Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported second quarter
2024 financial results and recent portfolio and business updates.
As of June 30, 2024, Alector’s cash, cash equivalents and
investments totaled $503.3 million.
“Alector’s significant progress in recent months
has set the stage for a transformative period ahead, as we approach
key clinical catalysts for our maturing, potential first-in-class
immuno-neurology programs,” said Arnon Rosenthal, Ph.D., Chief
Executive Officer of Alector. “We remain on track to report data
from INVOKE-2, our Phase 2 clinical trial in early Alzheimer’s
disease for AL002, in the fourth quarter, and we are encouraged
that the recently reported patient baseline characteristics reflect
a study population appropriate for the clinical evaluation of a
TREM2 agonist in this indication.”
Dr. Rosenthal continued, “In addition, the
recent Breakthrough Therapy Designation for latozinemab in
frontotemporal dementia with a progranulin gene mutation has
provided the opportunity for increased interactions with the FDA
about this program, and we now have additional clarity on how key
biomarkers may support our path to a potential regulatory
submission. In parallel, we are continuing to enroll patients in
the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. With a cash
runway that extends through 2026, we are in a strong financial
position as we approach these key milestones.”
Sara Kenkare-Mitra, Ph.D., President and Head of
Research and Development at Alector added, “In June, Alector hosted
a virtual research and development event focused on the Alector
Brain Carrier (ABC), our proprietary, versatile blood-brain barrier
technology. We believe our ABC technology platform has the
potential to deliver novel drugs safely into the CNS, enabling
potential best-in-class therapeutics for patients suffering from
neurological disorders. We look forward to providing updates on our
progress in the future.”
Recent Clinical Updates
Immuno-Neurology
PortfolioProgranulin Programs (latozinemab (AL001)
and AL101/GSK4527226) Being Developed in Collaboration with
GSK
- In a recent Type B interaction with the U.S. Food and Drug
Administration (FDA), Alector and GSK received feedback on the
potential future Biologics License Application (BLA) for
latozinemab targeting frontotemporal dementia with a progranulin
gene mutation (FTD-GRN). The FDA has indicated that it would
consider the effects of latozinemab on plasma and cerebrospinal
fluid concentrations of progranulin (PGRN) as confirmatory
evidence, supplementing the potential clinical effects of
latozinemab in FTD-GRN, pending BLA review. The companies also
aligned with the agency on disease-relevant fluid and imaging
biomarkers that may be considered as supportive evidence of
clinical efficacy, subject to BLA review. These include biomarkers
of astrocyte function, neurodegeneration, and brain atrophy. Based
on the FDA feedback, Alector and GSK remain confident that the
totality of evidence, including the primary clinical endpoint and
biomarkers, could provide a path to potential approval for
latozinemab. The Type B interaction occurred after the FDA granted
Breakthrough Therapy Designation to latozinemab for the potential
treatment of FTD-GRN earlier this year.
- The pivotal, randomized, double-blind, placebo-controlled
INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN is
ongoing. Enrollment was completed in October 2023, and the
treatment duration is 96 weeks. INFRONT-3 is evaluating the safety
and efficacy of latozinemab in slowing disease progression in
individuals with FTD-GRN. The primary endpoint in INFRONT-3 is
disease progression as measured by the Clinical Dementia Rating
scale plus National Alzheimer’s Disease Coordinating Center
Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC
FTLD-SB). The trial also employs other clinical and functional
outcome assessments.
- Alector plans to present the poster “Baseline characteristics
for INFRONT-3: A Phase 3, double-blind, placebo-controlled 96-week
study evaluating latozinemab in FTD-GRN” at the International
Society for Frontotemporal Dementias (ISFTD) in Amsterdam from
September 19-22, 2024.
- Enrollment is ongoing in the PROGRESS-AD global Phase 2
clinical trial of AL101/GSK4527226 in early Alzheimer’s disease
(AD). Alector and GSK are co-developing AL101 for the potential
treatment of more prevalent neurodegenerative diseases, including
AD and Parkinson’s disease.
- In July 2024, Alector and GSK presented posters highlighting
PGRN and AL101 at the Alzheimer's Association International
Conference® 2024 (AAIC®). The presentations included data
supporting the therapeutic hypothesis of increasing PGRN levels for
the potential treatment of AD and the design of the ongoing
PROGRESS-AD Phase 2 clinical trial.
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 monoclonal antibody
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.
- At AAIC® in July 2024, Alector presented data highlighting the
patient baseline characteristics for the INVOKE-2 study. The data
confirm the intended study population for testing the effects of
AL002, a novel TREM2 agonist, in early AD. Of note, for those
participants with amyloid PET assessed at baseline, the mean
(standard deviation) in centiloids was 100.1 (38.9), consistent
with expectations for an early AD population in INVOKE-2. In a
separate poster, Alector also presented data supporting the use of
a blood-based amyloid test for screening AD patients eligible for
participation in the INVOKE-2 trial.
- AbbVie has an exclusive option to globally develop and
commercialize AL002, upon receipt and evaluation of the INVOKE-2
data. AbbVie’s exercise of that option would prompt a $250 million
payment to Alector.
Early Research Pipeline
- Alector is actively progressing its 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.
Initial work has focused on transferrin receptor (TfR) and CD98hc
targets, which have distinct expression profiles and cellular
trafficking pathways but have both been shown to be highly
expressed at the BBB and able to drive brain uptake when utilized
as transcytosis receptors.
- In June 2024, Alector hosted a virtual research and development
event discussing the company’s ABC technology platform in detail.
The event included a presentation from Dr. Zhiqiang An, Ph.D.,
Professor & Robert A. Welch Distinguished University Chair in
Chemistry and Director of the Texas Therapeutics Institute at
UTHealth Houston, who provided insights into emerging technologies
for BBB modulation and discussed future directions and
opportunities in the field.
Second Quarter 2024 Financial
Results
Revenue. Collaboration revenue
for the quarter ended June 30, 2024, was $15.1 million, compared to
$56.2 million for the same period in 2023. The decrease was mainly
due to a $35.7 million decrease in revenue recognized for the AL101
programs, including a cumulative non-cash revenue adjustment due to
a contract modification in the second quarter of 2023 to have GSK
operationalize the AL101 Phase 2 study. The decrease is partially
due to a $15.2 million decrease in revenue recognized for the AL002
program due to the addition of AL002 LTE and patient replacement
revenue in 2023. This was offset by a $9.8 million increase in
revenue recognized for the latozinemab programs.
R&D Expenses. Total
research and development expenses for the quarter ended June 30,
2024, were $46.3 million, compared to $46.2 million for the quarter
ended June 30, 2023. The increase was mainly driven by the
Company’s prioritization on selected late-stage programs.
G&A Expenses. Total general
and administrative expenses for the quarter ended June 30, 2024,
were $14.4 million, compared to $13.6 million for the quarter ended
June 30, 2023.
Net Income (Loss). For the
quarter ended June 30, 2024, Alector reported a net loss of $38.7
million, or $0.40 per share, compared to a net income of $1.4
million, or $0.02 net income per share, for the same period in
2023.
Cash Position. Cash, cash equivalents, and
investments were $503.3 million as of June 30, 2024. Management
expects that this will be sufficient to fund current operations
through 2026.
2024 Guidance. The Company
continues to anticipate collaboration revenue to be between $60
million and $70 million. Management has updated its total research
and development expenses to be between $210 million and $220
million and reiterated total general and administrative expenses to
be between $60 million and $70 million.
Second Quarter 2024 Conference
Call
Alector’s management team will host a conference
call discussing Alector’s results for the second quarter of 2024
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: Wednesday, August 7, 2024 Time: 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, blood-brain barrier technology
platform, planned and ongoing preclinical studies and clinical
trials, anticipated timing of and detail regarding release of data
for INVOKE-2 and 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-Q filed on August 7, 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) |
|
|
|
June 30, |
|
December 31, |
|
|
2024 |
|
2023 |
Cash, cash equivalents, and marketable securities |
|
$ |
503,334 |
|
$ |
548,861 |
Total assets |
|
|
570,729 |
|
|
621,827 |
Total current liabilities
(excluding deferred revenue) |
|
|
83,721 |
|
|
94,973 |
Deferred revenue (including
current portion) |
|
|
263,544 |
|
|
293,820 |
Total liabilities |
|
|
420,162 |
|
|
487,669 |
Total stockholders’
equity |
|
|
150,567 |
|
|
134,158 |
Consolidated Statement of Operations Data |
(in thousands, except share and per share
data) |
|
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
Collaboration revenue |
|
$ |
15,083 |
|
|
|
$ |
56,214 |
|
|
|
$ |
30,976 |
|
|
|
$ |
72,763 |
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
46,314 |
|
|
|
|
46,177 |
|
|
|
|
91,481 |
|
|
|
|
98,064 |
|
General and administrative |
|
|
14,375 |
|
|
|
|
13,626 |
|
|
|
|
28,809 |
|
|
|
|
28,403 |
|
Total operating expenses |
|
|
60,689 |
|
|
|
|
59,803 |
|
|
|
|
120,290 |
|
|
|
|
126,467 |
|
Loss from operations |
|
|
(45,606 |
) |
|
|
|
(3,589 |
) |
|
|
|
(89,314 |
) |
|
|
|
(53,704 |
) |
Other income, net |
|
|
7,003 |
|
|
|
|
6,357 |
|
|
|
|
14,639 |
|
|
|
|
11,516 |
|
Income (loss) before income
tax |
|
|
(38,603 |
) |
|
|
|
2,768 |
|
|
|
|
(74,675 |
) |
|
|
|
(42,188 |
) |
Income tax expense |
|
|
73 |
|
|
|
|
1,393 |
|
|
|
|
80 |
|
|
|
|
2,294 |
|
Net income (loss) |
|
$ |
(38,676 |
) |
|
|
$ |
1,375 |
|
|
|
$ |
(74,755 |
) |
|
|
$ |
(44,482 |
) |
Net income (loss) per
share: |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share,
basic |
|
$ |
(0.40 |
) |
|
|
$ |
0.02 |
|
|
|
$ |
(0.78 |
) |
|
|
$ |
(0.53 |
) |
Net income (loss) per share,
diluted |
|
$ |
(0.40 |
) |
|
|
$ |
0.02 |
|
|
|
$ |
(0.78 |
) |
|
|
$ |
(0.53 |
) |
Weighted averages shares used
in calculating: Shares used in computing net income (loss) per
share, basic |
|
|
96,674,921 |
|
|
|
|
83,497,125 |
|
|
|
|
95,242,548 |
|
|
|
|
83,186,052 |
|
Shares used in computing net
income (loss), per shares, diluted |
|
|
96,674,921 |
|
|
|
|
83,566,293 |
|
|
|
|
95,242,548 |
|
|
|
|
83,186,052 |
|
|
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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