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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 August 4, 2022 Alector, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 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 |
|
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.
|
|
|
ALECTOR, INC. |
|
|
|
|
Date: |
August 4, 2022 |
By: |
/s/ Arnon Rosenthal |
|
|
|
Arnon Rosenthal, Ph.D. |
NEWS RELEASE
Exhibit 99.1
Alector Reports Second Quarter 2022 Financial Results and Provides Business Update
Investigational New Drug Application submitted for AL044, a novel drug candidate targeting an Alzheimer’s disease risk gene
Expanding clinical sites to drive additional enrollment in the INFRONT-3 pivotal study for latozinemab (AL001) and enrollment continues in the INVOKE-2 Phase 2 study for AL002
Peter Heutink, Ph.D., to join company as Chief Scientific Officer
John Maraganore appointed as strategic advisor
$808.9 million in cash, cash equivalents and investments provide runway into H2-2024
South San Francisco, California, August 4, 2022 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported second quarter 2022 financial results and recent portfolio and business updates. As of June 30, 2022, Alector’s cash, cash equivalents and investments totaled $808.9 million.
Commentary on the Quarter:
“We continue to make significant progress in building our pipeline of novel immuno-neurology and immuno-oncology drug candidates which engage the innate immune system to treat neurodegeneration and cancer,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector.
“With the recent submission of an Investigational New Drug Application (IND) for our next first-in-class clinical drug candidate, AL044, Alector continues to build its position as an innovator in developing new approaches to tackle Alzheimer’s disease (AD) and other serious neurodegenerative disorders. The company is planning its first AL044 study in healthy volunteers. AL044 modulates MS4A, which is a genetic risk locus for AD and an immune checkpoint expressed on microglia cells. MS4A activity is associated with multiple AD pathologies, including: Abeta and Tau accumulation, earlier age of onset, and increased rate of cognitive decline. We believe that AL044 has significant potential to be effective in the treatment of AD.”
“Patient enrollment is progressing in INVOKE-2, a Phase 2 study of AL002, which is our first-in-class anti-TREM2 antibody for early AD. Following a voluntary exclusion of APOE e4/e4 homozygous patients, we have not observed additional serious adverse events related to amyloid-related imaging abnormalities (ARIA). We are implementing earlier patient monitoring to the trial that is consistent with recently published guidelines for ARIA monitoring and management as we continue to prioritize patient safety. TREM2 is an important risk gene for AD and is believed to control the survival, function, proliferation, and migration of microglia, the brain’s immune cells.”
Alector Reports Second Quarter 2022 Financial Results
Page 2
“In addition to our robust AD portfolio, we are opening additional sites and expanding recruitment efforts to enroll our Phase 3 INFRONT-3 pivotal study of latozinemab for frontotemporal dementia (FTD) with progranulin mutations (FTD-GRN). Later this year, we also expect to share new data from the Phase 1 study of AL101, the second product candidate from the company’s progranulin portfolio.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, “We are pleased to announce that the company has completed IND enabling studies for our immuno-oncology program, AL009, and anticipates submitting an IND in 2022. AL009 is a first-in-class multi Siglec inhibitor that works to enhance both the innate and adaptive immune system response to tumors by blocking a critical glycan checkpoint pathway that drives immune inhibition. As a leader in targeting myeloid biology, this brings us closer to achieving our goal of building a portfolio of innate immuno-oncology therapies by utilizing the company’s expertise in the central and peripheral innate immune system.”
“Alongside these encouraging clinical updates, Alector continues to attract world class talent and we are delighted to announce that Peter Heutink, Ph.D., will be joining us as Chief Scientific Officer. Peter brings considerable experience in human genetics of neurodegenerative diseases, functional genomics, and induced pluripotent stem cell (iPSC) technology that will help drive science and discovery at Alector.”
Clinical Programs
Immuno-Neurology Portfolio
Progranulin Assets (Latozinemab, AL101)
TREM2 and SIGLEC 3 Assets (AL002, AL003)
Alector Reports Second Quarter 2022 Financial Results
Page 3
Novel MS4A Asset (AL044)
Immuno-Oncology Portfolio
SIRPα and Multi-Siglec Assets (AL008, AL009)
Recent Corporate Updates
Alector Reports Second Quarter 2022 Financial Results
Page 4
Second Quarter 2022 Financial Results
Revenue. Collaboration revenue for the quarter ended June 30, 2022, was $79.9 million, compared to $6.6 million for the same period in 2021. The increase of $73.3 million was due to a $52.0 million net increase to collaboration revenue under the AbbVie Agreement due to changes in estimated costs to satisfy the performance obligations resulting from the termination of the AL003 program, partially offset by increases in total expected costs for the AL002 program. The increase was also due to a $21.3 million increase in revenue recognized from the GSK Agreement.
R&D Expenses. Total research and development expenses for the quarter ended June 30, 2022, were $54.5 million, compared to $47.8 million for the quarter ended June 30, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses, including stock-based compensation, as well as an increase in AL101 expenses.
G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2022, were $15.8 million, compared to $14.1 million for the same period in 2021. The increase was primarily due to an increase in personnel-related expenses, including stock-based compensation, offset by reduced legal expenses mainly to support the GSK collaboration deal in 2021.
Alector Reports Second Quarter 2022 Financial Results
Page 5
Net Income (Loss). For the quarter ended June 30, 2022, Alector reported net income of $9.9 million, or $0.12 net income per share, compared to a net loss of $55.1 million, or $0.69 net loss per share, for the same period in 2021.
Cash Position. Cash, cash equivalents, and investments were $808.9 million as of June 30, 2022. Management anticipates that this will be sufficient to fund current operations into the second half of 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 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 Quarterly Report on Form 10-Q, as filed on August 4, 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.
Alector Reports Second Quarter 2022 Financial Results
Page 6
Selected Consolidated Balance Sheet Data
(in thousands)
|
|
June 30, |
|
December 31, |
||
|
|
2022 |
|
2021 |
||
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities |
|
$ |
808,855 |
|
$ |
735,251 |
Total assets |
|
|
889,672 |
|
|
814,658 |
Total current liabilities (excluding deferred revenue) |
|
|
42,415 |
|
|
48,752 |
Deferred revenue (including current portion) |
|
|
520,893 |
|
|
425,218 |
Total liabilities |
|
|
601,156 |
|
|
513,934 |
Total stockholders’ equity |
|
|
288,516 |
|
|
300,724 |
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Collaboration revenue |
|
$ |
79,851 |
|
|
$ |
6,568 |
|
|
$ |
104,325 |
|
|
$ |
10,678 |
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
54,534 |
|
|
|
47,818 |
|
|
|
107,577 |
|
|
|
93,551 |
|
General and administrative |
|
|
15,842 |
|
|
|
14,075 |
|
|
|
31,396 |
|
|
|
25,087 |
|
Total operating expenses |
|
|
70,376 |
|
|
|
61,893 |
|
|
|
138,973 |
|
|
|
118,638 |
|
Income (loss) from operations |
|
|
9,475 |
|
|
|
(55,325 |
) |
|
|
(34,648 |
) |
|
|
(107,960 |
) |
Other income, net |
|
|
1,450 |
|
|
|
178 |
|
|
|
1,714 |
|
|
|
642 |
|
Net income (loss) before income tax |
|
|
10,925 |
|
|
|
(55,147 |
) |
|
|
(32,934 |
) |
|
|
(107,318 |
) |
Income tax expense |
|
|
1,042 |
|
|
|
|
|
|
|
1,800 |
|
|
|
|
|
Net income (loss) |
|
$ |
9,883 |
|
|
$ |
(55,147 |
) |
|
$ |
(34,734 |
) |
|
$ |
(107,318 |
) |
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic net income (loss) per share |
|
$ |
0.12 |
|
|
$ |
(0.69 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.35 |
) |
Diluted net income (loss) per share |
|
$ |
0.12 |
|
|
$ |
(0.69 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.35 |
) |
Weighted-average shares used in calculating: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic net income (loss) per share |
|
|
82,394,784 |
|
|
|
79,790,036 |
|
|
|
82,248,880 |
|
|
|
79,598,188 |
|
Diluted net income (loss) per share |
|
|
82,588,368 |
|
|
|
79,790,036 |
|
|
|
82,248,880 |
|
|
|
79,598,188 |
|
Alector Contacts:
Martin Forrest
VP, Investor Relations & Corporate Affairs
415-231-5668
martin.forrest@alector.com
1AB (media)
Dan Budwick
Alector Reports Second Quarter 2022 Financial Results
Page 7
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Eric Kasper/Carrie McKim
Argot Partners
212.600.1902
alector@argotpartners.com