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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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:
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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 5, 2022 Alector, Inc. (the “Company”) announced its financial results for the quarter ended March 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: May 5, 2022 |
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By: |
/s/ Arnon Rosenthal |
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Arnon Rosenthal, Ph.D. Co-founder and Chief Executive Officer |
Exhibit 99.1
Alector Reports First Quarter 2022 Financial Results and Provides Business Update
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, California, May 5, 2022 -- 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
Alector Reports First Quarter 2022 Financial Results
Page 2
Alzheimer’s Disease Portfolio
Immuno-oncology Portfolio
Alector Reports First Quarter 2022 Financial Results
Page 3
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 Reports First Quarter 2022 Financial Results
Page 4
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.
Alector Reports First Quarter 2022 Financial Results
Page 5
Selected Consolidated Balance Sheet Data
(in thousands)
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March 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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$ |
868,571 |
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$ |
735,251 |
Total assets |
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954,457 |
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814,658 |
Total current liabilities (excluding deferred revenue) |
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47,267 |
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48,752 |
Deferred revenue (including current portion) |
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600,744 |
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425,218 |
Total liabilities |
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686,920 |
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513,934 |
Total stockholders’ equity |
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267,537 |
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300,724 |
Consolidated Statement of Operations Data
(in thousands, except share and per share data)
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Three Months Ended |
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2022 |
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2021 |
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Collaboration revenue |
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$ |
24,474 |
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$ |
4,110 |
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Operating expenses: |
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Research and development |
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53,043 |
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45,733 |
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General and administrative |
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15,554 |
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11,012 |
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Total operating expenses |
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68,597 |
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56,745 |
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Loss from operations |
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(44,123 |
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(52,635 |
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Other income, net |
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264 |
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464 |
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Loss before income taxes |
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(43,859 |
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(52,171 |
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Income tax expense |
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758 |
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— |
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Net loss |
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$ |
(44,617 |
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$ |
(52,171 |
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Net loss per share, basic and diluted |
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$ |
(0.54 |
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$ |
(0.66 |
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Shares used in computing net loss per share basic and diluted |
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82,102,191 |
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79,386,836 |
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Contacts:
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Eric Kasper/Carrie McKim
Argot Partners
212.600.1902
alector@argotpartners.com