UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 28, 2023, Alector, Inc. (the “Company”) announced its financial results for the quarter ended December 31, 2022. A press release announcing these results, which is attached hereto as Exhibit 99.1, is incorporated herein by reference.
All of the information furnished in Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ALECTOR, INC. |
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Date: |
February 28, 2023 |
By: |
/s/ Arnon Rosenthal |
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Arnon Rosenthal, Ph.D. |
NEWS RELEASE
Exhibit 99.1
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
and Provides Corporate Update
On track to complete enrollment in the INVOKE-2 Phase 2 clinical trial of AL002 in patients with early Alzheimer’s disease in Q3 2023, with data readout expected by Q4 2024
Preparing to engage with regulatory authorities in mid-2023 and targeting data readout from the pivotal INFRONT-3 clinical trial for latozinemab in early 2025 pending regulatory feedback
Additional data from the INFRONT-2 Phase 2 clinical trial of latozinemab in FTD-C9orf72 expected during the second half of 2023
Company and GSK plan to advance AL101 program in 2023, with the initiation of a PK bridging study to be followed by a global Phase 2 clinical trial in early Alzheimer’s disease
$712.9 million in cash, cash equivalents and investments provide runway through 2025
South San Francisco, Calif., February 28, 2023 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported fourth quarter and full year 2022 financial results and recent portfolio and business updates. As of December 31, 2022, Alector’s cash, cash equivalents and investments totaled $712.9 million.
“2022 was marked by significant momentum and focus on our programs and prioritization across our pipeline as we continued to cement our position as an innovator in advancing immuno-neurology,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We shared positive data from our INFRONT-2 Phase 2 trial of latozinemab in patients with symptomatic FTD-C9orf72 and advanced our INVOKE-2 Phase 2 Alzheimer’s disease study with AL002, the most advanced TREM2 candidate in clinical development. We are encouraged by recent progress in the Alzheimer’s disease space and believe our first-in-class drug candidates that harness the power of microglia, the brain’s immune cells, have the potential to improve neurodegeneration outcomes either as stand-alone therapies or potentially in combination with anti-beta amyloid drugs.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector added, “Last year was transformational for Alector as we continued to strengthen our world-class and seasoned leadership team and bolster key talent across the organization. Looking ahead, we believe we are well-positioned both financially and organizationally to execute on our strategic priorities in 2023 and beyond.”
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
Page 2
Pipeline Prioritization and Cash Runway Extension Through 2025
Alector plans to prioritize its late-stage immuno-neurology programs, including its progranulin and TREM2 product candidates, to extend cash runway through 2025.
Recent Clinical Updates and 2023 Milestones
Immuno-Neurology Portfolio
Progranulin Programs (Latozinemab, AL101) Being Developed in Collaboration with GSK
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
Page 3
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie
MS4A Program (AL044)
Recent Corporate Updates
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
Page 4
Fourth Quarter and Full Year 2022 Financial Results
Revenue. Collaboration revenue for the quarter ended December 31, 2022, was $14.4 million, compared to $14.0 million for the same period in 2021. Collaboration revenue for the year ended December 31, 2022, was $133.6 million, compared to $207.1 million for the same period in 2021. The decrease in year-over-year collaborative revenue was primarily due to $173.4 million collaboration revenue recognized from AL001 FTD-GRN license provided as part of the GSK Agreement in 2021, offset by revenue recognized in 2022 for GSK and AbbVie programs, including revenue recognized from the termination of the AL003 program.
R&D Expenses. Total research and development expenses for the quarter ended December 31, 2022, were $54.5 million, compared to $52.8 million for the same period in 2021. Total research and development expenses for the year ended December 31, 2022, were $210.4 million compared to $189.4 million for the same period in 2021. The increase in R&D expenses was mainly driven by increased spending to support advancement of several clinical and preclinical programs, including latozinemab and AL002, as well as increased personnel-related expenses.
G&A Expenses. Total general and administrative expenses for the quarter ended December 31, 2022, were $15.4 million, compared to $16.9 million for the same period in 2021. Total general and administrative expenses for the year ended December 31, 2022, were $61.0 million compared to $55.0 million for the same period in 2021. The increase in year-over-year G&A expenses is primarily due to personnel-related expenses and information technology expenses to support the company's growth.
Net Loss. For the quarter ended December 31, 2022, Alector reported net loss of $52.4 million, or $0.63 net loss per share, compared to a net loss of $55.6 million, or $0.68 per share, for the same period in 2021. For the year ended December 31, 2022, Alector reported net loss of $133.3 million or $1.62 net loss per share, compared to a net loss of $36.3 million, or $0.45 net loss per share, for the same period in 2021.
Cash Position. Cash, cash equivalents, and investments were $712.9 million as of December 31, 2022. Management anticipates that this will be sufficient to fund Alector's operations through 2025.
2023 Guidance. Management anticipates, for the year ending 2023, collaboration revenue to be between $15 million and $25 million, total research and development expenses to be between $225 million and $245 million and total general and administrative expenses to be between $60 million and $70 million.
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 Reports Fourth Quarter and Full Year 2022 Financial Results
Page 5
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 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. 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 and ongoing preclinical studies and 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 for 2022, filed 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)
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December 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents, and marketable securities |
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$ |
712,851 |
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$ |
735,251 |
Total assets |
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787,648 |
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814,658 |
Total current liabilities (excluding deferred revenue) |
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45,578 |
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48,752 |
Deferred revenue (including current portion) |
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491,601 |
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425,218 |
Total liabilities |
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573,206 |
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513,934 |
Total stockholders’ equity |
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214,442 |
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300,724 |
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
Page 6
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
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Three Months Ended |
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Twelve Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Collaboration revenue |
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$ |
14,440 |
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$ |
13,994 |
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$ |
133,617 |
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$ |
207,085 |
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Operating expenses: |
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Research and development |
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54,493 |
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52,790 |
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210,418 |
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189,407 |
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General and administrative |
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15,385 |
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16,933 |
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61,033 |
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55,038 |
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Total operating expenses |
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69,878 |
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69,723 |
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271,451 |
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244,445 |
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Loss from operations |
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(55,438) |
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(55,729) |
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(137,834) |
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(37,360) |
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Other income, net |
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3,731 |
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121 |
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7,778 |
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1,031 |
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Net loss before income tax |
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(51,707) |
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(55,608) |
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(130,056) |
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(36,329) |
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Income tax expense |
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721 |
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— |
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3,254 |
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— |
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Net loss |
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$ |
(52,428) |
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$ |
(55,608) |
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$ |
(133,310) |
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$ |
(36,329) |
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Net loss per share, basic and diluted |
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$ |
(0.63) |
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$ |
(0.68) |
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$ |
(1.62) |
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$ |
(0.45) |
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Shares used in computing net loss per share basic and diluted |
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82,763,688 |
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81,510,894 |
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82,467,587 |
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80,416,936 |
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Alector Contacts:
Alector
Katie Hogan
202-549-0557
katie.hogan@alector.com
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Alector Reports Fourth Quarter and Full Year 2022 Financial Results
Page 7
Argot Partners (investors)
Laura Perry/Carrie McKim
212.600.1902
alector@argotpartners.com