Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported fourth quarter
and full year 2023 financial results and recent portfolio and
business updates. As of December 31, 2023, Alector’s cash, cash
equivalents and investments totaled $548.9 million. Pro forma for
Alector’s January 2024 equity offering, cash, cash equivalents and
investments total $620.0 million, which the company anticipates
will provide runway through 2026.
“2023 was marked by continued progress on the
execution of our late-stage clinical programs, highlighted by
achieving target enrollment in both the INVOKE-2 Phase 2 trial of
AL002 and the pivotal INFRONT-3 Phase 3 trial of latozinemab.
Additionally, the FDA granted Breakthrough Therapy Designation to
latozinemab for FTD-GRN, and we look forward to continued
productive engagements with the FDA, recognizing the unmet need for
people living with the condition. We are also pleased to report
that the first patient has been dosed in the PROGRESS-AD Phase 2
trial of AL101/GSK4527226,” said Arnon Rosenthal, Ph.D., Chief
Executive Officer of Alector. “Alector continues to be a pioneer in
the field of immuno-neurology, and we are beginning the year with
an advanced pipeline and an extended cash runway through 2026,
approximately a full year beyond the expected FTD-GRN pivotal Phase
3 INFRONT-3 data readout. Our unwavering commitment to addressing
neurodegeneration fuels progress across our clinical-stage
programs, with an anticipated data readout from the INVOKE-2 Phase
2 trial of AL002 in the fourth quarter of this year.”
Sara Kenkare-Mitra, Ph.D., President and Head of
Research and Development at Alector added, “We also made meaningful
strides in our Alector Brain Carrier platform, which is our
proprietary blood brain barrier technology. We intend to leverage
this platform technology selectively across our portfolio to
increase exposure to the central nervous system by enhancing
transport across the blood brain barrier. Moreover, we remain
committed to the development of our early programs with additional
targets in Alzheimer’s disease, amyotrophic lateral sclerosis, and
Parkinson’s disease, which could position us to further expand our
portfolio of transformative investigational therapies and achieve
our ambitious vision of making brain disorders history.”
Cash Runway Extension Through
2026
With $620.0 million in cash, cash equivalents
and investments pro forma for the January 2024 equity offering,
Alector has extended its cash runway through 2026, approximately a
full year beyond the expected data readout for the pivotal Phase 3
INFRONT-3 clinical trial of latozinemab in participants with
frontotemporal dementia due to a mutation in the progranulin gene
(FTD-GRN). The extended cash runway also allows the company to
selectively accelerate investment in its novel, first-in-class
proprietary portfolio.
Recent Clinical Updates
Immuno-Neurology
PortfolioProgranulin Programs (AL101/GSK4527226
and latozinemab (AL001)) Being Developed in Collaboration with
GSK
- In February 2024, GSK dosed the
first participant in the PROGRESS-AD global Phase 2 clinical trial
of AL101/GSK4527226 in early Alzheimer’s disease (AD), including
mild cognitive impairment and mild dementia due to AD. 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.
- In August 2023, GSK received U.S.
Food and Drug Administration (FDA) clearance of its Investigational
New Drug (IND) application for AL101 in the treatment of early AD.
Modest reduction in the levels of PGRN due to genetic mutations has
been shown to be associated with an increased risk of developing
AD. Conversely, an elevation of PGRN has been shown to be
protective in animal models of AD.
- In February 2024, the FDA granted
Breakthrough Therapy Designation to latozinemab for the treatment
of FTD-GRN. The FDA's Breakthrough Therapy Designation is granted
to expedite the development and review of drugs in the United
States that are intended to treat a serious condition when
preliminary clinical evidence indicates the drug may demonstrate
substantial improvement over available therapy on clinically
significant endpoint(s).1
- In October 2023, Alector achieved
target enrollment of 103 symptomatic and 16 at-risk participants
with FTD-GRN in the pivotal, randomized, double-blind,
placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab
for a treatment duration of 96 weeks. Target enrollment was
supported by feedback from the FDA and European Medicines
Agency.
- In November 2023, Alector published a manuscript in the
International Journal of Molecular Sciences titled, “Targeting
Progranulin as an Immuno-Neurology Therapeutic Approach.” The
publication discusses immuno-neurology as an emerging therapeutic
strategy for dementia and neurodegeneration designed to address
immune surveillance failure in the brain. Immuno-neurology is a
promising alternative and potentially complementary approach to
current neurodegenerative therapies that focus on removing singular
types of misfolded proteins from the central nervous system.
- In February 2024, Alector published a manuscript in Alzheimer’s
& Dementia®: Translational Research & Clinical
Interventions (TRCI) titled, “Phase 1 study of latozinemab in
progranulin-associated frontotemporal dementia.” The publication
outlines Phase 1b clinical trial results, demonstrating that
latozinemab was well tolerated, and a favorable PK/PD profile was
observed in eight symptomatic participants with FTD-GRN.
Additionally, multiple-dose administration of latozinemab increased
plasma and cerebrospinal fluid (CSF) PGRN levels in participants
with FTD-GRN to levels approximating those seen in healthy
volunteers.
TREM2 Program (AL002) Being Developed in
Collaboration with AbbVie
- In September 2023, Alector
completed enrollment of 381 participants in the randomized,
double-blind, placebo-controlled, dose-ranging, INVOKE-2 Phase 2
clinical trial. To date, more than 90 percent of eligible
participants who completed the planned treatment period of INVOKE-2
have rolled over into the long-term extension portion of the trial.
INVOKE-2 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.
Data from the trial is anticipated in the fourth quarter of 2024.
- INVOKE-2 utilizes a common close
design with up to 96 weeks of randomized treatment, and all
participants remain on their assigned regimen until the last
participant completes 48 weeks of treatment. This design provides
the opportunity to capture more observations for the primary
analysis. The primary endpoint is disease progression as measured
by the Clinical Dementia Rating Sum of Boxes (CDR®-SB). The
CDR®-SB, which is used to assess (score) the severity of AD, is a
validated instrument that assesses both cognitive and functional
domains and is the FDA-accepted efficacy endpoint. The trial also
employs multiple other clinical and functional outcome assessments,
including CSF and plasma biomarkers, brain magnetic resonance
imaging (MRI) and amyloid beta and tau positron emission tomography
(PET) imaging to assess treatment effects on microglial signaling
and Alzheimer’s pathophysiology.
- In July 2023, Alector presented an
update on INVOKE-2 at the Alzheimer’s Association International
Conference (AAIC). The presentation highlighted that
treatment-emergent MRI findings resembling amyloid-related imaging
abnormalities (ARIA) in INVOKE-2 are similar to the ARIA reported
following treatment with anti-amyloid beta antibodies.
- Alector previously presented
results from a Phase 1 trial of AL002 in healthy volunteers, which
demonstrated both dose-dependent target engagement and activation
of microglia. In the trial, AL002 was also shown to be well
tolerated.
- Microglial activation is
hypothesized to not only enhance clearance of misfolded proteins
that accumulate and form amyloid plaques but also perform other
supportive microglia functions, including maintenance of neuronal
and synaptic health.
- Alector received a $17.8 million
milestone payment from AbbVie in March 2023 after enrolling and
dosing the first participants in a long-term extension (LTE) of the
INVOKE-2 Phase 2 clinical trial in participants with early AD.
Additionally, in 2023, Alector received payments totaling $12.5
million from AbbVie to support enrollment in the INVOKE-2
trial.
Early Research Pipeline
- Alector continues to develop its
Alector Brain Carrier (ABC), a proprietary, versatile blood-brain
barrier technology, which is being applied to selectively enhance
its next-generation product candidates.
- The company is strategically
advancing its innovative research portfolio, including the
development of ADP027-ABC. The ADP027-ABC program incorporates ABC
technology to enhance brain penetrance and targets modulation of
the glycoprotein GPNMB for the treatment of Parkinson’s
disease.
Corporate
- In December 2023, Alector hosted
two virtual research and development events discussing the
company’s TREM2 and PGRN programs in detail. The events included
presentations from leading scientific and clinical experts who
provided their perspectives on the biological and genetic rationale
for the TREM2 and PGRN targets, shared an overview of the current
FTD and AD treatment landscapes, and discussed the significant
unmet need that remains in the treatment of these neurodegenerative
diseases.
- In the second
quarter of 2023, the U.S. Patent and Trademark Office issued a
patent covering methods of treatment using AL002. The European
Patent Office also issued a patent in the second quarter of 2023
covering AL002 compositions and methods of use.
Fourth Quarter 2023 Financial
Results
Revenue. Collaboration revenue
for the quarter ended December 31, 2023, was $15.2 million,
compared to $14.4 million for the same period in 2022.
Collaboration revenue for the year ended December 31, 2023, was
$97.1 million, compared to $133.6 million for the same period in
2022. The decrease in year-over-year collaborative revenue was
primarily due to revenue recognized from the termination of the
AL003 program in 2022, offset by higher revenue recognized for the
AL101 programs, including a non-cash revenue adjustment due to
contract modification to have GSK operationalize the AL101 Phase 2
study and higher revenue recognized for the AL002 program due to
the addition of AL002 LTE and patient replacement revenue in
2023.
R&D Expenses. Total
research and development expenses for the quarter ended December
31, 2023, were $47.7 million, compared to $54.5 million for the
quarter ended December 31, 2022. Total research and development
expenses for the year ended December 31, 2023, were $192.1 million
compared to $210.4 million for the same period in 2022. The
decrease in year-over-year R&D expenses was mainly driven by
the Company’s strategy to prioritize late-stage programs.
G&A Expenses. Total general
and administrative expenses for the quarter ended December 31,
2023, were $14.9 million, compared to $15.4 million for the quarter
ended December 31, 2022. Total general and administrative expenses
for the year ended December 31, 2023, were $56.7 million compared
to $61.0 million for the year ended December 31, 2022. The decrease
in year-over-year G&A expenses is primarily due to the decrease
in consulting expenses related to accounting, recruiting, IT, and
other general expenses, plus a decrease in insurance costs.
Net Loss. For the quarter ended
December 31, 2023, Alector reported a net loss of $41.4 million, or
$0.49 per share, compared to a net loss of $52.4 million, or $0.63
net loss per share, for the same period in 2022. For the year ended
December 31, 2023, Alector reported a net loss of $130.4 million or
$1.56 net loss per share, compared to a net loss of $133.3 million
or $1.62 net loss per share, for the same period in 2022.
Cash Position. Cash, cash
equivalents, and investments were $548.9 million as of December 31,
2023. 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
anticipates, for the year ending 2024, 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.
Fourth Quarter and Full Year 2023
Conference Call
Alector’s management team will host a conference
call discussing Alector’s results for the fourth quarter and full
year 2023 and 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: Tuesday, February 27, 2024Time: 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
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, 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 for 2023, filed 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, |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
$ |
548,8611 |
|
|
$ |
712,851 |
|
Total assets |
|
621,827 |
|
|
|
787,648 |
|
Total current liabilities
(excluding deferred revenue) |
|
94,973 |
|
|
|
45,578 |
|
Deferred revenue (including
current portion) |
|
293,820 |
|
|
|
491,601 |
|
Total liabilities |
|
487,669 |
|
|
|
573,206 |
|
Total stockholders’
equity |
|
134,158 |
|
|
|
214,442 |
|
- Pro forma for Alector’s January
2024 equity offering, cash, cash equivalents and investments total
$620.0 million.
Consolidated Statement of Operations
Data(in thousands, except share and per share
data) |
|
|
Three Months EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
15,190 |
|
|
$ |
14,440 |
|
|
$ |
97,062 |
|
|
$ |
133,617 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
47,723 |
|
|
|
54,493 |
|
|
|
192,115 |
|
|
|
210,418 |
|
General and administrative |
|
14,920 |
|
|
|
15,385 |
|
|
|
56,687 |
|
|
|
61,033 |
|
Total operating expenses |
|
62,643 |
|
|
|
69,878 |
|
|
|
248,802 |
|
|
|
271,451 |
|
Loss from operations |
|
(47,453 |
) |
|
|
(55,438 |
) |
|
|
(151.740 |
) |
|
|
(137,834 |
) |
Other income, net |
|
7,685 |
|
|
|
3,731 |
|
|
|
26,561 |
|
|
|
7,778 |
|
Net loss before income tax |
|
(39,768 |
) |
|
|
(51,707 |
) |
|
|
(125,179 |
) |
|
|
(130,056 |
) |
Income tax expense |
|
1,666 |
|
|
|
721 |
|
|
|
5,212 |
|
|
|
3,254 |
|
Net loss |
$ |
(41,434 |
) |
|
$ |
(52,428 |
) |
|
$ |
(130,391 |
) |
|
$ |
(133,310 |
) |
Net loss per share, basic and
diluted |
$ |
(0.49 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.62 |
) |
Shares used in computing net loss
per share basic and diluted |
|
84,384,151 |
|
|
|
82,763,688 |
|
|
|
83,733,730 |
|
|
|
82,467,587 |
|
|
REFERENCES
1. U.S. Food and Drug Administration (FDA). Breakthrough
Therapy.
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
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