05/05/2022 | Press release | Distributed by Public on 05/05/2022 14:10
Data from INFRONT-2 Phase 2 clinical trial showed that FTD-C9orf72 patients treated with AL001 (latozinemab) demonstrated a trend towards an annual delay in disease progression of approximately 54 percent relative to the ALLFTD matched control cohort
INFRONT-2 FTD-C9orf72 cohort represents first clinical dataset from an indication in which treatment with latozinemab resulted in a two- to three-fold increase in progranulin above physiological levels
Strengthening executive leadership team by adding Gary Romano, M.D., Ph.D., as incoming Chief Medical Officer, and Marc Grasso, M.D., as Chief Financial Officer
$868.6 million in cash, cash equivalents, and marketable securities provide runway into mid-2024
SOUTH SAN FRANCISCO, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported first quarter 2022 financial results and recent portfolio and business updates. As of March 31, 2022, Alector's cash, cash equivalents, and marketable securities totaled $868.6 million.
"We made significant progress in the first quarter, highlighted by the presentation of 12-month data from our INFRONT-2 Phase 2 clinical trial of latozinemab in patients with symptomatic FTD-C9orf72, in which treatment with latozinemab demonstrated target engagement and resulted in increases in progranulin levels above physiological levels in all patients," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "Data from the FTD-C9orf72 cohort builds upon the results observed in our studies to date in patients with symptomatic FTD-GRN. The totality of the data supports our approach of elevating progranulin levels to address a range of neurodegenerative diseases including FTD, ALS, Parkinson's disease and Alzheimer's disease. We look forward to evaluating latozinemab and AL101 in multiple indications as part of our progranulin franchise in partnership with GlaxoSmithKline."
Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "In parallel to advancing and expanding our progranulin franchise, we continue to make progress in our Alzheimer's and oncology programs. Our INVOKE-2 Phase 2 clinical trial evaluating AL002 in slowing disease progression in individuals with early Alzheimer's disease is ongoing, and we also expect to initiate a Phase 1 trial for AL044, which targets MS4A, a major risk locus for Alzheimer's disease, in the second half of 2022. Additionally, we presented exciting preclinical data from our AL009 immuno-oncology program at the 2022 AACR Annual Meeting, with a Phase 1 trial slated to begin within the next year. This clinical momentum, coupled with the addition of veteran neurodegeneration expert, Gary Romano, as Chief Medical Officer, puts Alector in a strong position to execute our goal of halting the destruction caused by neurodegenerative diseases."
Recent Clinical Updates
Progranulin Franchise Portfolio
Alzheimer's Disease Portfolio
Immuno-oncology Portfolio
Recent Corporate News
First Quarter 2022 Financial Results
Revenue. Collaboration revenue for the quarter ended March 31, 2022, was $24.5 million, compared to $4.1 million for the same period in 2021. This increase was primarily due to revenue recognized from the GSK Agreement.
R&D Expenses. Total research and development expenses for the quarter ended March 31, 2022, were $53.0 million, compared to $45.7 million for the quarter ended March 31, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses, as well as increased spending to support advancement of several clinical and preclinical programs.
G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2022, were $15.6 million, compared to $11.0 million for the same period in 2021 was primarily due to an increase in personnel-related expenses and increase in legal expenses from the arbitration award in 2021 that reduced expenses.
Net Loss. For the quarter ended March 31, 2022, Alector reported a net loss of $44.6 million, or $0.54 per share, compared to a net loss of $52.2 million, or $0.66 per share, for the same period in 2021.
Cash Position. Cash, cash equivalents, and marketable securities were $868.6 million as of March 31, 2022. Management expects that this will be sufficient to fund current operations into mid-2024.
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 has discovered and 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. Alector'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, California. For additional information, please visit www.alector.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, product candidates, planned preclinical studies, clinical trials, expected milestones, expectations of our collaborations, and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector's Annual Report on Form 10-K, as filed on February 24, 2022, with the Securities and Exchange Commission ("SEC"), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector's forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.
Selected Consolidated Balance Sheet Data
(in thousands)
March 31, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Cash, cash equivalents, and marketable securities | $ | 868,571 | $ | 735,251 | ||||
Total assets | 954,457 | 814,658 | ||||||
Total current liabilities (excluding deferred revenue) | 47,267 | 48,752 | ||||||
Deferred revenue (including current portion) | 600,744 | 425,218 | ||||||
Total liabilities | 686,920 | 513,934 | ||||||
Total stockholders' equity | 267,537 | 300,724 | ||||||
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
Three Months Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Collaboration revenue | $ | 24,474 | $ | 4,110 | ||||
Operating expenses: | ||||||||
Research and development | 53,043 | 45,733 | ||||||
General and administrative | 15,554 | 11,012 | ||||||
Total operating expenses | 68,597 | 56,745 | ||||||
Loss from operations | (44,123 | ) | (52,635 | ) | ||||
Other income, net | 264 | 464 | ||||||
Loss before income tax | (43,859 | ) | (52,171 | ) | ||||
Income tax expense | 758 | - | ||||||
Net loss | $ | (44,617 | ) | $ | (52,171 | ) | ||
Net loss per share, basic and diluted | $ | (0.54 | ) | $ | (0.66 | ) | ||
Shares used in computing net loss per share basic and diluted |
82,102,191 | 79,386,836 |
Contacts:
1AB (media)
Dan Budwick
973-271-6085
[email protected]
Argot Partners (investors)
Eric Kasper/Carrie McKim
Argot Partners
212.600.1902
[email protected]
Source: Alector, Inc.