SOUTH SAN FRANCISCO, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC) and GSK plc (NYSE:GSK) today announced that the first patient has been dosed in PROGRESS-AD, the global Phase 2 clinical trial of AL101/GSK4527226 in patients with early Alzheimer's disease (AD), including mild cognitive impairment and mild dementia due to AD. AL101 is an investigational human monoclonal antibody designed to block and downregulate the sortilin receptor to elevate the level of progranulin in the brain ...

Core Insights - Latozinemab has received Breakthrough Therapy Designation from the FDA for the treatment of frontotemporal dementia with a progranulin gene mutation (FTD-GRN), marking it as the first investigational medicine to achieve this status for FTD-GRN [1][2] - The drug is currently being studied in the pivotal INFRONT-3 Phase 3 clinical trial, which reached its target enrollment in October 2023 [2] - Alector, in collaboration with GSK, aims to address the unmet medical need for FTD-GRN, a serious condition with no FDA-approved treatment options available [2][4] Company Overview - Alector is a clinical-stage biotechnology company focused on immuno-neurology, targeting immune dysfunction as a root cause of neurodegenerative diseases [6] - The company has developed a portfolio of programs aimed at repairing genetic mutations affecting the brain's immune system [6] - Alector is headquartered in South San Francisco, California [7] Collaboration with GSK - Alector entered into a collaboration and license agreement with GSK in July 2021, receiving $700 million in upfront payments [5] - The agreement includes potential additional payments of up to $1.5 billion based on clinical development, regulatory, and commercial milestones [5] - Profits and losses from the commercialization of latozinemab and AL101 will be shared equally in the U.S., while Alector will receive double-digit tiered royalties outside the U.S. [5] Disease Context - Frontotemporal dementia (FTD) is a rare neurodegenerative disease and a leading cause of early onset dementia, affecting an estimated 50,000 to 60,000 people in the U.S. and approximately 110,000 in the European Union [4] - FTD patients with a progranulin gene mutation (FTD-GRN) represent 5% to 10% of all FTD cases, with symptoms typically manifesting in individuals in their 40s and 50s [4]

Core Viewpoint - Alector (ALEC) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Estimate Revisions - The Zacks Consensus Estimate for Alector indicates expected earnings of -$1.79 per share for the fiscal year ending December 2023, reflecting a year-over-year decline of 10.5% [5]. - Over the past three months, analysts have raised their earnings estimates for Alector by 17.3% [5]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with near-term stock price movements, as institutional investors adjust their valuations based on these estimates, leading to significant buying or selling activity [3]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [4]. - Alector's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for price appreciation in the near term [7].

Some of the worst and most deadly diseases affect our brains. In multiple sclerosis, the immune system “causes communication problems between your brain and the rest of your body,” preventing some victims from walking.” Brain cancer is often a quick killer, while Alzheimer’s, of course, causes victims to slowly lose their cognitive abilities and is always deadly. This means there is a large market for neuroscience stocks to address to help patients find relief.Schizophrenia, meanwhile, prevents victims from ...

SOUTH SAN FRANCISCO, Calif., Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced the closing of its underwritten public offering of shares of its common stock. Alector sold 10,869,566 shares of its common stock in the offering. Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock. The gross proceeds to Alector from the offering, before deducting u ...

fatido/E+ via Getty Images Alector, Inc. (NASDAQ:ALEC) has been able to complete enrollment of its phase 2 INVOKE-2 study, which is using AL002 for the treatment of patients with early-stage Alzheimer's Disease [AD]. With enrollment of this TREM2 activator complete, it expects to report results from this mid-stage study in Q4 of 2024. The thing is that not only is it possible that positive data could be achieved, but that the company is in the process of developing the most advanced TREM2 activator in c ...

SOUTH SAN FRANCISCO, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In connection with the proposed offering, Alector expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the total number of shares of its common stock offered in th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38792 Alector, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-2933343 (State or other jurisdiction ...

Financial Data and Key Metrics Changes - Collaboration revenue for Q2 2023 was $56.2 million, down from $79.9 million in Q2 2022 [24] - Total research and development expenses for Q2 2023 were $46.2 million, compared to $54.5 million in Q2 2022 [24] - Total general and administrative expenses for Q2 2023 were $13.6 million, down from $15.8 million in Q2 2022 [24] - Net income for Q2 2023 was $1.4 million or $0.02 per share, compared to $9.9 million or $0.12 per share in Q2 2022 [24] Business Line Data and Key Metrics Changes - The AL002 program is the most advanced TREM2 program in clinical development for Alzheimer's disease worldwide, with enrollment in the INVOKE-2 trial nearly complete [13][17] - The INFRONT-3 trial for latozinemab in frontotemporal dementia is also nearing completion of enrollment [20][21] Market Data and Key Metrics Changes - The company is advancing a broad portfolio of potential first-in-class treatments for brain disorders, addressing a significant public health challenge affecting over 1 billion people globally [10] Company Strategy and Development Direction - Alector is focused on pioneering immuno-neurology therapies that harness the immune system to treat neurodegenerative diseases [10] - The company is developing novel therapies in collaboration with GSK and AbbVie, aiming to enhance microglial activity and address conditions like Alzheimer's and frontotemporal dementia [11][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in neurodegenerative disease drug development and the potential for transformative therapies [9] - The company remains well-funded with a cash position of $630 million, providing a runway through 2025 [24] Other Important Information - Alector plans to complete enrollment in INVOKE-2 and INFRONT-3 trials in Q3 and Q4 2023, respectively [26] - The company is also developing ADP027 for Parkinson's disease, targeting the GPNMD gene [12][29] Q&A Session Summary Question: Additional details on GPNMD research program in Parkinson's disease - The GPNMD program targets a risk gene for Parkinson's disease and aims to modulate lysosomal function [29] Question: Timing for data readout for AL001 - Enrollment for the pivotal study is expected to complete in Q4 2023, with data anticipated in Q3 2025 [30][32] Question: Discussion on biomarkers in the Phase III trial - The primary analysis will focus on clinical treatment effects, supported by biomarker data [35] Question: Details on blood-brain barrier technology - The technology is versatile and can be tailored for different types of antibodies [37] Question: Effect size and powering of the FTD study - The clinical trial design remains unchanged, and the analysis will still provide sufficient power to detect a 40% treatment effect [39] Question: Clarification on TREM2 REA effects - Management is being cautious due to the different mechanism of action compared to existing therapies [43] Question: A-beta scanning in the trial - A-beta PET studies are included in the trial design [45] Question: Progression of asymptomatic patients - There is a smaller number of at-risk subjects, and they are not showing significant progression [47]

Financial Performance - The company reported a net income of $1.4 million for the three months ended June 30, 2023, compared to a net income of $9.9 million for the same period in 2022, indicating a decrease in profitability [71]. - The net loss for the six months ended June 30, 2023, was $44.5 million, compared to a net loss of $34.7 million for the same period in 2022, reflecting an increase in losses [71]. - Net income for Q2 2023 was $1.4 million, a decline of 86.1% compared to $9.9 million in Q2 2022 [82]. - For the six months ended June 30, 2023, collaboration revenue was $72.8 million, down 30.2% from $104.3 million in the same period of 2022 [90]. - Total operating expenses for the six months ended June 30, 2023, were $126.5 million, a decrease of 9.0% from $139.0 million in the same period of 2022 [89]. Revenue and Collaborations - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying on collaborations for funding [72]. - The balance of deferred revenue was $313.9 million as of June 30, 2023, related to the AbbVie and GSK Agreements [74]. - The company received a $17.8 million milestone payment in March 2023 from AbbVie for the dosing of the first patient in a long-term extension trial [74]. - Under the GSK Agreement, the company received $700 million in upfront payments, with potential additional milestone payments of up to $1.5 billion [74]. - Collaboration revenue for Q2 2023 was $56.2 million, down 29.5% from $79.9 million in Q2 2022, primarily due to the termination of the AL003 program and a decrease in revenue from latozinemab programs [83]. Expenses and Cost Management - Research and development expenses decreased to $46.2 million in Q2 2023 from $54.5 million in Q2 2022, a reduction of 15.4% attributed to prioritizing late-stage programs [84]. - General and administrative expenses fell to $13.6 million in Q2 2023 from $15.8 million in Q2 2022, a decrease of 13.9% driven by lower consulting expenses [86]. - The company expects research and development expenses to increase substantially as it advances product candidates through clinical trials and seeks regulatory approvals [77]. - A workforce reduction of approximately 11% was initiated to align resources with strategic priorities, impacting about 30 employees [71]. Cash and Investments - As of June 30, 2023, the company had $630.0 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $624.2 million [96]. - Cash used in operating activities for the six months ended June 30, 2023, was $91.6 million, primarily due to a net loss of $44.5 million [104]. - Cash used in investing activities for the six months ended June 30, 2023, was $66.9 million, a decrease from $237.9 million in the same period of 2022 [105]. - Cash provided by financing activities for the six months ended June 30, 2023, was $1.9 million, down from $3.4 million in the same period of 2022 [106]. - Approximately $5.4 million of cash exceeded the FDIC insurance limit as of June 30, 2023 [110]. Future Outlook - The company expects to fund operations and capital expenditures through 2025 with existing cash and marketable securities, while anticipating increased expenses related to ongoing activities [99]. - The company plans to complete enrollment in the INFRONT-3 clinical trial for latozinemab in the fourth quarter of 2023, focusing on symptomatic participants [69]. Accounting and Risk Management - There have been no material changes to the company's critical accounting policies and estimates since the last annual report filed on February 28, 2023 [107]. - The company has not had a formal hedging program for foreign currency, and foreign currency transaction gains and losses have not been material [111]. - The company’s investment activities aim to preserve capital while maximizing income from investments without assuming significant risk [110]. - An immediate 100 basis point increase or decrease in interest rates would cause a change in fair value of approximately $2.3 million as of June 30, 2023 [110].