Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported first quarter
2023 financial results and recent portfolio and business updates.
As of March 31, 2023, Alector’s cash, cash equivalents and
investments totaled $669.3 million.
“We continue the momentum built in 2022, making steady progress
in the first quarter advancing our late-stage immuno-neurology
programs,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of
Alector. “We remain on track to engage with regulatory authorities
this summer regarding the INFRONT-3 trial of latozinemab, and we
are targeting early 2025 for a data readout from the pivotal trial.
As we look ahead to the remainder of 2023, we anticipate important
milestones across our pipeline, including completing enrollment in
the Phase 2 clinical trial of our TREM2 candidate, AL002, in
patients with early Alzheimer’s disease and new data from the
INFRONT-2 clinical trial of latozinemab in FTD-C9orf72. I look
forward to providing updates on our late-stage clinical and early
research programs in the coming months.”
Gary Romano, M.D., Ph.D., Chief Medical Officer of Alector
added, “We have an exciting year ahead of us as we continue to
progress latozinemab, AL101 and AL002 through the clinic. We are
very encouraged by recent drug development programs in neurological
disorders that have successfully leveraged treatment effects on
biomarkers to support clinical efficacy. All our clinical studies
are designed to deliver robust biomarker and clinical data that
will evaluate the therapeutic effects of our antibody candidates on
disease pathophysiology and clinical disease progression. In our
Phase 2 INFRONT-2 trial of latozinemab, we have observed
normalization of CSF and plasma levels of GFAP. Increased levels of
GFAP are associated with faster rates of brain atrophy in FTD. We
look forward to sharing additional data from the FTD-C9orf72 cohort
later this year, and we continue to advance our pivotal Phase 3
INFRONT-3 study, which evaluates those biomarkers and clinical
endpoints in a double-blinded, randomized, placebo-controlled trial
of latozinemab for the treatment of FTD-GRN.”
Recent Clinical Updates
Immuno-Neurology PortfolioProgranulin
Programs (latozinemab (AL001) and AL101) Being Developed in
Collaboration with GSK
- Alector is preparing to engage with regulatory authorities in
mid-2023 to discuss statistical analysis plans for the pivotal
Phase 3 INFRONT-3 clinical trial evaluating the efficacy and safety
of latozinemab (AL001) in patients with frontotemporal dementia due
to a progranulin gene mutation (FTD-GRN). Emerging knowledge in the
field may enable completion of the study with fewer patients and/or
a shorter treatment duration. The company is targeting an INFRONT-3
data readout in early 2025 with the potential for a Biologics
License Application (BLA) filing in late 2025 subject to regulatory
discussion outcomes.
- As previously announced, Alector plans to present additional
data from the INFRONT-2 Phase 2 clinical trial of latozinemab in
FTD-C9orf72 during the second half of 2023. The data is expected to
include additional results from the entire FTD-C9orf72 cohort. To
date, the company has presented 12-month results from six
symptomatic FTD-C9orf72 trial participants treated with
latozinemab. The FTD-C9orf72 cohort represents the first clinical
dataset in an indication where latozinemab elevated progranulin
above physiological levels, supporting the company’s efforts to
expand the progranulin franchise into additional neurodegenerative
disease indications, including Alzheimer’s disease (AD),
Parkinson’s disease (PD) and amyotrophic lateral sclerosis
(ALS).
- The company submitted a poster, PK/PD modeling of progranulin
elevation in blood and CSF to support AL101 dose selection and
Phase 2 study design, for the 2023 Annual Meeting of the American
College of Clinical Pharmacology (ACCP) being held in Bellevue,
Washington from September 10-12, 2023. The pharmacokinetic and
pharmacodynamic (PK/PD) modeling supports dose selection for the
Phase 2 study of AL101 in AD. AL101 is intended to elevate
progranulin levels in a manner similar to latozinemab but with
different PK/PD properties, and the company plans to investigate
AL101 for the treatment of AD and PD. As previously reported,
Alector and GSK plan to initiate a global Phase 2 clinical trial
with AL101 in early AD.
TREM2 Program (AL002) Being Developed in Collaboration
with AbbVie
- Alector received a $17.8 million milestone payment from AbbVie
in March 2023 after enrolling and dosing the first patient in a
long-term extension (LTE) of the INVOKE-2 Phase 2 clinical trial in
patients with early AD. Alector may also receive up to an
additional $12.5 million from AbbVie to support enrollment in the
INVOKE-2 trial. Alector is on track to complete enrollment in the
trial in the third quarter of 2023, with top-line data expected by
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.
- 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 strategically invest in and advance its
innovative research portfolio to fuel its development pipeline. The
company’s target discovery engine robustly integrates functional
genomics, external and internal data, and machine learning.
Additionally, the company is applying its proprietary blood brain
barrier technologies to support its next-generation product
candidates.
Recent Corporate Updates
- Kristina Cutter, M.P.H., was promoted to Chief Regulatory,
Pharmacovigilance, and Quality Assurance Officer. Ms. Cutter has
over 20 years of biotechnology industry experience and oversees the
global regulatory and safety strategy as well as Alector’s quality
systems, which ensure the right to operate across Alector’s
immuno-neurology portfolios.
First Quarter 2023 Financial Results
Revenue. Collaboration revenue for the quarter
ended March 31, 2023, was $16.5 million, compared to $24.5 million
for the same period in 2022. This decrease was primarily due to
less revenue recognized from the GSK agreement.
R&D Expenses. Total
research and development expenses for the quarter ended March 31,
2023, were $51.9 million, compared to $53.0 million for the same
period in 2022. The decrease in R&D expenses was mainly driven
by the decrease in our latozinemab programs due to the timing of
manufacturing activities offset by an increase in the AL002 program
due to higher enrollment activities and the addition of the LTE
trial.
G&A Expenses. Total general and
administrative expenses for the quarter ended March 31, 2023, were
$14.8 million, compared to $15.6 million for the same period in
2022 mainly driven by a decrease in consulting expenses related to
accounting, recruiting, IT, and other general expenses.
Net Loss. For the quarter ended
March 31, 2023, Alector reported a net loss of $45.9 million, or
$0.55 per share, compared to a net loss of $44.6 million, or $0.54
per share, for the same period in 2022.
Cash Position. Cash, cash equivalents, and
investments were $669.3 million as of March 31, 2023. Management
expects that this will be sufficient to fund current operations
through 2025.
2023 Guidance. Management anticipates, for the
year ending 2023, collaboration revenue to be between $15 million
and $25 million, total research and development expenses to be
between $225 million and $245 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 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 Statements
This 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, 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 May 4, 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) |
|
|
March 31, |
|
December 31, |
|
2023 |
|
2022 |
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
$ |
669,329 |
|
$ |
712,851 |
Total assets |
|
748,342 |
|
|
787,648 |
Total current liabilities
(excluding deferred revenue) |
|
37,527 |
|
|
45,578 |
Deferred revenue (including
current portion) |
|
492,852 |
|
|
491,601 |
Total liabilities |
|
565,327 |
|
|
573,206 |
Total stockholders’
equity |
|
183,015 |
|
|
214,442 |
|
|
|
|
|
|
Consolidated Statement of Operations Data |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months
Ended March 31, |
|
2023 |
|
2022 |
Collaboration revenue |
$ |
16,549 |
|
|
$ |
24,474 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
51,887 |
|
|
|
53,043 |
|
General and administrative |
|
14,777 |
|
|
|
15,554 |
|
Total operating expenses |
|
66,664 |
|
|
|
68,597 |
|
Loss from operations |
|
(50,115 |
) |
|
|
(44,123 |
) |
Other income, net |
|
5,159 |
|
|
|
264 |
|
Loss before income tax |
|
(44,956 |
) |
|
|
(43,859 |
) |
Income tax expense |
|
901 |
|
|
|
758 |
|
Net loss |
$ |
(45,857 |
) |
|
$ |
(44,617 |
) |
Net loss per share, basic and
diluted |
$ |
(0.55 |
) |
|
$ |
(0.54 |
) |
Shares used in computing net
loss per share basic and diluted |
|
83,102,296 |
|
|
|
82,102,191 |
|
|
|
|
|
|
|
|
|
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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