Arvinas, Inc. Files 8-K Report

TL;DR

ARVN filed an 8-K, mostly standard stuff, check for details.

AI Summary

On January 10, 2025, Arvinas, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates Arvinas, Inc. is providing updated information to the SEC, which could include financial statements or other material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard 8-K filing notification and does not contain specific material events or financial data that would indicate a change in risk.

Key Players & Entities

• Arvinas, Inc. (company) — Registrant
• 203-535-1456 (phone_number) — Registrant's telephone number
• 06511 (zip_code) — Registrant's principal executive offices zip code

FAQ

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share ARVN The Nasdaq Stock Market

Filing Documents

• arvn-20250110.htm (8-K) — 35KB
• a2025-01x10xjpmcorporate.htm (EX-99.1) — 13KB
• a2025-01x10xjpmcorporate001.jpg (GRAPHIC) — 217KB
• a2025-01x10xjpmcorporate002.jpg (GRAPHIC) — 211KB
• a2025-01x10xjpmcorporate003.jpg (GRAPHIC) — 275KB
• a2025-01x10xjpmcorporate004.jpg (GRAPHIC) — 124KB
• 0001655759-25-000004.txt ( ) — 1322KB
• arvn-20250110.xsd (EX-101.SCH) — 2KB
• arvn-20250110_lab.xml (EX-101.LAB) — 23KB
• arvn-20250110_pre.xml (EX-101.PRE) — 13KB
• arvn-20250110_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 10, 2025, Arvinas, Inc. (the "Company"), announced updated guidance for the planned first- and second-line Phase 3 combination clinical trials for vepdegestrant in patients with locally advanced or metastatic estrogen receptor ("ER") positive ("ER+")/human epidermal growth factor receptor 2 ("HER2") negative ("HER2-"; "ER+/HER2-") breast cancer, certain upcoming milestones anticipated in 2025 and provided a corporate update. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference. The information in this Item 7.01, including Exhibit 99.1 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 in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events. On January 10, 2025, the Company announced updated guidance for the planned first- and second-line Phase 3 combination clinical trials for vepdegestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer, certain upcoming milestones anticipated in 2025 and provided a corporate update. Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera ("PROTAC") ER degrader designed to harness the body's natural protein disposal system to specifically target and degrade the ER and is being co-developed by the Company and Pfizer, Inc. ("Pfizer"). The Company is on track to announce, along with Pfizer, topline data for the VERITAC-2 Phase 3 monotherapy clinical trial in patients with second-line-plus ER+/HER2- metastatic breast cancer ("mBC") in the first quarter of 2025. In addition, as part of the Company's global collaboration with Pfizer, in 2025, pending emerging data and regulatory feedback, the companies plan to initiate two new Phase 3 combination trials of vepdegestrant in patients with ER+/HER2- mBC: a first-line Phase 3 combination clinical trial with Pfizer's novel investigational CDK4 inhibitor, atirmociclib; and a second-line Phase 3 combination clinical trial with a CDK4/6 inhibitor. With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 clinical trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in. The Company also announced that it recently initiated a Phase 1 clinical trial with PROTAC leucine-rich repeat kinase 2 ("LRRK2") protein degrader ARV-102 in patients with Parkinson's disease and that, in 2025, the Company plans to: present single-ascending dose data from the ongoing Phase 1 clinical trial of ARV-102 in healthy volunteers in an oral session at the Alzheimer's Disease/Parkinson's Disease conference in Vienna, Austria, taking place from April 1-4, 2025; comp

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential plans related to and timing of initiation of clinical trials and presentation of data from clinical trials of vepdegestrant, ARV-393 and ARV-102 as well as filing of an IND for the Company's KRAS G12D degrader. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Company's strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The word "plan," and similar expressions are intended to identify forward-looking

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. Exhibit Number Description of Exhibit 99.1 Press Release, dated January 10, 2025 104 Cover Page Interactive Data File (formatted as Inline XBRL)

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 hereunto duly authorized. ARVINAS, INC. Date: January 10, 2025 By: /s/ Andrew Saik Andrew Saik Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR