Alector Reports Third Quarter 2021 Financial Results
Initiated Phase 2 Clinical Trial of AL001 for the Treatment of Amyotrophic Lateral Sclerosis
Executed a Global Collaboration with GSK to Co-development and Co-commercialize Alector’s Progranulin Franchise Molecules for the Treatment of a Range of Neurodegenerative Diseases
“During the third quarter, Alector reached a significant inflection point, validating our immuno-neurology approach and advancing our lead programs as we strive to help patients with neurodegenerative diseases,” said
Clinical Updates
Progranulin Franchise
- In September, Alector initiated a Phase 2 clinical trial of AL001 in amyotrophic lateral sclerosis (ALS) patients with a C9orf72 genetic mutation. The six-month, randomized, double-blind, placebo-controlled, multicenter study is expected to enroll approximately 45 adult participants with C9orf72-associated ALS. The primary endpoint of the study is safety, tolerability, pharmacokinetics and pharmacodynamics of AL001, including plasma and cerebrospinal fluid (CSF) progranulin levels. The Phase 2 will also gather data on changes to multiple liquid biomarkers. ALS is the first of several indications beyond frontotemporal dementia where elevating progranulin levels is thought to have potential neuroprotective benefits.
- AL001 received orphan drug designation from the
European Commission for the treatment of frontotemporal dementia. Orphan drug designation in the EU may be granted for medicines in development for debilitating or life-threatening conditions that affect fewer than five in 10,000 people in the EU and provides benefits to the sponsor such as protocol assistance, reduced regulatory fees and extended market exclusivity. AL001 has previously received Fast Track and Orphan Drug designations from theU.S. Food and Drug Administration . - Twelve-month data from the open-label INFRONT-2 Phase 2 clinical trial of AL001 in patients with frontotemporal dementia with a progranulin mutation (FTD-GRN) were presented at the Alzheimer’s
Association International Conference (AAIC) held inJuly 2021 . AL001 showed a favorable safety profile, successful elevation of progranulin levels and encouraging evidence that treatment may slow disease progression.(1) - In July, Alector and GlaxoSmithKline (GSK) entered into a global collaboration to co-develop and co-commercialize AL001 and AL101 for the treatment of neurodegenerative diseases, including FTD-GRN, as well as other forms of FTD, ALS, Alzheimer’s disease and Parkinson’s disease. Under the terms of the agreement, Alector will receive
$700 million in upfront payments,$500 million of which was received inAugust 2021 with a second payment to occur in the first quarter of 2022.
Alzheimer’s Disease Portfolio
- Two posters were presented at the 2021 AAIC for Alector’s AL002 program providing data from a Phase 1 study in healthy volunteers and details on the design of the ongoing INVOKE-2 Phase 2 clinical trial. AL002 is Alector’s first-in-class monoclonal antibody that binds to the TREM2 receptor to optimize microglial activity in the brain. Alector is developing AL002 as a potential treatment for Alzheimer’s disease in collaboration with AbbVie.
Sam Jackson , M.D., MBA, andLinda Rubinstein joined Alector’s executive leadership team assuming the roles of interim Chief Medical Officer and interim Chief Financial Officer, respectively.Dr. Jackson joined Alector in 2020 as Senior Vice President, Clinical Sciences overseeing Alector’s clinical science and clinical operations functions.Ms. Rubinstein brings significant industry and financial experience to Alector, having served as Chief Financial Officer or interim Chief Financial Officer to numerous biotechnology companies.
Elizabeth Garofalo , M.D., a veteran biopharmaceutical executive with more than 25 years of experience in global clinical development and regulatory affairs with a focus on neurology, was appointed to Alector’s Board of Directors.
Third Quarter 2021 Financial Results
Revenue. Collaboration revenue for the quarter ended September 30, 2021, was $182.4 million, compared to $5.9 million for the same period in 2020. In August, Alector received
R&D Expenses. Total research and development expenses for the quarter ended September 30, 2021, were $43.1 million, compared to
G&A Expenses. Total general and administrative expenses for the quarter ended
Net Income (Loss). For the quarter ended September 30, 2021, Alector reported a net income of $126.6 million, or
Cash Position. Cash, cash equivalents, and marketable securities were $777.9 million as of September 30, 2021.
About Alector
Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases.
(1) Paul, Robert, et al, “AAIC 2021 “Twelve month Results from the INFRONT-2 Phase 2 Open-label Clinical Study of AL001 in Frontotemporal Dementia Patients with a Progranulin Mutation (FTD-GRN)”
(2) Guerreiro, et al. “TREM2 Variants in Alzheimer’s Disease” NEJM. 2013; and Jonsson, et al. “Variant of TREM2 associated with the risk of Alzheimer's disease” NEJM 2013
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 our Quarterly Report on Form 10-Q, as filed on
Selected Consolidated Balance Sheet Data
(in thousands)
2021 | 2020 | |||||
Cash, cash equivalents, and marketable securities | $ | 777,850 | $ | 413,308 | ||
Total assets | 854,226 | 488,251 | ||||
Total current liabilities (excluding deferred revenue) | 38,132 | 44,202 | ||||
Deferred revenue (including current portion) | 439,212 | 132,303 | ||||
Total liabilities | 518,336 | 220,721 | ||||
Total stockholders’ equity | 335,890 | 267,530 |
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
Three Months Ended |
Nine Months Ended |
||||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 |
||||||||||||||||||||||||
Collaboration revenue | $ | 182,413 | $ | 5,904 | $ | 193,091 | $ | 16,245 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||
Research and development | 43,066 | 43,819 | 136,617 | 112,486 | |||||||||||||||||||||||
General and administrative | 13,018 | 15,834 | 38,105 | 46,175 | |||||||||||||||||||||||
Total operating expenses | 56,084 | 59,653 | 174,722 | 158,661 | |||||||||||||||||||||||
Income (loss) from operations | 126,329 | (53,749 | ) | 18,369 | (142,416 | ) | |||||||||||||||||||||
Other income, net | 268 | 1,045 | 910 | 4,367 | |||||||||||||||||||||||
Net income (loss) | $ | 126,597 | $ | (52,704 | ) | $ | 19,279 | $ | (138,049 | ) | |||||||||||||||||
Net income (loss) per share: Net income (loss) per share, basic |
$ | 1.56 | $ | (0.67 | ) | $ | 0.24 | $ | (1.78 | ) | |||||||||||||||||
Net income (loss) per share, diluted | $ | 1.49 | $ | (0.67 | ) | $ | 0.23 | $ | (1.78 | ) | |||||||||||||||||
Weighted-average shares used in calculating: Basic net income (loss) per share |
80,964,701 | 78,771,930 | 80,048,758 | 77,340,896 | |||||||||||||||||||||||
Diluted net income (loss) per share | 85,232,690 | 78,771,930 | 82,871,254 | 77,340,896 |
Alector Contacts
VP, Communications and Investor Relations
650-808-7016
michelle.corral@alector.com
1AB (media)
973-271-6085
dan@1abmedia.com
212.600.1902
alector@argotpartners.com
Source: Alector, Inc.