemab in FTD-GRN. In early Alzheimer’s
disease, we are now investigating two clinical candidates. The data
readout from the INVOKE-2 Phase 2 clinical trial of AL002 is
expected in the fourth quarter, while enrollment continues in the
PROGRESS-AD Phase 2 trial of AL101/GSK4527226. Additionally, the
potential of our versatile blood-brain barrier technology, Alector
Brain Carrier, to enhance brain penetrance of selected product
candidates is exciting and provides opportunities to further expand
our clinical pipeline for the long term. With the most advanced
TREM2-activating and PGRN-modulating product candidates in clinical
trials and a robust early-stage pipeline, we remain dedicated to
developing medicines for individuals suffering from brain
disorders.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and
Development at Alector, added, “In addition to these encouraging
research and development updates, Alector continues to strengthen
its leadership team with executive and Board appointments. We are
excited to recognize the addition of Neil Berkley to our executive
team as our Chief Business Officer. Neil has over 20 years of
corporate development, business development and strategic planning
experience, spanning large pharma to small biotechs. Additionally,
we are pleased to welcome Dr. Errol De Souza and Mark Altmeyer to
our Board of Directors. As our late-stage clinical assets progress
closer toward potential FDA approval and commercialization, we look
forward to leveraging their collective experience.”
Recent Clinical Updates
Immuno-Neurology
PortfolioProgranulin Programs (latozinemab (AL001)
and AL101/GSK4527226) Being Developed in Collaboration with
GSK
- The pivotal, randomized,
double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial
of latozinemab in frontotemporal dementia with a progranulin gene
mutation (FTD-GRN) is ongoing after reaching full enrollment in
October 2023. The trial has a treatment duration of 96 weeks.
- Enrollment is ongoing in the PROGRESS-AD global Phase 2
clinical trial of AL101/GSK4527226 in early Alzheimer’s disease
(AD), with dosing initiated in February 2024. AL101 is an
investigational human monoclonal antibody (mAb) designed to block
and downregulate the sortilin receptor to elevate the level of
progranulin (PGRN) in the brain in a manner that is similar to
latozinemab but with different pharmacokinetic (PK) and
pharmacodynamic (PD) properties. Alector and GSK are co-developing
AL101 for the potential treatment of more prevalent
neurodegenerative diseases, including AD and Parkinson’s
disease.
- Alector and GSK plan to present a poster on the design of the
AL101 Phase 2 trial at the Alzheimer's Association International
Conference® 2024 (AAIC®) in Philadelphia from July 28 to August 1,
2024. The poster is entitled, “PROGRESS-AD: a Phase 2 study to
evaluate efficacy and safety of GSK4527226 (AL101), an
anti-sortilin monoclonal antibody, in patients with early
Alzheimer's disease.”
TREM2 Program (AL002) Being Developed in
Collaboration with AbbVie
- The INVOKE-2 Phase 2 clinical trial of AL002 is fully enrolled,
and data from the trial are anticipated in the fourth quarter of
2024. INVOKE-2, a randomized, double-blind, placebo-controlled,
dose-ranging study, is designed to evaluate the efficacy and safety
of AL002 in slowing disease progression in individuals with early
AD. AL002 is a novel investigational humanized mAb that binds to
TREM2 to increase TREM2 signaling and, thereby, is hypothesized to
improve the functionality of microglia. It is the most advanced
TREM2-activating product candidate in clinical development
worldwide.
- The company expects to report baseline characteristics data
from the Phase 2 trial of AL002 at a medical conference later this
year, providing insights into the early AD patient population
enrolled, including key baseline health metrics and disease
characteristics.
- AbbVie has an exclusive option to
globally develop and commercialize AL002. AbbVie’s exercise of that
option would prompt a $250 million payment to Alector.
Early Research Pipeline
- Alector continues to advance Alector Brain Carrier (ABC), a
proprietary, versatile blood-brain barrier (BBB) technology
platform, which is being applied selectively to the company’s
next-generation product candidates and research pipeline.
- Alector will host a virtual research and development event on
June 18, 2024, to discuss the company’s ABC technology platform.
The event will include a presentation from a leading scientific
expert, offering insights into emerging technologies for BBB
modulation and discussing future directions and opportunities in
the field. The event will be webcast live on the Investor section
of the company’s website at https://investors.alector.com.
- Details of the
event are as follows:Crossing the Blood-Brain Barrier:
Advancing the Next Generation of Alector Neurodegenerative
Therapies
- June 18, 2024,
at 12 pm Pacific Daylight Time / 3 pm Eastern Daylight Time
Corporate
- In March 2024, Alector expanded its executive leadership team
with the appointment of Neil Berkley, M.S., M.B.A., as Chief
Business Officer. Mr. Berkley is responsible for driving strategic
growth and maximizing partnership opportunities at the company. He
brings over 20 years of extensive experience in corporate
development, business development and strategic planning across a
spectrum of biopharmaceutical companies.
- In March 2024, Alector strengthened
its Board of Directors with the appointments of Errol De Souza,
Ph.D., and Mark Altmeyer, M.B.A.
- Dr. De Souza is an esteemed leader
in research and development, as well as a seasoned business
executive, whose expertise is focused on the discovery and
development of therapeutics targeting central nervous system (CNS)
disorders.
- Mr. Altmeyer has more than 35 years
of experience leading successful drug development and
commercialization efforts as a biopharmaceutical executive, with a
focus on CNS disorders and oncology.
First Quarter 2024 Financial
Results
Revenue. Collaboration revenue
for the quarter ended March 31, 2024, was $15.9 million, compared
to $16.5 million for the same period in 2023. The decrease was
primarily due to a decrease in collaboration revenue recognized for
the AL001 program.
R&D Expenses. Total
research and development expenses for the quarter ended March 31,
2024, were $45.2 million, compared to $51.9 million for the quarter
ended March 31, 2023. The decrease was mainly driven by the
Company’s prioritization on selected late-stage programs and a
decrease in personnel-related costs.
G&A Expenses. Total general
and administrative expenses for the quarter ended March 31, 2024,
were $14.4 million, compared to $14.8 million for the quarter ended
March 31, 2023.
Net Loss. For the quarter ended
March 31, 2024, Alector reported a net loss of $36.1 million, or
$0.38 per share, compared to a net loss of $45.9 million, or $0.55
net loss per share, for the same period in 2023.
Cash Position. Cash, cash
equivalents, and investments were $562.1 million as of March 31,
2024. In January 2024, Alector further strengthened its
balance sheet with the completion of a follow-on financing issuing
10,869,566 shares of its common stock for total gross proceeds
of $75 million before deducting underwriting discounts
and commissions and estimated offering expenses. Management expects
that this will be sufficient to fund current operations through
2026.
2024 Guidance. Management is
reiterating its guidance for the year ending 2024. The company
continues to anticipate collaboration revenue to be between $60
million and $70 million, total research and development expenses to
be between $210 million and $230 million, and total general and
administrative expenses to be between $60 million and $70
million.
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 rejuvenated immune cells to
counteract emerging brain pathologies. Alector’s immuno-neurology
product candidates are supported by biomarkers and seek to treat
indications, including Alzheimer’s disease and genetically defined
frontotemporal dementia patient populations. 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 and ongoing preclinical
studies and clinical trials, expected milestones, expectations of
our collaborations, expected benefits of Dr. De Souza’s and Mr.
Altmeyer’s appointment to our Board of Directors and Mr. Berkley’s
appointment as our Chief Business Officer, 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 filed on
May 8, 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) |
|
|
March 31, |
|
|
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
Cash, cash equivalents, and marketable securities |
$ |
562,083 |
|
|
$ |
548,861 |
|
Total assets |
|
635,494 |
|
|
|
621,827 |
|
Total current liabilities
(excluding deferred revenue) |
|
91,565 |
|
|
|
94,973 |
|
Deferred revenue (including
current portion) |
|
277,927 |
|
|
|
293,820 |
|
Total liabilities |
|
456,587 |
|
|
|
487,669 |
|
Total stockholders’
equity |
|
178,907 |
|
|
|
134,158 |
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data) |
|
|
|
Three Months EndedMarch 31, |
|
|
2024 |
|
|
2023 |
|
Collaboration revenue |
$ |
15,893 |
|
|
$ |
16,549 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
45,167 |
|
|
|
51,887 |
|
General and administrative |
|
14,434 |
|
|
|
14,777 |
|
Total operating expenses |
|
59,601 |
|
|
|
66,664 |
|
Loss from operations |
|
(43,708 |
) |
|
|
(50,115 |
) |
Other income, net |
|
7,636 |
|
|
|
5,159 |
|
Loss before income taxes |
|
(36,072 |
) |
|
|
(44,956 |
) |
Income tax expense |
|
7 |
|
|
|
901 |
|
Net loss |
$ |
(36,079 |
) |
|
$ |
(45,857 |
) |
Net loss per share, basic and
diluted |
$ |
(0.38 |
) |
|
$ |
(0.55 |
) |
Shares used in computing net
loss per share basic and diluted |
|
93,810,177 |
|
|
|
83,102,296 |
|
Alector Contacts:
AlectorKatie Hogan 202-549-0557katie.hogan@alector.com
1AB (media)Dan Budwick973-271-6085 dan@1abmedia.com
Argot Partners (investors)Laura Perry
212.600.1902alector@argotpartners.com
Alector (NASDAQ:ALEC)
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