Alector Reports Third Quarter 2020 Financial Results and Provides Corporate Update
- Global Phase 3 INFRONT-3 trial evaluating AL001 for treatment of frontotemporal dementia due to a progranulin gene mutation (FTD-GRN) currently enrolling participants
- On track to initiate Phase 2 study for AL002 in Alzheimer’s disease in 2020
- $461.7 million in cash and investments to support execution of clinical, research and operational goals
“We continued to make progress across our portfolio during the third quarter, notably advancing AL001 into our first Phase 3 pivotal trial in people living with frontotemporal dementia,” said
Recent Clinical Pipeline Highlights and Corporate Update
- Initiated Phase 3 AL001 trial in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In
July 2020, Alector initiated its pivotal, global Phase 3 trial, INFRONT-3, evaluating AL001 for the treatment of FTD-GRN and is continuing to enroll participants. The trial is evaluating the efficacy and safety of AL001 in pre-symptomatic and symptomatic participants with FTD-GRN. Participants in the trial will be randomized to receive AL001 or placebo intravenously and will be given the option to continue receiving treatment in an open-label extension study. FTD-GRN affects approximately 15,000 people in the United Statesand Europeand up to approximately 60,000 people in the U.S.that are pre-symptomatic carriers of the GRN mutation.
- AL001 Phase 2 open label study continues to progress. Alector plans to present additional data from the Phase 2 trial of AL001 in pre-symptomatic and symptomatic FTD-GRN participants and an additional cohort of FTD-C9orf72 patients in 2021. The data will include findings on safety, fluid and imaging biomarkers and clinical outcomes assessments, providing additional insights to the mechanism of action and safety of AL001 in this population with great unmet medical need.
- AL101 Phase 1a study continues to advance. The company anticipates reporting preliminary findings from the Phase 1a study of AL101 in healthy volunteers in 2021. The Company continues to develop a subcutaneous formulation for the investigational product that will be pursued in additional neurological diseases.
Alzheimer’s Disease Portfolio:
- In collaboration with its partner AbbVie, the Company expects to initiate a Phase 2 trial evaluating AL002 in patients with Alzheimer’s disease in 2020. Alector continues to work on clinical site activation and patient screening activities in anticipation of dosing the first study participant.
- A Phase 1b trial of AL003 in Alzheimer’s disease, also being developed in collaboration with AbbVie, continues to progress, with data expected in 2021.
- Alector plans to initiate Phase 1 development for its latest prioritized product candidate in its development program that targets MS4A4A, a major risk gene for Alzheimer’s disease that encodes a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability, in the next 12-18 months.
- Alector scientists provided an overview of two different investigational product candidates at two recent scientific conferences. The first is AL008, a novel, investigational, antibody product candidate that combines inhibition of the CD47-SIRP-alpha (SIRPα) pathway, a potent immune checkpoint pathway co-opted by tumors to evade the immune system, with stimulation of activating Fc receptors to yield a potential best-in-class product. The second is the Company’s latest prioritized investigational product candidate within its ADP009 development program, which is a first-in-class multi Siglec inhibitor that works to enhance the innate and adaptive immune system response by blocking a critical glycan checkpoint pathway that drives immune inhibition. This product candidate is being developed in oncology and the Company believes it could also have potential therapeutic application to neurodegenerative disorders.
Ongoing COVID-19 Response Activities:
- Alector continues to actively monitor the evolving COVID-19 pandemic and its ongoing impact on business and clinical operations, with a primary focus on the health and safety of clinical trial participants, clinical trial site teams and employees.
- Although most clinical trial activities have resumed, the Company has experienced delays in enrollment and ongoing site visits as a result of the COVID-19 pandemic during previous quarters. The Company remains optimistic that future enrollment and follow up will continue for its clinical programs at an expected pace, and Alector is prepared for any future disruptions that might adversely impact currently scheduled timelines and patient follow-up and care.
Resolution of Arbitration in Alector’s Favor:
November 2, 2020, Alector provided an update on its confidential arbitration proceedings against Dr. Asa Abeliovich, co-founder and CEO of Prevail Therapeutics. An independent arbitrator issued a confidential decision in favor of Alector, finding Dr. Abeliovich liable for breach of his confidentiality agreement and for spoliation based on his destruction of documents relevant to the proceeding. The arbitrator awarded damages for breach of the agreement and sanctions for the spoliation, as well as violation of orders during the proceeding. Monetary damages will be determined in further proceedings.
Third Quarter 2020 Financial Results
Revenue. Collaboration revenue for the quarter ended
R&D Expenses. Total research and development expenses for the quarter ended
G&A Expenses. Total general and administrative expenses for the quarter ended
Net Loss. For the quarter ended
Cash Position. Cash, cash equivalents, and marketable securities were $461.7 million as of September 30, 2020. The Company believes that its cash and investments as of
Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company’s immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. This scientific approach is also the basis for the Company’s immuno-oncology programs. Alector is headquartered in South San Francisco,
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to market conditions, Alector and its business as set forth in Alector’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 10, 2020, as well as the other documents Alector files from time to time with the
Selected Consolidated Balance Sheet Data
|Cash, cash equivalents, and marketable securities||$||461,714||$||353,073|
|Total current liabilities (excluding deferred revenue)||44,491||31,805|
|Deferred revenue (including current portion)||137,156||153,401|
|Total stockholders’ equity||310,191||194,743|
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||43,819||28,519||112,486||74,766|
|General and administrative||15,834||8,326||46,175||22,514|
|Total operating expenses||59,653||36,845||158,661||97,280|
|Loss from operations||(53,749||)||(34,149||)||(142,416||)||(82,062||)|
|Other income, net||1,045||2,411||4,367||7,204|
|Net loss per share, basic and diluted||$||(0.67||)||$||(0.47||)||$||(1.78||)||$||(1.25||)|
|Shares used in computing net loss per share, basic and diluted||78,771,930||67,572,452||77,340,896||59,663,773|
Vice President, Communications and Public Affairs
Source: Alector, Inc.