# EDGAR Filing Document

**Accession Number:** 0001653087
**File Stem:** 0000950170-25-105023
**Filing Date:** 2025-8
**Character Count:** 20656
**Document Hash:** 8386ca2449d38e357672c664f7ee155d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-105023.hdr.sgml**: 20250807

**ACCESSION NUMBER**: 0000950170-25-105023

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250807

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250807

**DATE AS OF CHANGE**: 20250807

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Alector, Inc.
- **CENTRAL INDEX KEY:** 0001653087
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 822933343
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38792
- **FILM NUMBER:** 251194094

**BUSINESS ADDRESS:**
- **STREET 1:** 131 OYSTER POINT BLVD., SUITE 600
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080
- **BUSINESS PHONE:** 415-231-5660

**MAIL ADDRESS:**
- **STREET 1:** 131 OYSTER POINT BLVD., SUITE 600
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Alector LLC
- **DATE OF NAME CHANGE:** 20150915

?xml version='1.0' encoding='ASCII'? 8-K

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

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## **FORM** 8-K

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**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, 2025<br>

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Alector, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-38792 | 82-2933343 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 131 Oyster Point Blvd.<br>Suite 600 |  |  |
| South San Francisco**,** California |  | 94080 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (415) 231-5660<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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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:

☐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:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock | ALEC | The Nasdaq Stock Market LLC |

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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. ☐

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## **Item 2.02 Results of Operations and Financial Condition.** 
On August 7, 2025, Alector, Inc. (the "Company") announced its financial results for the quarter ended June 30, 2025. 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**

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [<u>Press Release dated August 7, 2025</u>](alec-ex99_1.htm) |
| 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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **ALECTOR, INC.** |
| Date: | August 7, 2025 | By:  | /s/ Arnon Rosenthal |
|  |  |  | Arnon Rosenthal, Ph.D.<br>Co-founder and Chief Executive Officer |

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## Exhibit 99.1

RELEASE

Exhibit 99.1

**Alector Reports Second Quarter 2025 Financial Results** 

**and Provides Business Update** 

*On track to report topline data by mid-Q4 2025 from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN, a severe, rare form of dementia with no approved treatments*

*Ongoing Phase 2 PROGRESS-AD trial of AL101 in early Alzheimer's disease expected to complete in 2026*

*Continuing to progress Alector Brain Carrier programs, including the company's anti-amyloid beta antibody, engineered GCase enzyme replacement therapy, and anti-tau siRNA*

*$307.3 million in cash, cash equivalents, and investments provides runway* 

*into the second half of 2027*

*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, 2025 -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today reported second quarter 2025 financial results and recent portfolio and business updates. As of June 30, 2025, Alector's cash, cash equivalents, and investments totaled $307.3 million.

"The topline results from the pivotal INFRONT-3 Phase 3 trial of latozinemab, expected by mid- fourth quarter, represent a key inflection point for Alector and for the FTD community," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "FTD is a devastating form of dementia that affects people in the prime of life, with no approved treatments, and is often fatal within a decade of diagnosis. Heterozygous loss-of-function mutations in the *GRN* gene reduce progranulin levels by about 50%, impairing neuronal function and driving neurodegeneration. Latozinemab, our investigational therapy for FTD-*GRN* being developed in collaboration with GSK, is designed to restore progranulin levels in the brain. Supported by data from an open-label Phase 2 study, the FDA granted Breakthrough Therapy designation to latozinemab. The INFRONT-3 results will inform our next steps toward potential registration and may bring us one step closer to delivering a treatment for this relentless disease."

Dr. Rosenthal continued, "In parallel, we are advancing AL101 in early Alzheimer's disease, with a placebo-controlled, double-blind, 76-week Phase 2 trial that is expected to complete in 2026. At the same time, we continue to build our preclinical and research pipeline, including brain-penetrant candidates enabled by our proprietary Alector Brain Carrier platform. Progressing late-stage clinical programs while investing in innovative early assets positions

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2Q25 Earnings Release Page 2

Alector to create near- and long-term value for both patients and shareholders. With a cash runway into the second half of 2027, we are well resourced to advance our scientific and strategic goals."

**Recent Clinical Updates** 

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

**Latozinemab** 

• Alector and GSK remain on track to report topline data by the middle of the fourth quarter of 2025 from the pivotal, 96-week, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 trial evaluating latozinemab in frontotemporal dementia due to a *GRN* gene mutation (FTD-*GRN*). Pending the trial's outcome, the companies are preparing for potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions in 2026.

• The statistical analysis plan (SAP) for INFRONT-3 has been amended after engagement with the U.S. Food and Drug Administration (FDA). The SAP will include plasma progranulin (PGRN) as a co-primary endpoint along with the Clinical Dementia Rating<sup>®</sup> plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR<sup>®</sup> plus NACC FTLD-SB).

• Frontotemporal dementia (FTD) is a rare neurodegenerative disease and the most common form of dementia for people under the age of 60.<sup>1</sup> It affects an estimated 50,000 to 60,000 individuals in the United States and roughly 110,000 in the European Union.<sup>2,3</sup> There are several heritable forms of FTD, including FTD-*GRN*, which is caused by mutations in the *GRN* gene and represents about 5% to 10% of all cases.⁴ People with FTD often begin experiencing symptoms such as behavioral changes, lapses in judgment, and diminished

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2Q25 Earnings Release Page 3

language skills in their 40s and 50s.<sup>1</sup> The disease typically progresses over 7 to 10 years and is ultimately fatal.<sup>5</sup> Currently, there are no approved treatment options for any form of FTD.<sup>1</sup>

• Heterozygous loss-of-function mutations in the *GRN* gene lead to haploinsufficiency, reducing PGRN levels in the central nervous system by 50%. These mutations are a known genetic cause of FTD.<sup>6</sup> PGRN is a secreted glycoprotein that regulates lysosomal function, neuronal survival, and inflammation in the brain.<sup>6</sup>

• Latozinemab is a novel, investigational human monoclonal antibody (mAb) designed to block and internalize the sortilin receptor to elevate PGRN levels in the brain. It is believed to be the most advanced therapeutic candidate in development for the treatment of FTD-*GRN*.

• Latozinemab has been granted Breakthrough Therapy and Fast Track designations by the FDA for the treatment of FTD-*GRN*, as well as Orphan Drug designation for the treatment of FTD from both the FDA and the European Medicines Agency.

**AL101/GSK4527226**

• The global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer's disease (AD) is ongoing, with enrollment completed in April 2025 and trial completion expected in 2026.

• AL101 is an investigational human mAb designed to block and internalize the sortilin receptor to elevate the level of PGRN in the brain. It is similar to latozinemab but has distinct pharmacokinetic and pharmacodynamic properties that may make it suitable for the potential treatment of more prevalent neurodegenerative diseases.

• In July 2025, Alector published a manuscript titled "Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer's disease" in *Alzheimer's Research & Therapy*. The publication outlines preclinical and Phase 1 study results, demonstrating that AL101 bound to sortilin and decreased cell surface sortilin levels, leading to consistent elevations of PGRN across *in vitro*, preclinical, and Phase 1 studies. These results support continued development of AL101 and its investigation as a potential treatment for AD and other neurodegenerative conditions where PGRN could play a role.

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2Q25 Earnings Release Page 4

**Preclinical and Research Pipeline**

Alector continues to advance its preclinical and early research pipeline, selectively supported by Alector Brain Carrier (ABC), the company's proprietary blood-brain barrier technology platform.

• The company is progressing ADP037-ABC, its brain-penetrant anti-amyloid beta antibody in AD; ADP050-ABC, its brain-penetrant engineered GCase enzyme replacement therapy in Parkinson's disease; and ADP064-ABC, its brain-penetrant anti-tau siRNA in AD, all of which are enabled by ABC. Alector is currently evaluating potential candidates and continues to target clinical entry for ADP037-ABC and ADP050-ABC in 2026, pending resource allocation, lead candidate selection, and the results of preclinical studies.

**Corporate News**

• Neil Berkley, M.B.A., assumed the role of Interim Chief Financial Officer in June 2025 while continuing as Chief Business Officer. With a proven track record in corporate development and business strategy, Mr. Berkley brings insightful leadership to Alector as the company advances through key clinical and research milestones in his expanded role.

• In the third quarter of 2025, the U.S. Patent and Trademark Office issued a patent covering methods of treatment using latozinemab in individuals with FTD-*GRN*.

**Second Quarter 2025 Financial Results**

**Revenue.** Collaboration revenue for the quarter ended June 30, 2025, was $7.9 million, compared to $15.1 million for the same period in 2024. The $7.2 million decrease was mainly due to the satisfaction of the performance obligation associated with the AL002 program and the latozinemab FTD-*C9orf72* Phase 2 trial in the fourth quarter of 2024.

**R&D Expenses.** Total research and development expenses for the quarter ended June 30, 2025, were $27.6 million, compared to $46.3 million for the quarter ended June 30, 2024. The decrease of $18.7 million was mainly due to a decrease in research and development expenses for the AL002 program and latozinemab program as well as a decrease in personnel related costs as a result of the reductions in force.

**G&A Expenses.** Total general and administrative expenses were $14.4 million for both the three months ended June 30, 2025, and the three months ended June 30, 2024.

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2Q25 Earnings Release Page 5

**Net Loss.** For the quarter ended June 30, 2025, Alector reported a net loss of $30.5 million, or $0.30 per share, compared to a net loss of $38.7 million, or $0.40 net loss per share, for the same period in 2024.

**Cash Position.** Cash, cash equivalents, and investments were $307.3 million as of June 30, 2025. Management anticipates that this will be sufficient to fund Alector's operations into the second half of 2027.

**2025 Guidance.** Management is updating its guidance for the year ending 2025. The company anticipates collaboration revenue to be between $13 million and $18 million, total research and development expenses to be between $130 million and $140 million, and total general and administrative expenses to be between $55 million and $65 million.

**About Alector**

Alector is a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegenerative diseases. Leveraging the principles of genetics, immunology, and neuroscience, the company is advancing a portfolio of genetically validated programs that aim to remove toxic proteins, replace missing proteins, and restore immune and nerve cell function. Supported by biomarkers, Alector's product candidates seek to treat a range of indications, such as frontotemporal dementia, Alzheimer's disease, and Parkinson's disease. The company is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its next-generation product candidates and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com.

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2Q25 Earnings Release Page 6

**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, research and preclinical pipeline, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for INFRONT-3 and PROGRESS-AD, 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, 2025, 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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| | | |
|:---|:---|:---|
|  | &nbsp;&nbsp;**June 30,**<br>&nbsp;&nbsp;**2025** | &nbsp;&nbsp;**December 31,**<br>&nbsp;&nbsp;**2024** |
| &nbsp;&nbsp;Cash, cash equivalents, and marketable securities | $&nbsp;&nbsp;307280 | $&nbsp;&nbsp;413397 |
| &nbsp;&nbsp;Total assets | &nbsp;&nbsp;356422 | &nbsp;&nbsp;468303 |
| &nbsp;&nbsp;Total current liabilities (excluding deferred revenue) | &nbsp;&nbsp;70952 | &nbsp;&nbsp;101396 |
| &nbsp;&nbsp;Deferred revenue (including current portion) | &nbsp;&nbsp;182272 | &nbsp;&nbsp;195832 |
| &nbsp;&nbsp;Total liabilities | &nbsp;&nbsp;285247 | &nbsp;&nbsp;341503 |
| &nbsp;&nbsp;Total stockholders' equity | &nbsp;&nbsp;71175 | &nbsp;&nbsp;126800 |

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**Consolidated Statement of Operations Data**

**(in thousands, except share and per share data)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended<br>June 30,** | **Three Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Collaboration revenue | $7874 | $15083 | $11548 | $30976 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp; Research and development | 27611 | 46314 | 61252 | 91481 |
| &nbsp;&nbsp;&nbsp;&nbsp; General and administrative | 14401 | 14375 | 29129 | 28809 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Total operating expenses | 42012 | 60689 | 90381 | 120290 |
| Loss from operations | (34138) | (45606) | (78833) | (89314) |
| Other income, net | 3614 | 7003 | 7838 | 14639 |
| Net loss before income tax | (30524) | (38603) | (70995) | (74675) |
| Income tax expense |  | 73 |  | 80 |
| Net loss | $(30524) | $(38676) | $(70955) | $(74755) |
| Net loss per share, basic and diluted | $(0.30) | $(0.40) | $(0.71) | $(0.78) |
| Shares used in computing net loss <br>per share basic and diluted | <br>100371632 | <br>96674921 | <br>99887605 | <br>95242548 |

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**REFERENCES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.The Association for Frontotemporal Degeneration (AFTD).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.Patient estimates based on internal forecasting analysis using published literature sources.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.E.U. estimates include EU5 countries only (Spain, Italy, France, U.K. and Germany).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.FTD Disorders Registry.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.Taylor R, Finger E. Frontotemporal dementias. *Pract Neurol*. 2019 Jun.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.Rhinn H, et al. Progranulin as a therapeutic target in neurodegenerative diseases. *Trends Pharmacol Sci.* 2022 Aug;43(8):641-652.

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**Alector Contacts**:

Alector

Katie Hogan

202-549-0557

katie.hogan@alector.com

Argot Partners (media)<br>David Rosen <br>646-461-6387

alector@argotpartners.com

Argot Partners (investors)<br>Laura Perry <br>212-600-1902<br>alector@argotpartners.com

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