ALEC Alector Inc.

26.81
+1.35  (+5%)
Previous Close 25.46
Open 26.02
52 Week Low 9.12
52 Week High 43.32
Market Cap $2,168,270,091
Shares 80,875,423
Float 58,130,166
Enterprise Value $1,789,117,269
Volume 1,410,651
Av. Daily Volume 907,540
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Upcoming Catalysts

Drug Stage Catalyst Date
AL003
Alzheimer’s disease
Phase 1
Phase 1
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AL101
Healthy volunteers
Phase 1a
Phase 1a
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Drug Pipeline

Drug Stage Notes
AL001
Amyotrophic lateral sclerosis (ALS)
Phase 2
Phase 2
Phase 2 trial initiated dosing, September 9, 2021.
AL001 (INFRONT-2)
Frontotemporal Dementia
Phase 2
Phase 2
Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
AL002 (INVOKE-2)
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 trial ongoing. Dosing commenced January 2021.
AL001 (INFRONT-3)
Frontotemporal Dementia
Phase 3
Phase 3
Phase 3 commencement of dosing announced July 24, 2020.

Latest News

  1. Randomized, placebo-controlled Phase 2 trial will enroll patients with C9orf72-associated ALS

    SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that the first participant has been dosed in a Phase 2 clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AL001 in people with amyotrophic lateral sclerosis (ALS) who carry a C9orf72 mutation. AL001 is being developed in collaboration with GlaxoSmithKline (GSK).

    AL001 is a potential first-in-class monoclonal antibody designed to elevate progranulin, a key regulator of immune activity in the brain. Alector is also actively enrolling…

    Randomized, placebo-controlled Phase 2 trial will enroll patients with C9orf72-associated ALS

    SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that the first participant has been dosed in a Phase 2 clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AL001 in people with amyotrophic lateral sclerosis (ALS) who carry a C9orf72 mutation. AL001 is being developed in collaboration with GlaxoSmithKline (GSK).

    AL001 is a potential first-in-class monoclonal antibody designed to elevate progranulin, a key regulator of immune activity in the brain. Alector is also actively enrolling the Phase 3 INFRONT-3 pivotal clinical study of AL001 in individuals at-risk for and symptomatic patients with frontotemporal dementia (FTD) who carry a progranulin mutation (FTD-GRN), as well as currently enrolling the Phase 2 INFRONT-2 study in symptomatic patients with FTD who carry a C9orf72 mutation (FTD-C9orf72).

    "AL001 has shown encouraging results in patients with FTD-GRN, rapidly increasing progranulin levels and normalizing inflammatory biomarkers along the disease cascade that contribute to neurodegeneration," said Sam Jackson, M.D., Alector's interim Chief Medical Officer. "Frontotemporal dementia and amyotrophic lateral sclerosis share common clinical, pathological and genetic features and it is now recognized that FTD and ALS are two diseases that form a broad neurodegenerative continuum. ALS is the first of several potential indications beyond frontotemporal dementia where we believe AL001 may have a positive impact on brain health by elevating progranulin levels."

    Both decreased progranulin levels and mutations in the chromosome 9 open reading frame 72 (C9orf72) gene are associated with abnormal accumulation of the TAR DNA-binding protein 43 (TDP-43). Excess aggregation of TDP-43 in brain cells is thought to lead to neuronal cell death and is associated with multiple neurodegenerative diseases, including ALS, where 95% of patients with ALS have TDP-43 pathology. In preclinical studies using multiple models of acute and chronic neurodegeneration, increasing progranulin levels has been shown in the literature to reverse and be protective against TDP-43 pathology.

    Dr. Jackson continued, "We have seen consistent clinical and preclinical evidence of AL001's ability to increase progranulin levels in the brain, and we are optimistic that in doing so, we may be able to mitigate or halt the downstream damage caused to motor neurons by excess TDP-43, and thereby slow the progression of ALS. We look forward to exploring the potential of AL001 to improve outcomes for ALS patients."

    "ALS, also known as Lou Gehrig's disease, is a progressive and ultimately fatal neurodegenerative condition, with few FDA-approved treatment options. As we learn more about the genetic and biologic underpinnings of ALS, there is an opportunity to develop targeted treatments that address the mechanism of disease," said Katharine Nicholson, M.D., neurologist and ALS clinical trialist at the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and the principal investigator for the Phase 2 study of AL001. "TDP-43 accumulation is found in the majority of patients with ALS, and by elevating progranulin levels, it is hoped that AL001 may have a neuroprotective effect. I look forward to working with Alector to study AL001's disease-modifying potential in ALS."

    The Phase 2 trial of AL001 is a randomized, double-blind, placebo-controlled, multicenter study that is expected to enroll approximately 45 adult participants with C9orf72-associated ALS. Participants will receive AL001 or placebo intravenously every four weeks for 24 weeks added to their current treatment regimen. The primary endpoint of the study is safety, tolerability, pharmacokinetics and pharmacodynamics of AL001, including plasma and cerebrospinal fluid (CSF) progranulin levels. The Phase 2 will also gather data on changes to multiple liquid biomarkers. Taken together, these data are intended to inform trial design and dosing for future efficacy studies of AL001 in ALS.

    About Amyotrophic Lateral Sclerosis

    Amyotrophic lateral sclerosis (ALS) is a devastating, fatal, progressive neurodegenerative disorder. In ALS, the motor neurons in the brain and spinal cord die, resulting in weakness, muscle atrophy, paralysis and frequently, cognitive impairment, before resulting in death from respiratory failure. Each year, more than 5,000 people in the U.S. are diagnosed with ALS and an estimated 20,000 are living with the disease. Mutations within multiple genes, including the C9orf72 gene, are believed to cause the disease. Such mutations can lead to an accumulation of TDP-43 in the cells resulting in neuronal death and an estimated 95% of ALS cases are linked to TDP-43 pathology. Approximately 40-50% of all familial ALS and up to 10% of sporadic ALS cases are attributed to the C9orf72 mutation. Currently approved medications for ALS confer only a modest survival benefit and new treatment options are urgently needed.

    About AL001

    Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 is a novel human monoclonal antibody that elevates levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also being evaluated in a Phase 2 study in symptomatic patients with FTD who carry a C9orf72 mutation, and a Phase 2 study in patients with amyotrophic lateral sclerosis (ALS) who carry a C9orf72 mutation. In July 2021, Alector and GSK announced a global collaboration to co-develop AL001 for a range of neurodegenerative diseases, including FTD, ALS, Parkinson's disease and Alzheimer's disease.

    About Alector

    Alector 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 the 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. This scientific approach is also the basis for the company's immuno-oncology programs. 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. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to market conditions, Alector and its business as set forth in our Quarterly Report on Form 10-Q, as filed on August 3, 2021 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.

    Alector Contacts

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Laura Perry/Eric Kasper

    Argot Partners

    212.600.1902

    alector@argotpartners.com

     



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  2. Planned Transitions Announced for Shehnaaz Suliman, M.D., MBA, MPhil, President and Chief Operating Officer and Robert Paul, M.D., Ph.D., Chief Medical Officer

    Sam Jackson, M.D., MBA, Appointed Interim Chief Medical Officer

    SOUTH SAN FRANCISCO, California, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Shehnaaz Suliman, M.D., MBA, M.Phil., and Robert Paul, M.D., Ph.D., will be stepping down from their respective roles as President and Chief Operating Officer and Chief Medical Officer. Each will continue to serve for a transition period and plan to remain available as advisors until the end of 2021. Sam Jackson, M.D., MBA, Senior Vice…

    Planned Transitions Announced for Shehnaaz Suliman, M.D., MBA, MPhil, President and Chief Operating Officer and Robert Paul, M.D., Ph.D., Chief Medical Officer

    Sam Jackson, M.D., MBA, Appointed Interim Chief Medical Officer

    SOUTH SAN FRANCISCO, California, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Shehnaaz Suliman, M.D., MBA, M.Phil., and Robert Paul, M.D., Ph.D., will be stepping down from their respective roles as President and Chief Operating Officer and Chief Medical Officer. Each will continue to serve for a transition period and plan to remain available as advisors until the end of 2021. Sam Jackson, M.D., MBA, Senior Vice President, Clinical Sciences, will assume the role of interim Chief Medical Officer. Dr. Jackson is an established leader with more than 15 years of experience leading clinical development functions. He joined Alector in 2020 and among his primary responsibilities is the development of AL001, which is currently in Phase 3 clinical testing for the treatment of frontotemporal dementia.  

    "Shehnaaz and Robert's contributions, including recruiting strong senior leaders such as Sam, have transformed Alector into a leading, well resourced, immuno-neurology drug developer, with one of the deepest and most advanced pipelines of neurodegenerative therapeutic candidates in industry. On behalf of the Alector team and board, we are grateful for their leadership and I am confident that they will excel in their future endeavors," said Arnon Rosenthal, Ph.D., Alector's co-founder and Chief Executive Officer. "I am looking forward to the next phase of Alector's growth; with a solid foundation and resources in place, we are well positioned to advance our clinical-stage programs as well as our pipeline of preclinical immuno-neurology and innate immuno-oncology candidates."

    Alector is currently conducting six clinical studies for four clinical-stage immune-neurology candidates, with plans to advance a new candidate for neurodegenerative diseases and two immune-oncology candidates into the clinic in 2022.

    Dr. Suliman joined Alector in 2019 and provided strategic and operational leadership while overseeing the company's early development, portfolio, business development, finance, investor relations, legal and administrative functions.

    "It has been my privilege to work alongside Arnon and our colleagues to drive significant value and substantial growth during my time at Alector," said Dr. Suliman. "The company is well positioned to succeed, and I am looking forward to pursuing a future chief executive leadership role with a focus on advancing groundbreaking scientific insights into viable treatments that can improve patient's lives."

    Robert Paul joined Alector in 2016 and has been responsible for advancing all four of Alector's immuno-neurology programs into the clinic and laying the foundation for the company's overarching development strategy, which includes taking a portfolio approach and leveraging biomarkers to inform clinical studies and efficient go/no go decisions.

    "By bringing four drug candidates into the clinic and advancing AL001 to Phase 3 in under two years we have achieved more in the time that I have been with Alector than I ever expected," said Dr. Paul. "With multiple candidates currently in all phases of development, more data on the horizon, and emerging programs preparing to enter the clinic, I am excited and optimistic about Alector's future."

    About Dr. Jackson

    Sam Jackson, M.D., MBA, joined Alector as the Senior Vice President of Clinical Development in 2020 bringing more than 15 years of industry experience leading clinical development for novel neurologic, immunologic and ophthalmic programs. At Alector, Dr. Jackson oversees the Clinical Operations and Neurology Clinical Science groups developing Alector's immuno-neurology therapies for frontotemporal dementia, Alzheimer's disease and other neurodegenerative conditions.

    Among his industry experiences prior to Alector, Dr. Jackson served as the Chief Medical Officer of Alkahest where he helped to build the clinical organization and designed and initiated four Phase 2 trials in neurological and ophthalmologic diseases. Earlier, he was Executive Director, Clinical Development and Drug Safety at Dynavax Technologies where he ran the pivotal Phase 3 trial that resulted in product approval for HEPLISAV-B™. Before joining Dynavax, Dr. Jackson held positions of increasing responsibility at Genentech, serving as Project Team Leader where he was responsible for the development and strategic decision making for a clinical-stage ophthalmology program. Dr. Jackson started his industry career at Amgen with a focus on safety and pharmacovigilance. He is a board-certified emergency physician with fellowship training in Medical Toxicology. Dr. Jackson received his joint M.D. and MBA degrees from the University of Pennsylvania where he was a 21st Century Scholar.

    About Alector

    Alector 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 the 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. This scientific approach is also the basis for the company's immuno-oncology programs. 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. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to market conditions, Alector and its business as set forth in Alector's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 3, 2021, 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.

    Alector Contacts

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Laura Perry/Eric Kasper

    Argot Partners

    212.600.1902

    alector@argotpartners.com



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  3. SOUTH SAN FRANCISCO, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that management will participate in the following upcoming virtual investor conferences:

    • Citi's 16th Annual Biopharma Virtual Conference
      • Wednesday, September 8, 2021 at 11:35 a.m. ET, What's Next for Neurodegenerative Diseases Panel
      • Thursday, September 9, 2021 at 1:25 p.m. ET, Fireside Chat
    • The 2021 Wells Fargo Virtual Healthcare Conference
      • Friday, September 10, 2021 at 2:00 p.m. ET, Corporate Presentation
    • The Morgan Stanley 19th Annual Global Healthcare Conference
      • Monday, September 13, 2021 at 11:45 a.m. ET, Fireside Chat

    Live webcasts of each conference presentation…

    SOUTH SAN FRANCISCO, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that management will participate in the following upcoming virtual investor conferences:

    • Citi's 16th Annual Biopharma Virtual Conference
      • Wednesday, September 8, 2021 at 11:35 a.m. ET, What's Next for Neurodegenerative Diseases Panel
      • Thursday, September 9, 2021 at 1:25 p.m. ET, Fireside Chat
    • The 2021 Wells Fargo Virtual Healthcare Conference
      • Friday, September 10, 2021 at 2:00 p.m. ET, Corporate Presentation
    • The Morgan Stanley 19th Annual Global Healthcare Conference
      • Monday, September 13, 2021 at 11:45 a.m. ET, Fireside Chat

    Live webcasts of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at http://investors.alector.com. Replays of the webcasts will be available on the Alector website for 30 days following the presentation dates.

    About Alector

    Alector 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 the 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. This scientific approach is also the basis for the company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

    Alector Contacts

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Laura Perry/Eric Kasper

    Argot Partners

    212.600.1902

    alector@argotpartners.com

     



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  4. Presented twelve-month data from ongoing AL001 open-label Phase 2 study in FTD-GRN at the 2021 Alzheimer's Association International Conference (AAIC)

    Announced global collaboration with GSK to co-develop and co-commercialize progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases

    SOUTH SAN FRANCISCO, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported financial results for the second quarter 2021. As of June 30, 2021, Alector's cash, cash equivalents and investments totaled $319.6 million.

    "With the recent presentation of encouraging Phase 2…

    Presented twelve-month data from ongoing AL001 open-label Phase 2 study in FTD-GRN at the 2021 Alzheimer's Association International Conference (AAIC)

    Announced global collaboration with GSK to co-develop and co-commercialize progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases

    SOUTH SAN FRANCISCO, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported financial results for the second quarter 2021. As of June 30, 2021, Alector's cash, cash equivalents and investments totaled $319.6 million.

    "With the recent presentation of encouraging Phase 2 data for our lead program, AL001 in people with FTD-GRN, at the Alzheimer's Association International Conference and our announcement of a significant collaboration with GlaxoSmithKline to expand and accelerate the development of AL001 and AL101, we move much closer to realizing the vast potential of our progranulin franchise programs," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "Our earlier-stage pipeline is also steadily progressing and based on our immuno-neurology expertise and insights into human genetics, we continue working to advance new programs to the clinic, all with the aim of halting the degeneration associated with serious neurological disease."

    Clinical and Corporate Updates

    Progranulin Franchise Portfolio

    • Twelve-month data from up to twelve patients with frontotemporal dementia with a progranulin mutation (FTD-GRN) from the open-label INFRONT-2 Phase 2 clinical trial of AL001 were presented at the 2021 Alzheimer's Association International Conference (AAIC).
      • Once monthly treatment with 60mg/kg of AL001 was shown to have a favorable safety profile and resulted in sustained elevation of progranulin to normal levels for greater than one year.
      • Clinical outcome assessments of AL001-treated patients showed slowing of clinical progression by 47% compared to a matched control cohort of participants from the Genetic FTD Initiative (GENFI2). Additionally, multiple disease-relevant biomarkers of lysosomal function, complement activation and neuronal health trended toward normalization or remained stable, suggesting that treatment with AL001 may slow disease progression. (1)



    • Alector and GlaxoSmithKline (GSK) entered into a global collaboration to co-develop and co-commercialize AL001 and AL101 for the treatment of neurodegenerative diseases, including FTD-GRN, as well as other forms of frontotemporal dementia, amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease.

      • The collaboration brings together Alector's leading immuno-neurology expertise with GSK's commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of AL001 and AL101 into large indications.
      • Under the terms of the agreement, Alector will receive $700 million in upfront payments. Alector will also be eligible for up to $1.5 billion in potential development, regulatory and commercial launch milestone payments, as well as profit-sharing in the U.S. and royalties on any ex-U.S. sales.



    • Alector is actively enrolling the Phase 3 INFRONT-3 pivotal clinical study of AL001 in at-risk and symptomatic carriers of frontotemporal dementia with a progranulin mutation. An ongoing Phase 2 study in frontotemporal dementia includes a cohort of patients with a C9orf72 mutation, and there are plans to begin testing AL001 in amyotrophic lateral sclerosis (ALS) patients with a C9orf72 mutation in the second half of 2021. AL101, Alector's second progranulin-elevating monoclonal antibody, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers.

    Alzheimer's Disease Portfolio

    • Two posters were presented at the 2021 AAIC for Alector's AL002 program targeting TREM2. TREM2 loss of function is associated with a three-fold increase in the risk of developing Alzheimer's disease (2). AL002 is Alector's first-in-class anti-TREM2 monoclonal antibody that is being developed in collaboration with AbbVie in a global Phase 2 study.
      • The first poster detailed results of the AL002 Phase 1 study in healthy volunteers. AL002 was generally well tolerated and demonstrated dose-dependent and robust target engagement in the brain.
      • A second poster reviewed the study design of the ongoing Phase 2 INVOKE-2 trial in people with early Alzheimer's disease. The global, multi-center, double-blind Phase 2 clinical trial is enrolling approximately 265 patients randomized to receive AL002 or placebo. The study is designed to investigate the efficacy and safety of AL002 for the treatment of Alzheimer's disease.
    • Data from the Phase 1b study evaluating AL003 in participants with Alzheimer's disease is expected in the second half of 2021.  The AL003 clinical development program is being developed in collaboration with AbbVie.

    Second Quarter 2021 Financial Results

    Revenue. Collaboration revenue for the quarter ended June 30, 2021, was $6.6 million, compared to $3.2 million for the same period in 2020. Revenue is recognized as the program costs are incurred by measuring actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Changes in estimates for revenue recognized over time are recognized on a cumulative basis.

    R&D Expenses. Total research and development expenses for the quarter ended June 30, 2021, were $47.8 million, compared to $34.1 million for the same period in 2020. This change was mainly driven by an increase in expenses to support advancement of several clinical and preclinical programs, as well as in increase in personnel-related expenses

    G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2021, were $14.1 million, compared to $15.7 million for the same period in 2020. This decrease was primarily due to reduced legal fees associated with the conclusion of our arbitration proceedings for certain intellectual property matters.

    Net Loss. For the quarter ended June 30, 2021, Alector reported a net loss of $55.1 million, compared to a net loss of $45.3 million for the same period in 2020.

    Cash Position. Cash, cash equivalents, and marketable securities were $319.6 million as of June 30, 2021.

    Updated Cash guidance. Based on the company's cash position as of the end of the second quarter, combined with the anticipated net proceeds expected from the GSK collaboration beginning in the third quarter of 2021, Alector anticipates sufficient cash to fund currently planned operations into mid-2024.

    About Alector

    Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company 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 the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company's immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. This scientific approach is also the basis for the Company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

    (1) Paul, Robert, et al, "AAIC 2021" "Twelve month Results from the INFRONT-2 Phase 2 Open-label Clinical Study of AL001 in Frontotemporal Dementia Patients with a Progranulin Mutation (FTD-GRN)"

    (2) Guerreiro, et al. "TREM2 Variants in Alzheimer's Disease" NEJM. 2013; and Jonsson, et al. "Variant of TREM2 associated with the risk of Alzheimer's disease" NEJM 2013

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to market conditions, Alector and its business as set forth in our Quarterly Report on Form 10-Q, as filed on August 3, 2021 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,
      2021 2020
           
    Cash, cash equivalents, and marketable securities $319,570 $413,308
    Total assets  397,113  488,251
    Total current liabilities (excluding deferred revenue)  48,976  44,202
    Deferred revenue (including current portion)  121,625  132,303
    Total liabilities  212,598  220,721
    Total stockholders' equity  184,515  267,530

    Consolidated Statement of Operations Data

    (in thousands, except share and per share data)

      Three Months Ended

    June 30,
      Six Months Ended

    June 30,

     
      2021  2020

      2021  2020

     
    Collaboration revenue$6,568  $3,170  $10,678  $10,341 
    Operating expenses:               
    Research and development 47,818   34,062   93,551   68,667 
    General and administrative 14,075   15,697   25,087   30,341 
    Total operating expenses 61,893   49,759   118,638   99,008 
    Loss from operations (55,325)  (46,589)  (107,960)  (88,667)
    Other income, net 178   1,263   642   3,322 
    Net loss$(55,147) $(45,326) $(107,318) $(85,435)
    Net loss per share, basic and diluted$(0.69) $(0.58) $(1.35) $(1.11)
    Shares used in computing net loss per share, basic and diluted 79,790,036   78,415,195   79,598,188   76,617,938 
     

    Alector Contacts

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Joseph Rayne

    Argot Partners

    212.600.1902

    joseph@argotpartners.com



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  5. AL001 Successfully Restored Progranulin to Normal Levels in FTD-GRN Patients

    Treatment with AL001 Slowed Clinical Progression by 47% Based on the CDR® plus NACC FTLD-SB Scale Relative to GENFI2 Matched Control Cohort

    Consistent Trends toward Normalization or Stabilization in
    Multiple Disease Biomarkers Observed with AL001 Treatment

    Data from Phase 2 Study Presented at Alzheimer's Association International Conference; Management to Host Webcast to Review Results Today at 1:00 p.m. ET

    DENVER, July 29, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, presented promising results from the company's INFRONT-2 Phase 2 clinical trial of AL001 at the Alzheimer's Association…

    AL001 Successfully Restored Progranulin to Normal Levels in FTD-GRN Patients

    Treatment with AL001 Slowed Clinical Progression by 47% Based on the CDR® plus NACC FTLD-SB Scale Relative to GENFI2 Matched Control Cohort

    Consistent Trends toward Normalization or Stabilization in

    Multiple Disease Biomarkers Observed with AL001 Treatment

    Data from Phase 2 Study Presented at Alzheimer's Association International Conference; Management to Host Webcast to Review Results Today at 1:00 p.m. ET

    DENVER, July 29, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, presented promising results from the company's INFRONT-2 Phase 2 clinical trial of AL001 at the Alzheimer's Association International Conference (AAIC 2021). AL001 is initially being developed for the treatment of adults at risk for or with symptomatic frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is a potential first-in-class monoclonal antibody designed to elevate progranulin, a key regulator of immune activity in the brain. Decreased progranulin levels due to genetic mutations are a known cause of frontotemporal dementia (FTD), a rare, rapidly progressing neurodegenerative disease that is the most common form of dementia for people under the age of 60.

    Data presented today focused on up to twelve symptomatic FTD-GRN patients treated over twelve months in an open-label study designed to assess safety, pharmacokinetics and pharmacodynamics, exploratory biomarkers and efficacy. AL001 showed a favorable safety profile and rapidly restored progranulin levels to normal ranges in both plasma and cerebrospinal fluid (CSF) for the duration of treatment. While the INFRONT-2 Phase 2 study was not designed to demonstrate clinical benefit, clinical outcome assessments using the CDR® plus NACC FTLD-SB scale found that AL001 treatment slowed clinical progression by 47% compared to a matched control cohort of participants from the Genetic FTD Initiative (GENFI2)(1). Additionally, multiple disease-relevant biomarkers of lysosomal function, complement activation and neuronal health trended toward normalization or remained stable.

    "Though this is a small open-label study, the totality of the data presented from the INFRONT-2 Phase 2 study paint an encouraging picture of AL001's potential to slow disease progression in patients with FTD, a devastating disease for which there are currently no approved treatment options," said Robert Paul, M.D., Ph.D., Alector's Chief Medical Officer. "Chronic treatment with AL001 demonstrated durable, on-target activity with a complete reversal of the progranulin deficiency that is causing disease. The effect of AL001 treatment on clinical disease progression, and consistent improvements observed across diverse biomarkers, strengthen our confidence that AL001 is working as designed. We look forward to building upon these data in our Phase 3 study of AL001 in FTD-GRN mutation carriers and other planned studies in patient populations in which progranulin deficiencies are a known risk factor."

    Alector is actively enrolling the INFRONT-3 Phase 3 pivotal clinical study of AL001 in at-risk and symptomatic carriers of the progranulin mutation causative of FTD. The global randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of AL001 in inhibiting disease progression with the primary endpoint, CDR® plus NACC FTLD-SB scale. AL001 is also being studied in FTD patients with a C9orf72 mutation, with plans to begin testing AL001 in C9orf72 amyotrophic lateral sclerosis (ALS) in the second half of 2021.

    INFRONT-2 Phase 2 Clinical Trial Results

    The open-label INFRONT-2 Phase 2 study was designed primarily to assess the safety and tolerability of chronic dosing of AL001 over 96 weeks. INFRONT-2 included three cohorts of FTD patients: asymptomatic FTD-GRN patients, symptomatic FTD-GRN patients and FTD-C9orf72 patients. Biomarker and clinical results presented today focused on the symptomatic FTD-GRN cohort and included 12-month data for up to twelve patients who received 60mg/kg of AL001 every four weeks. As of the data cut, nine FTD-GRN patients had completed twelve months of treatment, and between seven and nine patients were able to complete all assessments.

    Safety data was reported across all three cohorts (N=27) who received a median of 15 doses of AL001. AL001 showed a favorable safety profile in the Phase 2 study. Six of the 27 patients reported mild treatment-related adverse events (AEs). The most common AEs observed on study in more than two patients were falls (5/27, 18.5%) and rash (3/27, 11.1%). Three patients in the FTD-GRN cohort experienced serious AEs, but none of these were attributed to treatment with AL001.

    Among the symptomatic FTD-GRN cohort, AL001 treatment resulted in rapid and sustained 2-2.5-fold elevations of progranulin comparable to normal levels from an age-matched procured control group of healthy volunteers.

    Table 1: Progranulin Levels from Baseline to 12 months with AL001 Treatment (ng/mL)
    PlasmaCSF
     AL001



    Age-matched

    procured control

    (N=46)
     AL001



    Age-matched

    procured control


    (N=44)
     Baseline (N=12)40.3 (2.64)64.6 – 196.0



    Baseline (N=10)2.3 (0.22)3.48 – 7.06



     25 weeks (N=9)99.0 (4.94)25 weeks (N=9)4.4 (0.43)
     49 weeks (N=7)86.8 (3.72)49 weeks (N=7)4.2 (0.54)

    CSF: cerebrospinal fluid, (): standard error of the mean.

    Representative biomarkers associated with progranulin deficiencies measuring lysosomal function (CTSD and LAMP1) and complement activation (C1QB) were elevated in FTD-GRN patients at baseline compared to an age-matched procured control group, indicative of a disease state. AL001 treatment resulted in a time-dependent and durable decreases over twelve months to levels seen in age-matched controls, suggesting that AL001 restores normal lysosome and complement function in these patients.

    Table 2: CSF Lysosomal and Complement System Biomarkers of Disease Activity from Baseline to

    12 months with AL001 Treatment (fmol/L)
     Biomarker AL001

    Baseline

    (N=9)
    AL001

    6 months

    (N=8)
    AL001

    12 months

    (N=8)
    Age-matched

    procured control

    (N=44)
     CTSD 5.2 (1.16)3.8 (0.57)3.1 (0.21)3.4 (0.08)
     LAMP10.6 (0.12)0.4 (0.06)0.4 (0.043)0.4 (0.01)
     C1QB0.7 (0.12)0.6 (0.07)0.5 (0.02)0.5 (0.02)

    CTSD: cathepsin D, LAMP1: lysosomal-associated membrane protein 1, C1QB: complement C1q B chain, CSF: cerebrospinal fluid,

    (): standard error of the mean.

    Neuronal degeneration was assessed by measuring neurofilament light chain (NfL) in the plasma and CSF, and by measuring brain atrophy via volumetric magnetic resonance imaging (vMRI). NfL showed within-patient variability in patients and over time, with mean levels stable at 49 weeks compared to baseline.

    Table 3: NfL Levels from Baseline to 12 months with AL001 Treatment
    Plasma (pg/mL)CSF (ng/mL)
    Baseline

    (N=12)
    25 weeks

    (N=9)
    49 weeks

    (N=7)
    Baseline

    (N=11)
    25 weeks

    (N=9)
    49 weeks

    (N=9)
    62.8 (13.57)67.5 (24.51)46.3 (12.93)7.3 (1.51)7.7 (1.63)6.5 (1.29)

    NfL: neurofilament light chain protein, CSF: cerebrospinal fluid, (): standard error of the mean.

    Volume changes of the whole brain, the frontotemporal cortex and the ventricles were measured over one year and compared to a matched control cohort (N=7) developed from participants in the GENFI2 patient registry. Treatment with AL001 resulted in a greater than 10% difference in the atrophy rates in favor of AL001 for the whole brain and frontotemporal cortex measures, and an approximately 50% reduction in ventricular enlargement.

    Table 4: Percent Volume Changes Observed in the Brain over 12 Months Using Volumetric MRI with

    AL001 Treatment vs. GENFI2 Matched Control
     GENFI2

    control cohort

    (N=7*)
    AL001

    (N=8*)
    Difference in relative

    atrophy rates
     Whole brain-4.6 (0.93)-4.1 (0.93)10.9%
     Frontotemporal cortex-1.8 (0.51)-1.5 (0.54)16.7%
     Ventricles25.6 (14.6)12.9 (4.99)49.6%

    (): standard error of the mean. *N=8 for whole brain; N=7 for frontotemporal (FT) cortex and ventricles.

    One GENFI2 control cohort patient with a 2.58% annual volume increase in the frontotemporal cortex is excluded as an image processing outlier.

    The potential clinical benefit of AL001 in FTD-GRN patients was measured using the CDR® plus NACC FTLD-SB scale, a standard FTD clinical rating instrument that assesses cognitive, functional, behavioral and language impairments over time, and which is also the primary endpoint of Alector's ongoing Phase 3 study of AL001 for the treatment of FTD-GRN.

    Treatment with AL001 showed a 47% slowing of clinical progression among the INFRONT-2 patients relative to matched GENFI2 controls. The CDR® plus NACC FTLD-SB scores in the GENFI2 matched control group (N=10), showed an annual increase of 6.4 points from baseline over one year, indicating rapid disease progression. In contrast, the annual increase in the AL001 cohort (N=12) was only 3.4 points over one year, a 3.0-point difference in annual change.

    Conference Call Information

    Alector management will host a conference call to review and discuss data presented at AAIC 2021 today at 1:00 p.m. ET. Analysts and investors are invited to participate in the conference call by dialing (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 5267479.  The live webcast can be accessed on the investor page of Alector's website at investors.alector.com where a copy of the AAIC 2021 presentations have been posted. A replay of the webcast will be available on Alector's website approximately two hours after the completion of the event and will be archived for up to 30 days.

    About the Phase 3 INFRONT-3 Clinical Trial

    The pivotal Phase 3 INFRONT-3 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of AL001 in treating symptomatic patients and at-risk people with FTD due to a progranulin gene mutation (FTD-GRN). The study aims to enroll up to 180 FTD-GRN mutation carriers across approximately 50 sites in the United States, Europe and the Asia Pacific Region. Participants will be randomized to receive AL001 or placebo intravenously every four weeks for the duration of the 96-week study and will be given the option to continue receiving treatment in an optional open-label extension study after the 96-week treatment period. The primary endpoint of the pivotal Phase 3 trial is the effect of AL001 on clinical decline by utilizing the CDR® plus NACC FTLD-SB scale, which evaluates clinical impairments in behavior, language, orientation, memory, judgment, and functional activities in trial participants. In addition, the trial will assess secondary clinical endpoints of clinical status, cognition and function, multiple biomarkers and safety.

    About Frontotemporal Dementia

    FTD is a rare neurodegenerative disease but it is the most common form of dementia for people under the age of 60.  It affects an estimated 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are multiple heritable forms of frontotemporal dementia, and FTD-GRN patients represent 5% to 10% of all people with FTD. Patients with FTD frequently develop symptoms such as behavioral changes, lapses in judgment, and diminished language skills when they are in their 40's and 50's with the disease running its course in 7-10 years. There are currently no FDA-approved treatment options available for any form of frontotemporal dementia.

    About Alector

    Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The company 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 the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector's immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. This scientific approach is also the basis for the company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

    (1) The GENFI2 historic matched control group was selected on a blinded basis without access to clinical longitudinal data based on a propensity score matching technique combined with clinical adjudication of select baseline characteristics (NfL plasma levels, age, diagnosis and gender).

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of AL001; the expected timing of reporting future data from the AL001 clinical trial; the potential benefits of AL001 or Alector's (the Company) other product candidates; and statements by the Company's chief medical officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Alector's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: the Company's plans relating to the development and manufacturing of its product candidates and research programs; the ability of the Company's clinical trials to demonstrate safety and efficacy of its product candidates, and other positive results; the timing and focus of the Company's future clinical trials, and the reporting of data from those trials; the Company's plans relating to commercializing its product candidates, if approved, including the geographic areas of focus and sales strategy; the expected potential benefits of strategic collaborations with third parties and the Company's ability to attract collaborators with development, regulatory and commercialization expertise; the Company's estimates of the number of patients in the United States who suffer from the diseases it is targeting and the number of patients that will enroll in its clinical trials; the size of the market opportunity for the Company's product candidates in each of the diseases it is targeting; the Company's ability to expand its product candidates into additional indications and patient populations; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy, and therapeutic effects of the Company's product candidates; the timing or likelihood of regulatory filings and approvals, including the Company's expectation to seek special designations, such as orphan drug designation, for its product candidates for various diseases; the Company's ability to obtain and maintain regulatory approval of its product candidates; the Company's plans relating to the further development and manufacturing of its product candidates, including additional indications that it may pursue; existing regulations and regulatory developments in the United States and other jurisdictions; the Company's continued reliance on third parties to conduct additional clinical trials of its product candidates, and for the manufacture of its product candidates for preclinical studies and clinical trials; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Alector's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 5, 2021, and Alector's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and Alector assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Alector Contacts

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Joseph Rayne

    Argot Partners

    212.600.1902

    joseph@argotpartners.com



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