AnaptysBio Files 8-K: Regulation FD & Other Events

Ticker: ANAB · Form: 8-K · Filed: Feb 12, 2025 · CIK: 1370053

Anaptysbio, Inc 8-K Filing Summary
FieldDetail
CompanyAnaptysbio, Inc (ANAB)
Form Type8-K
Filed DateFeb 12, 2025
Risk Levellow
Pages5
Reading Time6 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: disclosure, regulatory

Related Tickers: ANAB

TL;DR

ANAB filed an 8-K for Reg FD and other events on Feb 12, 2025.

AI Summary

AnaptysBio, Inc. filed an 8-K on February 12, 2025, reporting on events that occurred on or before that date. The filing pertains to Regulation FD disclosures and other events, with no specific financial transactions or material changes detailed in the provided text.

Why It Matters

This filing indicates AnaptysBio is making disclosures under Regulation FD and reporting other events, which could include updates on corporate matters or regulatory compliance.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for Regulation FD and other events, not indicating any immediate financial or operational risks.

Key Players & Entities

  • ANAPTYSBIO, INC (company) — Registrant
  • February 12, 2025 (date) — Date of Report
  • Delaware (jurisdiction) — State of Incorporation
  • 10770 Wateridge Circle, Suite 210, San Diego, CA 92121 (address) — Principal Executive Offices
  • 858-362-6295 (phone_number) — Registrant's Telephone Number

FAQ

What is the primary purpose of this 8-K filing for AnaptysBio, Inc.?

The primary purpose of this 8-K filing is for Regulation FD Disclosure and to report on Other Events.

On what date was this 8-K report filed?

This 8-K report was filed on February 12, 2025.

In which state is AnaptysBio, Inc. incorporated?

AnaptysBio, Inc. is incorporated in Delaware.

What is the principal executive office address for AnaptysBio, Inc.?

The principal executive office address is 10770 Wateridge Circle, Suite 210, San Diego, CA 92121.

What is AnaptysBio, Inc.'s telephone number?

AnaptysBio, Inc.'s telephone number is (858) 362-6295.

Filing Stats: 1,450 words · 6 min read · ~5 pages · Grade level 13.1 · Accepted 2025-02-12 08:30:37

Key Financial Figures

  • $0.001 — ch registered Common Stock, par value $0.001 per share ANAB The Nasdaq Stock Marke

Filing Documents

01. Regulation FD

Item 7.01. Regulation FD. On February 12, 2025, AnaptysBio, Inc. (" AnaptysBio " or the " Company ") issued a press release announcing top-line data from rosnilimab's Phase 2b clinical trial in rheumatoid arthritis (the "Top-Line Data"), a copy of which is attached hereto as Exhibit 99.1. On February 12, 2025, AnaptysBio presented a slide presentation regarding the Top-Line Data, a copy of which is attached hereto as Exhibit 99.2. The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. On February 12, 2025, AnaptysBio announced the Top-Line Data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA). The Phase 2b RENOIR trial is evaluating the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of rosnilimab in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs) (e.g., methotrexate). The trial enrolled 424 patients with a mean baseline disease activity score -- 28 joints (DAS-28) C-Reactive Protein (CRP) score of 5.64 and mean baseline clinical disease activity index (CDAI) score of 37.7 across the U.S., Canada and Europe, who were either biologic or targeted synthetic DMARD (b/tsDMARD) nave (n=250; 59%) or experienced (n=174; 41%). Patients classified as b/tsDMARD-experienced reported prior utilization of at least one biologic or targeted synthetic therapy, such as TNF inhibitors, B cell inhibitors, selective costimulatory modulators or JAK inhibitors. Patients were randomized to receive either 100mg of subcutaneous rosnilimab every four weeks (Q4W), 400mg Q4W, 600mg every two weeks (Q2W), or placebo. The primary endpoint was assessed at Week 12 and secondary endpoints were assessed at both Week 12 and Week 14. Following completion of the Week 14 visit, rosnilimab-treated patients who achieved CDAI low disease activity (LDA) of 10, continued their assigned treatment through Week 28 in a blinded, all-active treatment period. Efficacy Endpoints The trial achieved its primary endpoint of the mean change from baseline in DAS-28 CRP at Week 12 for all three doses of rosnilimab vs. placebo. Rosnilimab achieved statistical significance in at least one dose and numerical superiority at all doses, including once monthly administration, on key secondary endpoints of ACR20, ACR50 and CDAI LDA at Week 12, even though higher than typical p

Forward-Looking Statements

Forward-Looking Statements This Current Report contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company's clinical trials, including rosnilimab's Phase 2b clinical trial in rheumatoid arthritis at Week 28 and Phase 2 clinical trial in ulcerative colitis; and whether current trends in partial 28 Week data will be maintained once complete Week 28 data becomes available. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this report, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Exhibit Number Exhibit Title or Description 99.1 Press release is

SIGNATURES

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. AnaptysBio, Inc. Date: February 12, 2025 By: /s/ Eric Loumeau Name: Eric Loumeau Title: Chief Legal Officer

View Full Filing

View this 8-K filing on SEC EDGAR

View on ReadTheFiling | About | Contact | Privacy | Terms

Data from SEC EDGAR. Not affiliated with the SEC. Not investment advice. © 2026 OpenDataHQ.