Alector(ALEC)
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Alector Stock Plummets 63% in a Month: Here's What You Need to Know
ZACKS· 2025-11-18 16:36
Core Viewpoint - Alector's shares have dropped 62.5% in the past month due to the failure of its late-stage study for latozinemab in treating frontotemporal dementia caused by a progranulin gene mutation [1] Group 1: Study Results - The phase III INFRONT-3 study of latozinemab did not meet its primary endpoint of slowing disease progression in symptomatic and at-risk FTD-GRN patients, as measured by the CDR plus NACC FTLD-SB scale [2] - Despite missing clinical endpoints, the therapy showed a statistically significant effect on the biomarker endpoint of plasma progranulin concentrations [2] - No treatment-related improvements were observed in secondary and exploratory endpoints, including fluid biomarkers and volumetric magnetic resonance imaging [3] Group 2: Company Actions - Following the disappointing study results, Alector has decided to discontinue the open-label extension of the INFRONT-3 study and a continuation study for latozinemab [8] - The company is reducing its workforce by approximately 49% to focus resources on priority programs and maintain progress across its core pipeline [8] Group 3: Pipeline Focus - Alector is shifting its focus to its remaining clinical candidate, nivisnebart, which is being evaluated in a phase II PROGRESS-AD study for early-stage Alzheimer's disease [9] - Nivisnebart is a human monoclonal antibody designed to elevate PGRN concentrations in the brain, differing from latozinemab in pharmacokinetic and pharmacodynamic characteristics [10] - The PROGRESS-AD study is expected to complete enrollment and finish by 2026, with an independent interim analysis scheduled for the first half of 2026 [10] Group 4: Collaboration and Financials - Alector and GSK entered a global collaboration agreement in 2021 to develop progranulin-elevating monoclonal antibodies, with profits and losses split evenly in the U.S. and Alector eligible for royalties outside the U.S. [12]
ALEC Investors Have Opportunity to Join Alector, Inc. Fraud Investigation with the Schall Law Firm
Businesswire· 2025-11-12 03:43
Core Viewpoint - Alector, Inc. is under investigation by the Schall Law Firm for potential violations of securities laws following disappointing results from a clinical trial, which led to a significant drop in its stock price [2][3]. Group 1: Investigation Details - The Schall Law Firm is investigating claims on behalf of Alector investors regarding false or misleading statements made by the company [2]. - Alector's press release on October 21, 2025, revealed that its drug candidate, latozinemab (AL001), failed to meet the primary endpoint in a Phase 3 clinical trial for frontotemporal dementia, resulting in a nearly 50% drop in share price the following day [2][3]. Group 2: Legal Representation - The Schall Law Firm specializes in securities class action lawsuits and is encouraging affected shareholders to participate in the investigation [3]. - Investors can contact the Schall Law Firm for a free discussion about their rights [3].
Alector (ALEC) Reports Q3 Loss, Beats Revenue Estimates
ZACKS· 2025-11-07 00:26
Core Insights - Alector reported a quarterly loss of $0.34 per share, better than the Zacks Consensus Estimate of a loss of $0.42, marking an earnings surprise of +19.05% [1] - The company generated revenues of $3.26 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 24.19%, but down from $15.34 million year-over-year [2] - Alector's stock has underperformed, losing approximately 33.6% since the beginning of the year, while the S&P 500 has gained 15.6% [3] Financial Performance - Over the last four quarters, Alector has surpassed consensus EPS estimates four times and topped revenue estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.41 on revenues of $3 million, and for the current fiscal year, it is -$1.57 on revenues of $17.15 million [7] Industry Context - Alector operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 41% of over 250 Zacks industries [8] - The industry’s performance can significantly impact Alector's stock performance, with research indicating that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8] Future Outlook - The sustainability of Alector's stock price movement will largely depend on management's commentary during the earnings call and future earnings expectations [3][4] - The estimate revisions trend for Alector was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6]
Alector(ALEC) - 2025 Q3 - Quarterly Report
2025-11-06 21:17
Financial Performance - The company reported net losses of $34.7 million and $105.7 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $934.8 million as of the same date[93]. - Net loss for the three months ended September 30, 2025, was $34.7 million, an improvement of $7.6 million compared to a net loss of $42.2 million in the same period of 2024[108]. - For the nine months ended September 30, 2025, cash used in operating activities was $142.3 million, primarily due to a net loss of $105.7 million[130]. - For the nine months ended September 30, 2024, cash used in operating activities was $174.9 million, with a net loss of $117.0 million[131]. Revenue and Expenses - The company has not generated any product or royalty revenue from product sales and does not expect to do so until successful development and marketing approval of product candidates[93]. - Collaboration revenue decreased to $3.3 million for the three months ended September 30, 2025, down from $15.3 million in the same period of 2024, a decline of $12.0 million[109]. - For the nine months ended September 30, 2025, collaboration revenue was $14.8 million, down from $46.3 million in 2024, a decrease of $31.5 million[116]. - Research and development expenses were $29.4 million for the three months ended September 30, 2025, compared to $48.0 million for the same period in 2024, a decrease of $18.6 million[110]. - Research and development expenses for the nine months ended September 30, 2025, were $90.6 million, down from $139.5 million in 2024, a decrease of $48.9 million[117]. - Total operating expenses for the nine months ended September 30, 2025, were $131.2 million, compared to $184.1 million in 2024, a decrease of $52.8 million[115]. - General and administrative expenses decreased to $11.5 million for the three months ended September 30, 2025, from $15.8 million in 2024, a reduction of $4.3 million[112]. Cash and Financing - The company’s cash, cash equivalents, and marketable securities totaled $291.1 million as of September 30, 2025, providing runway through 2027[94]. - The company expects to fund operations into the second half of 2027 based on current cash resources, but may seek additional financing opportunistically[124]. - The company entered into an at-the-market sales agreement to sell up to $125 million of common stock, having issued 5,415,162 shares for approximately $14.7 million in net proceeds as of September 30, 2025[126]. - Cash provided by investing activities for the same period was $171.0 million, mainly from maturities of marketable securities totaling $359.0 million[132]. - Cash provided by financing activities was $14.8 million, primarily from proceeds from the sale of securities under a sales agreement with TD Securities[134]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $291.1 million[138]. - Approximately $2.8 million of cash exceeded FDIC insurance limits as of September 30, 2025[139]. Development and Research - The company plans to submit an Investigational New Drug (IND) application for the AL137 program in 2026 and for the AL050 program in 2027[87][89]. - The company is co-developing nivisnebart with GSK for early Alzheimer's disease, with a Phase 2 trial completion expected in 2026[83]. - The company’s research and development expenses are primarily related to the discovery and development of product candidates, including nivisnebart[100][101]. - The company is advancing its proprietary Alector Brain Carrier (ABC) technology to enhance therapeutic delivery across the blood-brain barrier[76][85]. Agreements and Deferred Revenue - Under the GSK Agreement, the company received $700 million in upfront payments, with potential additional milestone payments of up to $1.5 billion[96]. - The deferred revenue balance related to the GSK Agreement was $179.0 million as of September 30, 2025, expected to be recognized over the research and development period[99]. Workforce and Operational Changes - The company has committed to a workforce reduction of approximately 47% following the results of the Phase 3 INFRONT-3 clinical trial[94]. Risk Factors - The company has not had a formal hedging program for foreign currency, and foreign currency transaction gains and losses have not been material to financial statements[140]. - The company is exposed to interest rate risks but maintains a portfolio of high credit quality securities to preserve capital[137]. - A 100 basis point change in interest rates would result in a fair value change of approximately $0.8 million due to the company's interest-earning instruments[138].
Alector(ALEC) - 2025 Q3 - Quarterly Results
2025-11-06 21:12
Clinical Trial Results - The Company announced results from its Phase 3 INFRONT-3 clinical trial, which included a preliminary estimate of cash, cash equivalents, and short-term investments as of September 30, 2025[6]. - The Company is discontinuing the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab[8]. - The Company issued a press release on October 21, 2025, detailing the results of the Phase 3 INFRONT-3 clinical trial and the workforce reduction plan[12]. Workforce Reduction - The Company plans to reduce its workforce by approximately 49%, impacting about 75 employees, to align resources with strategic priorities[8]. - Total incremental restructuring charges associated with the reduction in force are expected to be approximately $7.7 million[9]. - The reduction in force is expected to be completed during the first half of 2026[9]. - The Company may incur additional costs related to the workforce reduction that are not currently contemplated[9]. - Forward-looking statements regarding the Company's business strategy and expected impacts of the workforce reduction are subject to risks and uncertainties[14]. Executive Changes - Dr. Sara Kenkare-Mitra, President and Head of Research and Development, will resign effective December 22, 2025[10]. - Dr. Kenkare-Mitra will receive a lump-sum cash payment equal to nine months of her annual base salary and 50% of her annual bonus target[11].
Alector Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 21:05
Core Insights - Alector, Inc. is advancing its innovative drug candidates targeting neurodegenerative diseases, focusing on its Alector Brain Carrier (ABC) platform for enhanced delivery of therapeutics to the brain [2][3] Financial Overview - As of September 30, 2025, Alector reported cash, cash equivalents, and investments totaling $291.1 million, which is expected to fund operations through 2027 [15] - Collaboration revenue for Q3 2025 was $3.3 million, a significant decrease from $15.3 million in Q3 2024, primarily due to the completion of performance obligations related to previous programs [9] - Total research and development expenses for Q3 2025 were $29.4 million, down from $48.0 million in Q3 2024, attributed to reduced spending on specific programs and workforce reductions [10] - General and administrative expenses for Q3 2025 were $11.5 million, compared to $15.8 million in Q3 2024, reflecting cost-saving measures [13] - A net loss of $34.7 million was reported for Q3 2025, an improvement from a net loss of $42.2 million in Q3 2024 [14] Drug Development Pipeline - Alector has selected AL137 as the lead candidate for its ABC-enabled anti-amyloid beta antibody in Alzheimer's disease, with an IND filing targeted for 2026 [4] - The company is also advancing AL050, an ABC-enabled GCase enzyme replacement therapy for Parkinson's disease, with an IND submission planned for 2027 [11] - The ABC platform is designed to facilitate the delivery of antibodies, enzymes, and siRNA to the brain, demonstrating robust brain penetration and favorable safety profiles [2][3] Clinical Trials and Collaborations - The PROGRESS-AD Phase 2 clinical trial for nivisnebart (AL101) in early Alzheimer's disease is ongoing, with an independent interim analysis planned for the first half of 2026 [12] - Alector and GSK are collaborating on the development of nivisnebart, which aims to elevate progranulin concentrations in the brain [12][6] - The INFRONT-3 Phase 3 trial for latozinemab did not show clinical benefit, leading to the discontinuation of further studies for this candidate [7] Strategic Focus - Alector has implemented a workforce reduction of approximately 47% to concentrate resources on high-priority programs and extend its cash runway [8] - The company continues to anticipate collaboration revenue between $13 million and $18 million for the year, with total R&D expenses projected between $130 million and $140 million [16]
Alector Announces Topline Results from Phase 3 INFRONT-3 Clinical Trial Evaluating Latozinemab
Yahoo Finance· 2025-10-31 09:42
Core Insights - Alector Inc. is highlighted as a promising investment opportunity under $3, particularly following the announcement of topline results from the Phase 3 INFRONT-3 clinical trial for its drug latozinemab (AL001) targeting frontotemporal dementia due to a progranulin gene mutation [1][4] Clinical Trial Results - The INFRONT-3 trial, a 96-week double-blind study conducted in collaboration with GSK, did not achieve its primary endpoint of slowing the progression of frontotemporal dementia as measured by the Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes [2][3] Future Developments - Alector is also involved in the PROGRESS-AD trial, a global 76-week Phase 2 study evaluating nivisnebart (AL101/GSK4527226) for early Alzheimer's disease, with enrollment completed in April 2025 and trial completion expected in 2026, including an independent interim analysis planned for H1 2026 [3]
Alector (ALEC) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
ZACKS· 2025-10-29 15:01
Core Viewpoint - The market anticipates Alector (ALEC) will report a year-over-year increase in earnings despite lower revenues, with actual results being crucial for stock price movement [1][2]. Company Summary - Alector is expected to report a quarterly loss of $0.42 per share, reflecting a year-over-year change of +2.3% [3]. - Revenues are projected to be $2.63 million, down 82.9% from the same quarter last year [3]. - The consensus EPS estimate has been revised 3.13% lower in the last 30 days, indicating a reassessment by analysts [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that Alector's Most Accurate Estimate is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -5.77% [12]. - Alector currently holds a Zacks Rank of 3, making it challenging to predict an earnings beat conclusively [12]. Historical Performance - In the last reported quarter, Alector was expected to post a loss of $0.45 per share but actually reported a loss of -$0.30, achieving a surprise of +33.33% [13]. - Over the past four quarters, Alector has beaten consensus EPS estimates four times [14]. Industry Context - Another company in the same industry, AC Immune (ACIU), is expected to report a loss of $0.22 per share, indicating a year-over-year change of -466.7% [18]. - AC Immune's revenues are expected to be $1.52 million, down 94.8% from the previous year [18]. - The consensus EPS estimate for AC Immune has been revised 4.3% higher in the last 30 days, but it also has a negative Earnings ESP of -4.55% [19][20].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Alector, Inc. - ALEC
Prnewswire· 2025-10-28 14:00
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Alector, Inc. following disappointing clinical trial results for its drug, latozinemab, which did not meet primary endpoints [1][2]. Group 1: Company Overview - Alector, Inc. is a biotechnology company focused on developing therapies for neurodegenerative diseases [2]. - The company recently announced results from the Phase 3 INFRONT-3 clinical trial for latozinemab, which targets frontotemporal dementia due to a progranulin gene mutation [2]. Group 2: Clinical Trial Results - The Phase 3 clinical trial results indicated that latozinemab failed to meet its clinical co-primary endpoint of slowing the progression of frontotemporal dementia [2]. - Secondary and exploratory endpoints, including fluid biomarkers and volumetric magnetic resonance imaging (vMRI), showed no treatment-related effects [2]. Group 3: Market Reaction - Following the announcement of the trial results, Alector's stock price dropped by $1.60 per share, representing a decline of 49.84%, closing at $1.61 per share on October 22, 2025 [2].
Clinical Failure Halts Alector's Dementia Program, Company Reduces Workforce
Benzinga· 2025-10-22 16:07
Core Insights - Alector, Inc. announced results from the Phase 3 INFRONT-3 trial for latozinemab (AL001) targeting frontotemporal dementia caused by a progranulin gene mutation, which did not meet its primary clinical endpoint [1][2] Trial Results - The 96-week study did not achieve the co-primary endpoint of slowing FTD-GRN progression as measured by the Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes [2] - Although there was a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin concentrations, secondary and exploratory endpoints showed no treatment-related effects on FTD-GRN [3] - Preliminary safety data did not indicate major safety concerns, but further analysis is ongoing [3] Future Plans - The open-label extension of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued based on the trial results [4] - Alector is collaborating with GSK on nivisnebart (AL101/GSK4527226) in a 76-week Phase 2 trial for early Alzheimer's disease, with trial completion expected in 2026 [5] Financial Outlook - As of September 30, 2025, Alector has approximately $291.1 million in cash and equivalents, expected to provide financial runway through 2027 [6] Analyst Commentary - William Blair downgraded Alector from Outperform to Market Perform, with analyst Myles Minter removing latozinemab from the FTD-GRN opportunity [7] - Despite observing plasma and CNS PGRN elevations to normal levels, the link between PGRN insufficiency and FTD-GRN remains uncertain [7] Stock Performance - Following the announcement, Alector shares fell by 51.09% to $1.57, nearing a 52-week low of $0.87 [8]