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8-K
0001653087false00016530872024-05-082024-05-08

 

 

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): May 08, 2024

 

 

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 May 8, 2024, Alector, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2024. 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 May 8, 2024

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:

May 8, 2024

By:

/s/ Arnon Rosenthal

 

 

 

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

 

 
EX-99.1
https://cdn.kscope.io/2fcfad753ed1886dac1443ad6cce8ade-img61176764_0.jpg

Exhibit 99.1

 

 

 

 

Alector Reports First Quarter 2024 Financial Results

and Provides Business Update

 

Data from INVOKE-2, evaluating the most advanced TREM2 candidate in clinical development for early Alzheimer’s disease, on track for Q4 2024

Strengthened leadership team with key appointments: Neil Berkley, M.S., M.B.A., named Chief Business Officer; Errol De Souza, Ph.D., and Mark Altmeyer, M.B.A., join Board of Directors

$562.1 million in cash, cash equivalents and investments provide runway through 2026

 

South San Francisco, Calif., May 8, 2024 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported first quarter 2024 financial results and recent portfolio and business updates. As of March 31, 2024, Alector’s cash, cash equivalents and investments totaled $562.1 million.

 

“Continuing the momentum built through the first quarter, Alector is well positioned to have an impactful year, supported by an extended cash runway that carries the company through 2026,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We are advancing our maturing pipeline, including our pivotal Phase 3 trial of latozinemab in FTD-GRN. In early Alzheimer’s disease, we are now investigating two clinical candidates. The data readout from the INVOKE-2 Phase 2 clinical trial of AL002 is expected in the fourth quarter, while enrollment continues in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. Additionally, the potential of our versatile blood-brain barrier technology, Alector Brain Carrier, to enhance brain penetrance of selected product candidates is exciting and provides opportunities to further expand our clinical pipeline for the long term. With the most advanced TREM2-activating and PGRN-modulating product candidates in clinical trials and a robust early-stage pipeline, we remain dedicated to developing medicines for individuals suffering from brain disorders.”

 

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, “In addition to these encouraging research and development updates, Alector continues to strengthen its leadership team with executive and Board appointments. We are excited to recognize the addition of Neil Berkley to our executive team as our Chief Business Officer. Neil has over 20 years of corporate development, business development and strategic planning experience, spanning large pharma to small biotechs. Additionally, we are pleased to welcome Dr. Errol De Souza and Mark Altmeyer to our Board of Directors. As our late-stage clinical

 

 

 

 

1Q24 Earnings Release Page 2

 

assets progress closer toward potential FDA approval and commercialization, we look forward to leveraging their collective experience.”

Recent Clinical Updates

 

Immuno-Neurology Portfolio

Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK

 

•
The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation (FTD-GRN) is ongoing after reaching full enrollment in October 2023. The trial has a treatment duration of 96 weeks.

 

•
Enrollment is ongoing in the PROGRESS-AD global Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer’s disease (AD), with dosing initiated in February 2024. AL101 is an investigational human monoclonal antibody (mAb) designed to block and downregulate the sortilin receptor to elevate the level of progranulin (PGRN) in the brain in a manner that is similar to latozinemab but with different pharmacokinetic (PK) and pharmacodynamic (PD) properties. Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.

 

•
Alector and GSK plan to present a poster on the design of the AL101 Phase 2 trial at the Alzheimer's Association International Conference® 2024 (AAIC®) in Philadelphia from July 28 to August 1, 2024. The poster is entitled, “PROGRESS-AD: a Phase 2 study to evaluate efficacy and safety of GSK4527226 (AL101), an anti-sortilin monoclonal antibody, in patients with early Alzheimer's disease.”

 

TREM2 Program (AL002) Being Developed in Collaboration with AbbVie

 

•
The INVOKE-2 Phase 2 clinical trial of AL002 is fully enrolled, and data from the trial are anticipated in the fourth quarter of 2024. INVOKE-2, a randomized, double-blind, placebo-controlled, dose-ranging study, is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is a novel investigational humanized mAb that binds to TREM2 to increase TREM2 signaling and, thereby, is hypothesized to improve the functionality of microglia. It is the most advanced TREM2-activating product candidate in clinical development worldwide.

 

 

 

 

 

1Q24 Earnings Release Page 3

 

•
The company expects to report baseline characteristics data from the Phase 2 trial of AL002 at a medical conference later this year, providing insights into the early AD patient population enrolled, including key baseline health metrics and disease characteristics.

 

•
AbbVie has an exclusive option to globally develop and commercialize AL002. AbbVie’s exercise of that option would prompt a $250 million payment to Alector.

 

Early Research Pipeline

 

•
Alector continues to advance Alector Brain Carrier (ABC), a proprietary, versatile blood-brain barrier (BBB) technology platform, which is being applied selectively to the company’s next-generation product candidates and research pipeline.

 

•
Alector will host a virtual research and development event on June 18, 2024, to discuss the company’s ABC technology platform. The event will include a presentation from a leading scientific expert, offering insights into emerging technologies for BBB modulation and discussing future directions and opportunities in the field. The event will be webcast live on the Investor section of the company’s website at https://investors.alector.com.

 

•
Details of the event are as follows:

Crossing the Blood-Brain Barrier: Advancing the Next Generation of Alector Neurodegenerative Therapies ​

o
June 18, 2024, at 12 pm Pacific Daylight Time / 3 pm Eastern Daylight Time

Corporate

 

•
In March 2024, Alector expanded its executive leadership team with the appointment of Neil Berkley, M.S., M.B.A., as Chief Business Officer. Mr. Berkley is responsible for driving strategic growth and maximizing partnership opportunities at the company. He brings over 20 years of extensive experience in corporate development, business development and strategic planning across a spectrum of biopharmaceutical companies.

 

•
In March 2024, Alector strengthened its Board of Directors with the appointments of Errol De Souza, Ph.D., and Mark Altmeyer, M.B.A.
o
Dr. De Souza is an esteemed leader in research and development, as well as a seasoned business executive, whose expertise is focused on the discovery and development of therapeutics targeting central nervous system (CNS) disorders.

 

 

 

 

1Q24 Earnings Release Page 4

 

o
Mr. Altmeyer has more than 35 years of experience leading successful drug development and commercialization efforts as a biopharmaceutical executive, with a focus on CNS disorders and oncology.

 

First Quarter 2024 Financial Results

 

Revenue. Collaboration revenue for the quarter ended March 31, 2024, was $15.9 million, compared to $16.5 million for the same period in 2023. The decrease was primarily due to a decrease in collaboration revenue recognized for the AL001 program.

 

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2024, were $45.2 million, compared to $51.9 million for the quarter ended March 31, 2023. The decrease was mainly driven by the Company’s prioritization on selected late-stage programs and a decrease in personnel related costs.

 

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2024, were $14.4 million, compared to $14.8 million for the quarter ended March 31, 2023.

 

Net Loss. For the quarter ended March 31, 2024, Alector reported a net loss of $36.1 million, or $0.38 per share, compared to a net loss of $45.9 million, or $0.55 net loss per share, for the same period in 2023.

 

Cash Position. Cash, cash equivalents, and investments were $562.1 million as of March 31, 2024. In January 2024, Alector further strengthened its balance sheet with the completion of a follow-on financing issuing 10,869,566 shares of its common stock for total gross proceeds of $75 million before deducting underwriting discounts and commissions and estimated offering expenses. Management expects that this will be sufficient to fund current operations through 2026.

 

2024 Guidance. Management is reiterating its guidance for the year ending 2024. The company continues to anticipate collaboration revenue to be between $60 million and $70 million, total research and development expenses to be between $210 million and $230 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 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.

 

 

 

 

1Q24 Earnings Release Page 5

 

Alector’s immuno-neurology product candidates are supported by biomarkers and seek to treat indications, including Alzheimer’s disease and genetically defined frontotemporal dementia patient populations. 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, expected benefits of Dr. De Souza’s and Mr. Altmeyer’s appointment to our Board of Directors and Mr. Berkley’s appointment as our Chief Business Officer, 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 8, 2024, 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1Q24 Earnings Release Page 6

 

Selected Consolidated Balance Sheet Data

(in thousands)

 

 

March 31,

 

December 31,

2024

2023

Cash, cash equivalents, and marketable securities

$

562,083

$

548,861

Total assets

635,494

621,827

Total current liabilities (excluding deferred revenue)

91,565

94,973

Deferred revenue (including current portion)

277,927

293,820

Total liabilities

456,587

487,669

Total stockholders’ equity

178,907

134,158

 

Consolidated Statement of Operations Data

(in thousands, except share and per share data)

 

 

 

Three Months Ended

March 31,

 

2024

2023

Collaboration revenue

$

15,893

$

16,549

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

 

45,167

 

 

51,887

 

General and administrative

14,434

14,777

Total operating expenses

 

 

59,601

 

 

66,664

 

Loss from operations

 

 

(43,708

)

 

(50,115

)

Other income, net

 

 

7,636

 

 

 

5,159

 

Loss before income taxes

 

 

(36,072)

 

 

 

(44,956)

 

Income tax expense

 

 

7

 

 

 

901

 

Net loss

$

(36,079

)

$

(45,857

)

Net loss per share, basic and diluted

 

$

(0.38

)

 

$

(0.55

)

Shares used in computing net loss

per share basic and diluted

 

 

93,810,177

 

 

 

83,102,296

 

 

 

 

 

 

 

1Q24 Earnings Release Page 7

 

Alector Contacts:

Alector

Katie Hogan

202-549-0557

katie.hogan@alector.com

 

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

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