Alector Reports Second Quarter 2020 Financial Results and Provides Corporate Update
- Pivotal Phase 3 trial of AL001 initiated for treatment of frontotemporal dementia due to a progranulin gene mutation (FTD-GRN)
- Promising preliminary data from AL001 Phase 1b and Phase 2 open-label studies presented at Alzheimer’s
Association International Conference - AL002, AL003 and AL014 programs for the treatment of Alzheimer’s disease and AL101 neurology program continue to progress
- Strong cash and investments of
$503.6 million to support execution of clinical, research and operational goals
“I am proud of the continued progress across our portfolio, most notably the initiation of our pivotal Phase 3 trial evaluating AL001 for the treatment of people with frontotemporal dementia,” said
Clinical Pipeline Highlights and Corporate Update
Progranulin Portfolio:
- Announced dosing of first participant in pivotal Phase 3 trial evaluating AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In
July 2020 , Alector announced that the first participant was dosed in INFRONT-3, a global, pivotal Phase 3 trial, evaluating the efficacy and safety of AL001 in pre-symptomatic and symptomatic participants with FTD-GRN. The trial will enroll up to 180 participants at approximately 50 centers globally.
- Presented preliminary findings from AL001 Phase 1b and Phase 2 open label studies at the Alzheimer’s
Association International Conference (AAIC). InJuly 2020 , Alector presented promising preliminary data from the Phase 1b and Phase 2 open-label studies evaluating the long-term dosing of AL001 in patients with FTD-GRN at the virtual AAIC. The data demonstrated that AL001 was well-tolerated in both studies. Additionally, in the Phase 2 study, treatment with AL001 led to sustained restoration of plasma progranulin (PGRN) levels in all FTD-GRN participants back to the normal range. These preliminary findings also showed that the majority of symptomatic FTD-GRN participants (six out of the eight) experienced a decrease in neurofilament light chain levels (NfL), an exploratory biomarker of neurodegeneration, from baseline at the last measured time point. Alector plans to continue this 96-week open-label Phase 2 study and present additional data from study participants, including findings on safety, fluid and imaging biomarkers, and clinical outcomes assessments, at a later date.
Alzheimer’s Disease Portfolio:
- Continued progress for multiple Alzheimer’s disease clinical programs:
- In collaboration with its partner AbbVie, Alector plans to initiate a Phase 2 study evaluating AL002 in patients with Alzheimer’s disease in the second half of 2020.
- Alector continues to advance the Phase 1b trial of AL003 in Alzheimer’s disease, also being developed in collaboration with AbbVie.
- Alector plans to initiate Phase 1 development for AL014 in the first half of 2021. AL014 is the latest prioritized candidate that targets MS4A4A, 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 collaboration with its partner AbbVie, Alector plans to initiate a Phase 2 study evaluating AL002 in patients with Alzheimer’s disease in the second half of 2020.
- Published new findings from the AL002 program in leading research journal. In
June 2020 , Alector announced the publication of preclinical and Phase 1 data demonstrating the potential of AL002 as a treatment for Alzheimer’s disease inThe Journal of Experimental Medicine .
- Published research showing role of Trem2 in a multiple sclerosis disease model. In
August 2020 , Alector researchers and academic collaborators published findings highlighting the role of Trem2 as induced by AL002a (a murine specific Trem2 antibody) in promoting myelin debris clearance and remyelination in a cuprizone mouse model of multiple sclerosis in Acta Neuropathologica.
Ongoing COVID-19 Response Activities:
- Alector continues to actively monitor the evolving impact of COVID-19 on its business and clinical operations, with a primary focus on the health and safety of clinical trial participants, clinical trial site teams and employees.
- To help mitigate the potential effects of the ongoing COVID-19 pandemic on current participant recruitment activities, the Company has implemented a number of activities to enhance clinical trial continuation and patient recruitment including: increased remote support for clinical sites and study staff; evaluation of the availability of in-home dosing and monitoring services for trial participants; and concierge travel support for trial participants who prefer to visit clinical sites in person. A targeted disease education campaign is also planned to help drive awareness of FTD and the AL001 Phase 3 clinical trial.
Second 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 $503.6 million as of June 30, 2020. The Company believes that its cash and investments as of
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 is developing a broad portfolio of 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. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. Alector is headquartered in South San Francisco,
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 11, 2020, as well as the other documents Alector files from time to time with the
Selected Consolidated Balance Sheet Data
(in thousands)
2020 | 2019 | |||||
Cash, cash equivalents, and marketable securities | $ | 503,640 | $ | 353,073 | ||
Total assets | 572,030 | 421,913 | ||||
Total current liabilities (excluding deferred revenue) | 33,117 | 31,805 | ||||
Deferred revenue (including current portion) | 143,060 | 153,401 | ||||
Total liabilities | 216,699 | 227,170 | ||||
Total stockholders’ equity | 355,331 | 194,743 |
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
Three Months Ended |
Six Months Ended |
||||||||||||||||||||||||||
2020 |
2019 |
2020 | 2019 |
||||||||||||||||||||||||
Collaboration revenue | $ | 3,170 | $ | 6,917 | $ | 10,341 | $ | 12,522 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||
Research and development | 34,062 | 25,640 | 68,667 | 46,247 | |||||||||||||||||||||||
General and administrative | 15,697 | 8,429 | 30,341 | 14,188 | |||||||||||||||||||||||
Total operating expenses | 49,759 | 34,069 | 99,008 | 60,435 | |||||||||||||||||||||||
Loss from operations | (46,589 | ) | (27,152 | ) | (88,667 | ) | (47,913 | ) | |||||||||||||||||||
Other income, net | 1,263 | 2,592 | 3,322 | 4,793 | |||||||||||||||||||||||
Net loss | $ | (45,326 | ) | $ | (24,560 | ) | $ | (85,435 | ) | $ | (43,120 | ) | |||||||||||||||
Net loss per share, basic and diluted | $ | (0.58 | ) | $ | (0.36 | ) | $ | (1.11 | ) | $ | (0.77 | ) | |||||||||||||||
Shares used in computing net loss per share, basic and diluted | 78,415,195 | 67,327,975 | 76,617,938 | 55,643,352 |
Source:
Contacts
Media
Vice President, Communications and Public Affairs
301-928-4650
erica.jefferson@alector.com
1AB
973-271-6085
dan@1abmedia.com
or
Investors:
ir@alector.com
Source: Alector, Inc.