ALEC Alector Inc

 

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): August 07, 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:

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On August 7, 2024, Alector, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 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 August 7, 2024
104	Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document).

 

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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 7, 2024	By:	/s/ Arnon Rosenthal
			Arnon Rosenthal, Ph.D. Co-founder and Chief Executive Officer

 

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Alector Reports Second Quarter 2024 Financial Results and Provides Business Update

 

Data from INVOKE-2 Phase 2 clinical trial of AL002 in individuals with early Alzheimer’s disease (AD) on track for Q4 2024

Patient baseline characteristics data for the INVOKE-2 trial confirm the intended study population for testing the effects of AL002, a novel TREM2 agonist, in early AD

The latozinemab pivotal INFRONT-3 Phase 3 trial continues to progress well, supported by a recent U.S. Food and Drug Administration interaction post Breakthrough Therapy Designation

$503.3 million in cash, cash equivalents and investments provide runway through 2026

Management to host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

South San Francisco, Calif., August 7, 2024 -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported second quarter 2024 financial results and recent portfolio and business updates. As of June 30, 2024, Alector’s cash, cash equivalents and investments totaled $503.3 million.

 

“Alector’s significant progress in recent months has set the stage for a transformative period ahead, as we approach key clinical catalysts for our maturing, potential first-in-class immuno-neurology programs,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We remain on track to report data from INVOKE-2, our Phase 2 clinical trial in early Alzheimer’s disease for AL002, in the fourth quarter, and we are encouraged that the recently reported patient baseline characteristics reflect a study population appropriate for the clinical evaluation of a TREM2 agonist in this indication.”

 

Dr. Rosenthal continued, “In addition, the recent Breakthrough Therapy Designation for latozinemab in frontotemporal dementia with a progranulin gene mutation has provided the opportunity for increased interactions with the FDA about this program, and we now have additional clarity on how key biomarkers may support our path to a potential regulatory submission. In parallel, we are continuing to enroll patients in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226. With a cash runway that extends through 2026, we are in a strong financial position as we approach these key milestones.”

 

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector added, “In June, Alector hosted a virtual research and development event focused on the Alector Brain Carrier (ABC), our proprietary, versatile blood-brain barrier technology. We believe our ABC technology platform has the potential to deliver novel drugs safely into the CNS, enabling potential

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best-in-class therapeutics for patients suffering from neurological disorders. We look forward to providing updates on our progress in the future.”

 

Recent Clinical Updates

 

Immuno-Neurology Portfolio

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

 

 

 

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TREM2 Program (AL002) Being Developed in Collaboration with AbbVie

 

 

 

 

Early Research Pipeline

 

 

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Second Quarter 2024 Financial Results

 

Revenue. Collaboration revenue for the quarter ended June 30, 2024, was $15.1 million, compared to $56.2 million for the same period in 2023. The decrease was mainly due to a $35.7 million decrease in revenue recognized for the AL101 programs, including a cumulative non-cash revenue adjustment due to a contract modification in the second quarter of 2023 to have GSK operationalize the AL101 Phase 2 study. The decrease is partially due to a $15.2 million decrease in revenue recognized for the AL002 program due to the addition of AL002 LTE and patient replacement revenue in 2023. This was offset by a $9.8 million increase in revenue recognized for the latozinemab programs.

 

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2024, were $46.3 million, compared to $46.2 million for the quarter ended June 30, 2023. The increase was mainly driven by the Company’s prioritization on selected late-stage programs.

 

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2024, were $14.4 million, compared to $13.6 million for the quarter ended June 30, 2023.

 

Net Income (Loss). For the quarter ended June 30, 2024, Alector reported a net loss of $38.7 million, or $0.40 per share, compared to a net income of $1.4 million, or $0.02 net income per share, for the same period in 2023.

 

Cash Position. Cash, cash equivalents, and investments were $503.3 million as of June 30, 2024. Management expects that this will be sufficient to fund current operations through 2026.

 

2024 Guidance. The Company continues to anticipate collaboration revenue to be between $60 million and $70 million. Management has updated its total research and development expenses to be between $210 million and $220 million and reiterated total general and administrative expenses to be between $60 million and $70 million.

 

Second Quarter 2024 Conference Call

 

Alector’s management team will host a conference call discussing Alector’s results for the second quarter of 2024 and provide a business update. The conference call will be webcast and accessible via the investor relations section of Alector’s website at www.alector.com.

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To access the call, please use the following information:

 

Date: Wednesday, August 7, 2024

Time: 4:30 p.m. ET, 1:30 p.m. PT

 

The event will be webcast live under the investor relations section of Alector’s website at https://investors.alector.com/events-and-presentations/events, and following the event, a replay will be archived there for 30 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone.

 

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 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, blood-brain barrier technology platform, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for INVOKE-2 and INFRONT-3, expected milestones, expectations of our collaborations, expectations of our interactions with regulatory authorities, 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 August 7, 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

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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)

 

 

		June 30,			December 31,
		2024			2023
Cash, cash equivalents, and marketable securities		$	503,334		$	548,861
Total assets			570,729			621,827
Total current liabilities (excluding deferred revenue)			83,721			94,973
Deferred revenue (including current portion)			263,544			293,820
Total liabilities			420,162			487,669
Total stockholders’ equity			150,567			134,158

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Consolidated Statement of Operations Data

(in thousands, except share and per share data)

 

 

 

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
Collaboration revenue		$	15,083			$	56,214			$	30,976			$	72,763
Operating expense:
Research and development			46,314				46,177				91,481				98,064
General and administrative			14,375				13,626				28,809				28,403
Total operating expenses			60,689				59,803				120,290				126,467
Loss from operations			(45,606)				(3,589)				(89,314)				(53,704)
Other income, net			7,003				6,357				14,639				11,516
Income (loss) before income tax			(38,603)				2,768				(74,675)				(42,188)
Income tax expense			73				1,393				80				2,294
Net income (loss)		$	(38,676)			$	1,375			$	(74,755)			$	(44,482)
Net income (loss) per share:
Net income (loss) per share, basic		$	(0.40)			$	0.02			$	(0.78)			$	(0.53)
Net income (loss) per share, diluted		$	(0.40)			$	0.02			$	(0.78)			$	(0.53)
Weighted averages shares used in calculating: Shares used in computing net income (loss) per share, basic			96,674,921				83,497,125				95,242,548				83,186,052
Shares used in computing net income (loss), per shares, diluted			96,674,921				83,566,293				95,242,548				83,186,052

 

 

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

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v3.24.2.u1

Document And Entity Information	Aug. 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 07, 2024
Entity Registrant Name	Alector, Inc.
Entity Central Index Key	0001653087
Entity Emerging Growth Company	false
Entity File Number	001-38792
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-2933343
Entity Address, Address Line One	131 Oyster Point Blvd.
Entity Address, Address Line Two	Suite 600
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(415)
Local Phone Number	231-5660
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	ALEC
Security Exchange Name	NASDAQ

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