Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported second quarter
2023 financial results and recent portfolio and business updates.
As of June 30, 2023, Alector’s cash, cash equivalents and
investments totaled $630.0 million.
“We expect to complete enrollment in the
INVOKE-2 Phase 2 clinical trial of AL002 in early Alzheimer’s
disease in the third quarter,” said Arnon Rosenthal, Ph.D., Chief
Executive Officer of Alector. “We have received positive feedback
from the FDA and the EMA to conduct a primary analysis on
approximately 90-100 symptomatic participants in our pivotal
INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN. We
anticipate completing enrollment in INFRONT-3 in the fourth quarter
of this year.”
Sara Kenkare-Mitra, Ph.D., President and Head of
Research and Development at Alector added, “While we continue to
progress our late-stage clinical programs, we are also
strategically advancing our innovative research portfolio to fuel
our pipeline. I am particularly excited about the ongoing
development of our blood brain barrier technology and the progress
on our preclinical program targeting GPNMB for the treatment of
Parkinson’s disease.”
Recent Clinical Updates
Immuno-Neurology
PortfolioTREM2 Program (AL002) Being Developed in
Collaboration with AbbVie
- Alector closed screening and plans
to complete enrollment in the INVOKE-2 clinical trial in the third
quarter of 2023, with data expected in the fourth quarter of 2024.
The INVOKE-2 Phase 2 trial is designed to evaluate the efficacy and
safety of AL002 in slowing disease progression in individuals with
early Alzheimer’s disease (AD).
- Alector presented an update on
INVOKE-2 at the Alzheimer’s Association International Conference
(AAIC) in July 2023. 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.
- 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.
- At AAIC, the company also presented
a poster on mouse model data demonstrating that TREM2 activation
improved AD biomarkers, including amyloid and tau.
Progranulin Programs (latozinemab
(AL001) and AL101/ GSK4527226) Being Developed in
Collaboration with GSK
- Alector and GSK held a Type C
meeting with the U.S. Food and Drug Administration (FDA) and
received scientific advice from the European Medicines Agency (EMA)
regarding the pivotal INFRONT-3 Phase 3 clinical trial of
latozinemab in participants with frontotemporal dementia due to
progranulin gene mutation (FTD-GRN).
- Alector and GSK aligned with the FDA and EMA to conduct the
primary analysis on symptomatic participants in INFRONT-3. Based on
feedback from the regulatory agencies, the companies performed a
sample size re-estimation that is anticipated to support a more
focused enrollment of approximately 90-100 symptomatic participants
for a treatment duration of 96 weeks.
- Alector plans to complete enrollment in INFRONT-3 in the fourth
quarter of 2023.
- In a recent data cut from the
FTD-C9orf72 cohort of the open label INFRONT-2 Phase 2 clinical
trial of latozinemab, Alector confirmed a two- to threefold
elevation in progranulin levels in CSF and plasma. The company
conducted an analysis of disease progression rates for the 14
participants who were treated with latozinemab compared with
baseline-matched controls from the ALLFTD registry. The small
sample size and a high degree of variability in disease progression
in both groups rendered the results uninformative regarding
treatment effect.
- In June 2023, Alector published a
manuscript in the Journal of Translational Medicine titled
“Latozinemab, a novel progranulin-elevating therapy for
frontotemporal dementia.” This publication details Alector’s
development of latozinemab and highlights findings demonstrating
that the sortilin receptor is a viable target for PGRN-elevating
therapy, particularly in patients who have a PGRN deficiency
leading to FTD.
- Alector and GSK plan to initiate a
global Phase 2 clinical trial with AL101/GSK4527226 in early AD.
The companies also plan to present a poster on the pharmacokinetic
and pharmacodynamic modeling of PGRN elevation in blood and CSF
based on a Phase 1 trial of AL101 at the American College of
Clinical Pharmacology (ACCP) being held in Bellevue, Washington
from September 10-12, 2023.
Early Research Pipeline
- Alector is developing its
proprietary, versatile blood brain barrier technology to
selectively support its next-generation product
candidates.
- The company is developing an
investigational therapy, ADP027, which modulates GPNMB for the
treatment of Parkinson’s disease.
Recent Corporate Updates
- In the second quarter of 2023, the
U.S. Patent and Trademark Office issued patents 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.
Second Quarter 2023 Financial
Results
Revenue. Collaboration revenue
for the quarter ended June 30, 2023, was $56.2 million, compared to
$79.9 million for the same period in 2022. The $23.6 million
decrease was mainly due to $68.9 million of collaboration revenue
recognized in the second quarter of 2022 due to changes in
estimated costs to satisfy the performance obligations resulting
from the termination of the AL003 program and a $16.7 million
decrease in revenue recognized for the latozinemab programs. This
was offset by a $33.5 million increase in revenue recognized for
the AL101 programs, including a cumulative non-cash revenue
adjustment due to contract modification to have GSK operationalize
the AL101 Phase 2 trial, and a $28.5 million increase to
collaboration revenue for the AL002 program due to changes in total
expected costs and the addition of AL002 LTE and patient
replacement revenue in 2023.
R&D Expenses. Total
research and development expenses for the quarter ended June 30,
2023, were $46.2 million, compared to $54.5 million for the quarter
ended June 30, 2022. The decrease of $8.4 million was mainly due to
the Company’s strategy to prioritize late-stage programs and higher
cost share amounts with GSK that are recorded as contra
expense.
G&A Expenses. Total general
and administrative expenses for the quarter ended June 30, 2023,
were $13.6 million, compared to $15.8 million for the same period
in 2022. The decrease of $2.2 million was primarily due to a
decrease in consulting expenses related to accounting, recruiting,
IT, and other general expenses.
Net Income. For the quarter
ended June 30, 2023, Alector reported a net income of $1.4 million,
or $0.02 net income per share, compared to a net income of $9.9
million, or $0.12 net income per share, for the same period in
2022.
Cash Position. Cash, cash
equivalents, and investments were $630.0 million as of June 30,
2023. Management continues to expect that this will be sufficient
to fund current operations through 2025.
2023 Guidance. Management is
revising guidance for the year ending 2023, increasing
collaboration revenue to now be between $90 million and $100
million, decreasing total research and development expenses to now
be between $210 million and $220 million and tightening
expectations for total general and administrative expenses to now
be between $60 million and $65 million.
Second Quarter 2023 Conference
Call
Alector’s management team will host a conference
call discussing Alector’s results for the second quarter of 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: Thursday, August 3, 2023Time: 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 target
genetically defined patient populations in frontotemporal dementia
and Alzheimer’s disease. 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 and the timing of enrollment in and
data readouts from such trials, expected milestones, including the
proposed timing on engagement with regulatory authorities for
certain product candidates, 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 Quarterly Report
on Form 10-Q filed on August 3, 2023 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) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
|
$ |
630,048 |
|
$ |
712,851 |
Total assets |
|
|
708,737 |
|
|
787,648 |
Total current liabilities
(excluding deferred revenue) |
|
|
63,720 |
|
|
45,578 |
Deferred revenue (including
current portion) |
|
|
313,893 |
|
|
491,601 |
Total liabilities |
|
|
512,431 |
|
|
573,206 |
Total stockholders’
equity |
|
|
196,306 |
|
|
214,442 |
|
|
|
|
|
|
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
56,214 |
|
|
|
$ |
79,851 |
|
|
$ |
72,763 |
|
|
$ |
104,325 |
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
46,177 |
|
|
|
|
54,534 |
|
|
|
98,064 |
|
|
|
107,577 |
|
General and administrative |
|
|
13,626 |
|
|
|
|
15,842 |
|
|
|
28,403 |
|
|
|
31,396 |
|
Total operating expenses |
|
|
59,803 |
|
|
|
|
70,376 |
|
|
|
126,467 |
|
|
|
138,973 |
|
Income (loss) from
operations |
|
|
(3,589 |
) |
|
|
|
9,475 |
|
|
|
(53,704 |
) |
|
|
(34,648 |
) |
Other income, net |
|
|
6,357 |
|
|
|
|
1,450 |
|
|
|
11,516 |
|
|
|
1,714 |
|
Net income (loss) before
income tax |
|
|
2,768 |
|
|
|
|
10,925 |
|
|
|
(42,188 |
) |
|
|
(32,934 |
) |
Income tax expense |
|
|
1,393 |
|
|
|
|
1,042 |
|
|
|
2,294 |
|
|
|
1,800 |
|
Net income (loss) |
|
$ |
1,375 |
|
|
|
$ |
9,883 |
|
|
$ |
(44,482 |
) |
|
$ |
(34,734 |
) |
Net income (loss) per
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
share |
|
$ |
0.02 |
|
|
|
$ |
0.12 |
|
|
$ |
(0.53 |
) |
|
$ |
(0.42 |
) |
Diluted net income (loss) per
share |
|
$ |
0.02 |
|
|
|
$ |
0.12 |
|
|
$ |
(0.53 |
) |
|
$ |
(0.42 |
) |
Weighted-average shares used
in calculating: |
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
share |
|
|
83,497,125 |
|
|
|
|
82,394,784 |
|
|
|
83,186,052 |
|
|
|
82,248,880 |
|
Diluted net income (loss) per
share |
|
|
83,566,293 |
|
|
|
|
82,588,368 |
|
|
|
83,186,052 |
|
|
|
82,248,880 |
|
|
Alector Contacts:
AlectorKatie Hogan 202-549-0557katie.hogan@alector.com
1AB (media) Dan Budwick 973-271-6085 dan@1abmedia.com
Argot Partners (investors) Laura Perry 212.600.1902
alector@argotpartners.com
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