ALEC — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are a biotechnology company developing therapies for neurodegenerative diseases, with a focus on areas of high unmet medical need. Our work is informed by advances in disease biology, including the roles of misfolded or deficient proteins, lysosomal dysfunction, and immune and neuronal pathway di…

• Our objective is to develop product candidates that address disease through targeted mechanisms, such as removing pathogenic proteins, replacing deficient proteins, and restoring normal cellular function. We are advancing a portfolio of programs focused on genetically validated targets, supported by…

• A key component of our strategy is the development and application of our Alector Brain Carrier (ABC) platform, a proprietary blood-brain barrier (BBB) delivery technology designed to improve central nervous system exposure across multiple therapeutic modalities. Built on the core design principles …

• Our AL037/AL137 program, which pairs our proprietary anti-amyloid beta (Aβ) antibody with our proprietary ABC platform, is in preclinical development for Alzheimer's disease (AD). It is designed to remove brain Aβ plaques, with the goal of minimizing treatment-related incidence and/or severity of am…

• Following successful completion of IND-enabling studies, we intend to select AL037 or AL137 for submission of an Investigational New Drug (IND) application, targeted for the first quarter of 2027.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are a clinical stage biotechnology company with a mission to make degenerative brain disorders history. Our robust portfolio of therapies is focused on counteracting the devastating progression of neurodegenerative diseases, particularly in areas of high unmet need where therapeutic options are l…

• We aim to develop product candidates that remove toxic proteins, replace critical deficient proteins, and restore immune and nerve cells to normal function. To pursue this aim, we are advancing a portfolio of programs that address genetically validated targets. These programs leverage our deep under…

• With a singular focus on transforming brain health, our research and drug discovery engine enables us to identify targets and develop a broad portfolio of product candidates validated by human genetics. These candidates, including those utilizing ABC technology, are designed to cross the BBB in suff…

• Nivisnebart (formerly AL101/GSK4527226) is currently in clinical development. We are pursuing our brain-penetrant anti-amyloid beta antibody in Alzheimer’s disease (AD) and our GCase enzyme replacement therapy in Parkinson’s disease (PD).

• In July 2021, we entered into a Collaboration and License Agreement with Glaxo Wellcome UK Limited, a subsidiary of GlaxoSmithKline plc (GSK Agreement), to collaborate on the global development and commercialization of progranulin (PGRN)-elevating monoclonal antibodies, including latozinemab and niv…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are a smaller reporting company, as defined by Rule 12b-2 of the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. The primary objective of our investment activities is to preserve capital to fund our operations. We also seek to maximize income from our investments without assuming si…

• We had cash, cash equivalents, and marketable securities of $291.1 million as of September 30, 2025, which consisted primarily of money market funds, U.S. treasury securities, corporate bonds, certificates of deposit, and commercial paper. Such interest-earning instruments carry a degree of interest…

• We deposit cash and cash equivalents with high credit quality financial institutions to minimize risk with respect to any amounts in excess of insurance limitations. Cash and cash equivalents held at these deposit accounts are currently insured by the Federal Deposit Insurance Corporation (FDIC) up …

• Our expenses are generally denominated in U.S. dollars. However, we have entered into a limited number of contracts with vendors for research and development services with payments denominated in foreign currencies, including the Euro. We are subject to foreign currency transaction gains or losses o…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We have concentrated our research and development efforts on the treatment of neurodegenerative diseases, a field that has seen both limited success in drug development and evolving standards for regulatory approval. Further, our product candidates are based on innovative approaches and technologies…

• We may not be successful in developing product candidates that effectively compete with therapeutics that are developed or commercialized by our competitors, including therapeutics that affect the same biological targets or pathways.

• Changes or reductions in the FDA’s or other government agencies’ management and personnel, or changes in such agencies’ funding, could impact their ability to hire and retain key leadership and other personnel, impact the timing for development or commercialization of new products and services, or o…

• We expect to depend on collaborations with third parties for the research, development, and commercialization of certain product candidates we may develop. If any such collaborations are not successful, we may not be able to realize the market potential of those product candidates.

• We expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We and our collaboration partners rely on service providers, including contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), for our research and product development activities and product candidates. If we cannot obtain products or use services fro…

• We may not be successful in our efforts to carry out our obligations under our collaborations for our product development and research programs; for instance, without limitation, we may not complete in a timely manner or at all our contractual obligations to GSK.

• We have concentrated a substantial portion of our research and development efforts on the treatment of neurodegenerative diseases, a field that has seen both limited success in drug development and evolving standards for regulatory approval.

• We may not accurately predict the time and cost of development and subsequent regulatory approval for our product candidates, which are based on innovative approaches and technologies to address the complex mechanisms underlying neurodegeneration.

• We may not be successful in developing product candidates that effectively compete with therapeutics that are developed or commercialized by our competitors, including therapeutics that affect the same biological targets or pathways.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• (c) During our last fiscal quarter, no officer or director (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a "non-Rule 10b5-1 trading arrangement" (each as defined in Item 408 of Regulation S-K).

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• (c) During our last fiscal quarter, the following officers and directors adopted or terminated a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408, as follows:

• On September 5, 2025, Grace Wong-Sarad, the Company’s Vice President of Accounting and Principal Accounting Officer, adopted a Rule 10b5-1 trading plan. Ms. Wong-Sarad's plan provides for (i) the exercise of vested stock options to purchase an aggregate of up to 84,315 shares of the Company’s common…

• Other than as disclosed above, during our last fiscal quarter, no other officer or director (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a "non-Rule 10b5-1 trading arrangement" (each as defined in Item 408 of Regulation S-K).