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8-K
false000165308700016530872022-11-082022-11-08

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 08, 2022

 

 

Alector, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38792

82-2933343

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

131 Oyster Point Blvd.

Suite 600

 

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (415) 231-5660

 

 

(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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock

 

ALEC

 

The NASDAQ Stock Market LLC

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 November 8, 2022 Alector, Inc. (the “Company”) announced its financial results for the quarter ended September 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

Press Release dated November 8, 2022

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:

November 8, 2022

By:

/s/ Arnon Rosenthal

 

 

 

Arnon Rosenthal, Ph.D.
Co-founder and Chief Executive Officer

 

 
EX-99.1

Exhibit 99.1

 

 

Alector Reports Third Quarter 2022 Financial Results and Provides Business Update

 

Progressing enrollment in the INFRONT-3 Phase 3 pivotal study for latozinemab (AL001) and in the INVOKE-2 Phase 2 study for AL002

Initiated first-in-human Phase 1 trial of AL044, the company’s third novel, first-in-class clinical stage microglia immune checkpoint therapy for the treatment of Alzheimer’s disease (AD)

$758.3 million in cash, cash equivalents and investments provide runway through 2024

 

South San Francisco, Calif., November 8, 2022 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology and innate immuno-oncology, today reported third quarter 2022 financial results and recent portfolio and business updates. As of September 30, 2022, Alector’s cash, cash equivalents and investments totaled $758.3 million.

 

Commentary on the Quarter:

“In the third quarter, we expanded our first-in-class clinical immuno-neurology pipeline with AL044, a biologic targeting MS4A, a brain immune checkpoint molecule and a genetic risk factor for Alzheimer’s disease. We also continued to advance our INFRONT-3 Phase 3 pivotal study of latozinemab for frontotemporal dementia with progranulin mutations, or FTD-GRN, and our INVOKE-2 Phase 2 Alzheimer’s disease study with AL002, which activates TREM2 receptor signaling,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We will be reporting new data from the Phase 1 study of AL101 later this year at CTAD in addition to follow-up data from the INFRONT-2 Phase 2 trial in patients with symptomatic FTD-C9orf72 in 2023.”

“We anticipate biomarker data from the AL044 healthy volunteer study and completion of enrollment in our INVOKE-2 study in 2023. We believe that our immuno-neurology drug candidates, which are designed to regulate key aspects of microglial proliferation, survival, migration, lysosomal function and immune response, could prove important in effectively treating neurodegeneration 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, “Our immuno-oncology pipeline continues to advance as well. We remain on track to submit an IND for AL009, Alector’s first-in-class multi-Siglec inhibitor, by the end of the year.”

“We are also thrilled to have expanded our talented leadership team over the past quarter as we welcomed Peter Heutink, Ph.D., as Chief Scientific Officer,” said Dr. Kenkare-Mitra. “Peter’s expertise in the human genetics of neurodegenerative disease is important to our efforts at Alector.”

 

 

 

 

 

 

 

 

Alector Reports Third Quarter 2022 Financial Results

Page 2

Clinical Programs

 

Immuno-Neurology Portfolio

Progranulin Assets (Latozinemab, AL101)

•
Enrollment is ongoing globally in the INFRONT-3 randomized, placebo-controlled, pivotal Phase 3 trial evaluating the efficacy and safety of latozinemab (AL001) in at-risk and symptomatic patients with FTD-GRN. The first patient has been enrolled in the open-label extension study.

 

•
The company expects to report follow-up data from the INFRONT-2 Phase 2 clinical trial of latozinemab in frontotemporal dementia patients with a C9orf72 genetic mutation (FTD-C9orf72) in 2023.

 

•
Alector will present a poster, Repeat IV and SC dosing of the Anti-Sortilin Antibody AL101, with data from the Phase 1 trial of AL101 in healthy volunteers at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held in San Francisco, California from November 29 to December 2, 2022. AL101 is intended to elevate progranulin levels in a manner similar to latozinemab, and the company plans to investigate AL101 for the treatment of Alzheimer’s disease (AD) and Parkinson’s disease (PD).

 

•
Latozinemab and AL101 are being developed in collaboration with GSK.

 

TREM2 Asset (AL002)

•
Enrollment in the INVOKE-2 Phase 2 study of AL002 continues. The INVOKE-2 Phase 2 clinical trial is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is being developed in collaboration with AbbVie and targets Triggering Receptor Expressed on Myeloid cells 2 (TREM2) to increase TREM2 signaling and the functionality of microglia, which are brain-specific immune cells.

 

Novel MS4A Asset (AL044)

•
The company commenced its first-in-human Phase 1 trial of AL044, the first clinical-stage drug candidate to target MS4A, a major genetic risk factor for AD and an immune checkpoint expressed on microglia. The study, initiated in September of this year, is investigating the safety profile, pharmacokinetics (PK), pharmacodynamics (PD) and target engagement of AL044 in healthy adults. Safety and biomarker data from this study are anticipated in 2023. The company views MS4A as a master inhibitory checkpoint for the brain’s immune system and believes its inhibition will activate microglia in a disease-selective manner to broadly counteract Alzheimer’s disease and potentially orphan neurodegenerative indications.

 

 

 

 

Alector Reports Third Quarter 2022 Financial Results

Page 3

Immuno-Oncology Portfolio

Multi-Siglec and SIRPα Assets (AL009, AL008)

•
Alector anticipates submitting an IND for its AL009 innate immuno-oncology program before the end of the year. The company will present a poster, Characterization of suppressive myeloid cells in solid tumors to refine disease selection in a Phase 1 study of the multi-Siglec inhibitor AL009, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held in Boston, Massachusetts and virtually from November 8 to 12, 2022. AL009 is a dual function biologic that inhibits multiple Siglec receptors on myeloid cells and simultaneously activates a stimulating receptor on the same cells. The company plans to prioritize tumor types that have immunosuppressive phenotypes and expects to study AL009 as a monotherapy and in combination with standard of care.

 

•
The company plans to utilize data and documentation from a regulatory filing previously submitted by Innovent to Chinese authorities for AL008 to support a potential IND submission in the U.S. AL008 is a novel innate immuno-oncology candidate with a dual mechanism of action, targeting SIRP-alpha (SIRPa) to inhibit the CD47- SIRPα pathway and activating Fc receptors to promote immuno-stimulatory pathways that drive anti-tumor immunity.

 

Recent Corporate Updates

•
Peter Heutink, Ph.D., began his role as Alector’s Chief Scientific Officer in October. Leveraging nearly 30 years of experience in the neurodegenerative disease space, Dr. Heutink provides scientific oversight of the company’s significant research pipeline and helps drive business strategy.

 

Third Quarter 2022 Financial Results

 

Revenue. Collaboration revenue for the quarter ended September 30, 2022, was $14.9 million, compared to $182.4 million for the same period in 2021. The decrease of $167.6 million was due to $173.4 million collaboration revenue recognized from AL001 FTD-GRN license provided as part of the GSK Agreement in 2021.

 

R&D Expenses. Total research and development expenses for the quarter ended September 30, 2022, were $48.3 million, compared to $43.1 million for the quarter ended September 30, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses as well as an increase in AL002 expenses.

 

G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2022, were $14.3 million, compared to $13.0 million for the same period in 2021. The increase is primarily due to personnel-related expenses.

 

Net Income (Loss). For the quarter ended September 30, 2022, Alector reported net loss of $46.1 million, or $0.56 net loss per share, compared to a net income of $126.6 million, or $1.56 net income per share, for the same period in 2021.

 

 

Alector Reports Third Quarter 2022 Financial Results

Page 4

Cash Position. Cash, cash equivalents, and investments were $758.3 million as of September 30, 2022. Management anticipates that this will be sufficient to fund current operations through 2024.

 

About Alector

Alector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases, and innate immuno-oncology. 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 innate 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 November 8, 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 Third Quarter 2022 Financial Results

Page 5

 

 

 

 

 

Selected Consolidated Balance Sheet Data

(in thousands)

 

 

 

September 30,

 

December 31,

 

 

2022

 

2021

 

 

 

 

 

 

 

Cash, cash equivalents, and marketable securities

 

$

758,306

 

$

735,251

Total assets

 

 

837,038

 

 

814,658

Total current liabilities (excluding deferred revenue)

 

 

41,205

 

 

48,752

Deferred revenue (including current portion)

 

 

506,041

 

 

425,218

Total liabilities

 

 

583,934

 

 

513,934

Total stockholders’ equity

 

 

253,104

 

 

300,724

 

Consolidated Statement of Operations Data

(in thousands, except share and per share data)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Collaboration revenue

 

$

14,852

 

 

$

182,413

 

 

$

119,177

 

 

$

193,091

 

Operating expense:

 

 

 

 

 

 

 

 

 

 

 

 

     Research and development

 

 

48,348

 

 

 

43,066

 

 

 

155,925

 

 

 

136,617

 

     General and administrative

 

 

14,252

 

 

 

13,018

 

 

 

45,648

 

 

 

38,015

 

           Total operating expenses

 

 

62,600

 

 

 

56,084

 

 

 

201,573

 

 

 

174,722

 

Income (loss) from operations

 

 

(47,748)

 

 

 

126,329

 

 

 

(82,396

)

 

 

18,369

 

Other income, net

 

 

2,333

 

 

 

268

 

 

 

4,047

 

 

 

910

 

Net income (loss) before income tax

 

 

(45,415)

 

 

 

126,597

 

 

 

(78,349

)

 

 

19,279

 

Income tax expense

 

 

733

 

 

 

—

 

 

 

2,533

 

 

 

—

 

Net income (loss)

 

$

(46,148)

 

 

$

126,597

 

 

$

(80,882

)

 

$

19,279

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per share

 

$

(0.56)

 

 

$

1.56

 

 

$

(0.98

)

 

$

0.24

 

Diluted net income (loss) per share

 

$

(0.56)

 

 

$

1.49

 

 

$

(0.98

)

 

$

0.23

 

Weighted-average shares used in calculating:

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per share

 

 

82,602,842

 

 

 

80,964,701

 

 

 

82,367,936

 

 

 

80,048,758

 

Diluted net income (loss) per share

 

 

82,602,842

 

 

 

85,232,690

 

 

 

82,367,936

 

 

 

82,871,254

 

 

 

 

 

 

Alector Reports Third Quarter 2022 Financial Results

Page 6

Contacts:

1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com 

Argot Partners (investors)
Laura Perry/Carrie McKim
Argot Partners
212.600.1902
alector@argotpartners.com