ALEC 8-K
Alector, Inc. (ALEC)
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 May 4, 2023, Alector, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2023. 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: |
May 4, 2023 |
By: |
/s/ Arnon Rosenthal |
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Arnon Rosenthal, Ph.D. |
Exhibit 99.1
Alector Reports First Quarter 2023 Financial Results and Provides Business Update
On track to engage with regulatory authorities on the pivotal Phase 3 INFRONT-3 clinical trial of latozinemab in mid-2023; targeting data readout in early 2025
Plan to present additional results from the entire FTD-C9orf72 cohort in the INFRONT-2 Phase 2 clinical trial of latozinemab during the second half of 2023
Anticipate completing 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
$669.3 million in cash, cash equivalents and investments provide runway through 2025
South San Francisco, Calif., May 4, 2023 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported first quarter 2023 financial results and recent portfolio and business updates. As of March 31, 2023, Alector’s cash, cash equivalents and investments totaled $669.3 million.
“We continue the momentum built in 2022, making steady progress in the first quarter advancing our late-stage immuno-neurology programs,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We remain on track to engage with regulatory authorities this summer regarding the INFRONT-3 trial of latozinemab, and we are targeting early 2025 for a data readout from the pivotal trial. As we look ahead to the remainder of 2023, we anticipate important milestones across our pipeline, including completing enrollment in the Phase 2 clinical trial of our TREM2 candidate, AL002, in patients with early Alzheimer’s disease and new data from the INFRONT-2 clinical trial of latozinemab in FTD-C9orf72. I look forward to providing updates on our late-stage clinical and early research programs in the coming months.”
Gary Romano, M.D., Ph.D., Chief Medical Officer of Alector added, “We have an exciting year ahead of us as we continue to progress latozinemab, AL101 and AL002 through the clinic. We are very encouraged by recent drug development programs in neurological disorders that have successfully leveraged treatment effects on biomarkers to support clinical efficacy. All our clinical studies are designed to deliver robust biomarker and clinical data that will evaluate the therapeutic effects of our antibody candidates on disease pathophysiology and clinical disease progression. In our Phase 2 INFRONT-2 trial of latozinemab, we have observed normalization of CSF and plasma levels of GFAP. Increased levels of GFAP are associated with faster rates of brain atrophy in FTD. We look forward to sharing additional data from the FTD-C9orf72 cohort later this year, and we continue to advance our pivotal Phase 3 INFRONT-3 study, which evaluates those biomarkers and clinical endpoints in a double-blinded, randomized, placebo-controlled trial of latozinemab for the treatment of FTD-GRN.”
Alector Reports First Quarter 2023 Financial Results and Provides Business Update
Page 2
Recent Clinical Updates
Immuno-Neurology Portfolio
Progranulin Programs (latozinemab (AL001) and AL101) Being Developed in Collaboration with GSK
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie
Alector Reports First Quarter 2023 Financial Results and Provides Business Update
Page 3
Early Research Pipeline
Recent Corporate Updates
First Quarter 2023 Financial Results
Revenue. Collaboration revenue for the quarter ended March 31, 2023, was $16.5 million, compared to $24.5 million for the same period in 2022. This decrease was primarily due to less revenue recognized from the GSK agreement.
R&D Expenses. Total research and development expenses for the quarter ended March 31, 2023, were $51.9 million, compared to $53.0 million for the same period in 2022. The decrease in R&D expenses was mainly driven by the decrease in our latozinemab programs due to the timing of manufacturing activities offset by an increase in the AL002 program due to higher enrollment activities and the addition of the LTE trial.
G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2023, were $14.8 million, compared to $15.6 million for the same period in 2022 mainly driven by a decrease in consulting expenses related to accounting, recruiting, IT, and other general expenses.
Net Loss. For the quarter ended March 31, 2023, Alector reported a net loss of $45.9 million, or $0.55 per share, compared to a net loss of $44.6 million, or $0.54 per share, for the same period in 2022.
Cash Position. Cash, cash equivalents, and investments were $669.3 million as of March 31, 2023. Management expects that this will be sufficient to fund current 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.
Alector Reports First Quarter 2023 Financial Results and Provides Business Update
Page 4
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. 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, including the proposed timing on engagement with regulatory authorities for certain product candidates, 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 filed on May 4, 2023 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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March 31, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents, and marketable securities |
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$ |
669,329 |
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712,851 |
Total assets |
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748,342 |
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787,648 |
Total current liabilities (excluding deferred revenue) |
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37,527 |
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45,578 |
Deferred revenue (including current portion) |
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492,852 |
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491,601 |
Total liabilities |
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565,327 |
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573,206 |
Total stockholders’ equity |
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183,015 |
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214,442 |
Alector Reports First Quarter 2023 Financial Results and Provides Business Update
Page 5
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Collaboration revenue |
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$ |
16,549 |
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$ |
24,474 |
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Operating expenses: |
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Research and development |
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51,887 |
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53,043 |
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General and administrative |
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14,777 |
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15,554 |
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Total operating expenses |
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66,664 |
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68,597 |
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Loss from operations |
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(50,115) |
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(44,123) |
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Other income, net |
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5,159 |
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264 |
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Loss before income tax |
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(44,956) |
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(43,859) |
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Income tax expense |
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901 |
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758 |
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Net loss |
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$ |
(45,857) |
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$ |
(44,617) |
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Net loss per share, basic and diluted |
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$ |
(0.55) |
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$ |
(0.54) |
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Shares used in computing net loss per share basic and diluted |
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83,102,296 |
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82,102,191 |
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Alector Contacts:
Alector
Katie Hogan
202-549-0557
1AB (media)
Dan Budwick
973-271-6085
[email protected]
Argot Partners (investors)
Laura Perry
212.600.1902
[email protected]