Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported third quarter
2023 financial results and recent portfolio and business updates.
As of September 30, 2023, Alector’s cash, cash equivalents and
investments totaled $588.9 million.
“We’ve made significant clinical advancements in our late-stage
immuno-neurology programs in the second half of 2023,” said Arnon
Rosenthal, Ph.D., Chief Executive Officer of Alector. “Notably, we
successfully completed enrollment in the INVOKE-2 Phase 2 trial in
collaboration with AbbVie, positioning us for a meaningful data
readout in the fourth quarter of 2024. In collaboration with GSK,
we achieved our enrollment target of 103 symptomatic participants
with frontotemporal dementia due to a progranulin gene mutation in
the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab.
Further, we are progressing our strategic partnership with GSK to
evaluate the potential of our progranulin programs in more
prevalent neurodegenerative diseases with patient screening
underway for the upcoming Phase 2 trial of AL101/GSK4257226 in
early Alzheimer’s disease.”
Gary Romano, M.D., Ph.D., Chief Medical Officer
of Alector added, “Our TREM2 and progranulin programs represent
significant opportunities to harness the brain’s innate immune
system to treat these neurodegenerative diseases. To enhance the
understanding of our novel programs, we will be hosting two events
in December with renowned scientific and clinical experts who will
provide greater insights into the potential of these programs.”
Recent Clinical Updates
Immuno-Neurology PortfolioProgranulin
Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed
in Collaboration with GSK
- In October 2023, Alector completed enrollment of 103
symptomatic and 16 at-risk participants with frontotemporal
dementia due to a progranulin gene mutation (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. Enrollment completion is subject to revised protocol
approval in countries outside the United States.
- Earlier this year, 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
INFRONT-3. The companies aligned with the FDA and EMA to conduct
the primary analysis on symptomatic participants, supporting an
enrollment target of approximately 90-100 symptomatic participants
in INFRONT-3.
- In the fourth quarter, GSK commenced patient screening in a
global Phase 2 clinical trial with AL101/GSK4527226 in early
Alzheimer’s disease (AD). Like Latozinemab, AL101 elevates
progranulin (PGRN) levels and has a different PK/PD profile.
- In September, at the 2023 Annual Meeting of the American
College of Clinical Pharmacology (ACCP), Alector and GSK presented
a poster on PK/PD modeling of PGRN elevation in blood and CSF based
on a Phase 1 clinical trial of AL101.
TREM2 Program (AL002) Being Developed in
Collaboration with AbbVie
- In September 2023, Alector completed enrollment in the
randomized, double-blind, placebo-controlled, dose-ranging,
INVOKE-2 Phase 2 clinical trial, with data anticipated in the
fourth quarter of 2024. The INVOKE-2 trial 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 monoclonal antibody that binds to TREM2 to increase TREM2
signaling and the functionality of microglia. It is the most
advanced TREM2 activating product candidate in clinical development
worldwide.
- Alector received payments totaling $12.5 million from AbbVie to
support enrollment in the INVOKE-2 trial.
Corporate Updates
- Alector will host two virtual events in December to discuss the
company’s TREM2 and PGRN programs. The events will include
presentations from leading scientific and clinical experts who will
provide their perspectives on the biological and genetic rationale
for the TREM2 and PGRN targets, share an overview of the current
FTD and AD treatment landscapes, and discuss the significant unmet
needs that remain in the treatment of these neurodegenerative
diseases. Each event will be webcast live on the Investor section
of the company’s website at https://investors.alector.com.
- Details on the events are as follows:
Diving Deep
into TREM2: Uncovering its Potential as a Therapeutic Target for
Alzheimer’s Disease
o
December 7, 2023, at 9am Pacific Standard Time (PST) / 12pm Eastern
Standard Time (EST)
A Detailed Review of PGRN: A
Pivotal Stage Program for Frontotemporal Dementia with Broad
Additional Opportunities Including Alzheimer’s Disease
o
December 13, 2023, at 8am PST / 11am EST
Third Quarter 2023 Financial
Results
Revenue. Collaboration revenue
for the quarter ended September 30, 2023, was $9.1 million,
compared to $14.9 million for the same period in 2022. This
decrease was primarily due to a $5.7 million decrease in
collaboration revenue recognized for the AL101 programs, including
a $4.6 million decrease in collaboration revenue due to an increase
in total expected costs to satisfy the performance obligations for
the AL101 AD program.
R&D Expenses. Total
research and development expenses for the quarter ended September
30, 2023, were $46.3 million, compared to $48.3 million for the
quarter ended September 30, 2022. The decrease of $2.0 million was
mainly due to the Company’s strategy to prioritize late-stage
programs.
G&A Expenses. Total general
and administrative expenses for the quarter ended September 30,
2023, were $13.4 million, compared to $14.3 million for the same
period in 2022. The decrease of $0.9 million was primarily due to a
decrease in consulting expenses related to accounting, recruiting,
IT, and other general expenses.
Net Loss. For the quarter ended
September 30, 2023, Alector reported a net loss of $44.5 million,
or $0.53 per share, compared to a net loss of $46.1 million, or
$0.56 net loss per share, for the same period in 2022.
Cash Position. Cash, cash
equivalents, and investments were $588.9 million as of September
30, 2023. Management expects that this will be sufficient to fund
current operations through 2025.
2023 Guidance. Management is
reiterating its guidance for the year ending 2023. The company
continues to anticipate collaboration revenue to be between $90 and
$100 million, total research and development to be between $210
million and $220 million and total general and administrative
expenses to be between $60 million and $65 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 and the timing of data readouts from such 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 Quarterly Report on Form 10-Q filed on
November 7, 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) |
|
|
|
|
|
September 30, |
|
December 31, |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
$ |
588,861 |
|
|
$ |
712,851 |
|
Total assets |
|
672,395 |
|
|
|
787,648 |
|
Total current liabilities
(excluding deferred revenue) |
|
74,841 |
|
|
|
45,578 |
|
Deferred revenue (including
current portion) |
|
310,409 |
|
|
|
491,601 |
|
Total liabilities |
|
509,840 |
|
|
|
573,206 |
|
Total stockholders’
equity |
|
162,555 |
|
|
|
214,442 |
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data) |
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Collaboration revenue |
$ |
9,109 |
|
|
$ |
14,852 |
|
|
$ |
81,872 |
|
|
$ |
119,177 |
|
Operating expense: |
|
|
|
|
|
|
|
|
Research and development |
|
46,328 |
|
|
|
48,348 |
|
|
|
144,392 |
|
|
|
155,925 |
|
General and administrative |
|
13,364 |
|
|
|
14,252 |
|
|
|
41,767 |
|
|
|
45,648 |
|
Total operating expenses |
|
59,692 |
|
|
|
62,600 |
|
|
|
186,159 |
|
|
|
201,573 |
|
Loss from operations |
|
(50,583 |
) |
|
|
(47,748 |
) |
|
|
(104,287 |
) |
|
|
(82,396 |
) |
Other income, net |
|
7,360 |
|
|
|
2,333 |
|
|
|
18,876 |
|
|
|
4,047 |
|
Net loss before income
tax |
|
(43,223 |
) |
|
|
(45,415 |
) |
|
|
(85,411 |
) |
|
|
(78,349 |
) |
Income tax expense |
|
1,252 |
|
|
|
733 |
|
|
|
3,546 |
|
|
|
2,533 |
|
Net loss |
$ |
(44,475 |
) |
|
$ |
(46,148 |
) |
|
$ |
(88,957 |
) |
|
$ |
(80,882 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.53 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.07 |
) |
|
$ |
(0.98 |
) |
Shares used in computing net
loss per share basic and diluted |
|
83,927,961 |
|
|
|
82,602,842 |
|
|
|
83,513,954 |
|
|
|
82,367,936 |
|
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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