Arvinas, Inc. Files 8-K Report

TL;DR

ARVN filed an 8-K, check for new info.

AI Summary

On December 10, 2024, 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 filing indicates Arvinas, Inc. is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

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

Key Numbers

• 001-38672 — SEC File Number (Arvinas, Inc.'s SEC filing identifier)
• 47-2566120 — IRS Employer Identification No. (Arvinas, Inc.'s tax identification number)

Key Players & Entities

• Arvinas, Inc. (company) — Registrant
• Delaware (jurisdiction) — State of incorporation
• New Haven, Connecticut (location) — Principal executive offices location

FAQ

Key Financial Figures

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

Filing Documents

• arvn-20241210.htm (8-K) — 34KB
• ex991-2024x12x10xsabcs20.htm (EX-99.1) — 18KB
• ex991-2024x12x10xsabcs20001.jpg (GRAPHIC) — 254KB
• ex991-2024x12x10xsabcs20002.jpg (GRAPHIC) — 232KB
• ex991-2024x12x10xsabcs20003.jpg (GRAPHIC) — 299KB
• ex991-2024x12x10xsabcs20004.jpg (GRAPHIC) — 295KB
• ex991-2024x12x10xsabcs20005.jpg (GRAPHIC) — 98KB
• 0001655759-24-000140.txt ( ) — 1811KB
• arvn-20241210.xsd (EX-101.SCH) — 2KB
• arvn-20241210_lab.xml (EX-101.LAB) — 23KB
• arvn-20241210_pre.xml (EX-101.PRE) — 13KB
• arvn-20241210_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 10, 2024, Arvinas, Inc. (the "Company"), along with Pfizer, Inc. ("Pfizer"), announced preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic estrogen receptor ("ER") positive ("ER+")/human epidermal growth factor receptor 2 negative ("HER2-") breast cancer. Vepdegestrant is an investigational oral 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. These data (data cut-off: August 30, 2024) will be presented in a poster at the 2024 San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, Texas on December 12, 2024. Preliminary results from 16 patients in the Phase 1b sub-study demonstrated a tolerable safety profile for the combination of abemaciclib 150 mg twice daily ("BID") with the recommended Phase 3 monotherapy dose of vepdegestrant (200mg once daily ("QD")). A clinical benefit rate ("CBR") of 62.5% was observed among patients with both mutant ESR1 and wild-type ESR1 disease who had all been previously treated with a cyclin-dependent kinase ("CDK") 4/6 inhibitor. Pharmacokinetic data demonstrated no significant drug-drug interaction between vepdegestrant and abemaciclib and no clinically meaningful effect on abemaciclib exposure was observed. In addition to tolerability, the results demonstrated a safety profile consistent with both the known properties of abemaciclib and observed data in other clinical trials for vepdegestrant. These findings support the ongoing Phase 2 portion of the study, which is evaluating full dose abemaciclib (150mg BID) in combination with vepdegestrant (200 mg QD) in post-CDK4/6 advanced breast cancer. A copy of the press release is attached as Exhibits 99.1 to this Current Report on Form 8-K and is i

01. Other Events

Item 8.01. Other Events. On December 10, 2024, the Company, along with Pfizer, announced preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/ HER2- breast cancer. Vepdegestrant is an investigational oral 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. These data (data cut-off: August 30, 2024) will be presented in a poster at the 2024 SABCS in San Antonio, Texas on December 12, 2024. Preliminary results from 16 patients in the Phase 1b sub-study demonstrated a tolerable safety profile for the combination of abemaciclib 150 mg BID with the recommended 200mg QD Phase 3 monotherapy dose of vepdegestrant. Pharmacokinetic data demonstrated no significant drug-drug interaction between vepdegestrant and abemaciclib and no clinically meaningful effect on abemaciclib exposure was observed. Below are the key findings included in the poster: 100% of patients had prior treatment with a CDK4/6 inhibitor. Tolerability is generally consistent with the profile of abemaciclib and with results previously observed in other clinical trials of vepdegestrant. The most common any grade treatment-emergent adverse events ("TEAE") were diarrhea, nausea and fatigue. There were no dose-limiting toxicities and no grade 4 or 5 TEAEs. There was no significant drug-drug interaction, and data reflected vepdegestrant has no clinically meaningful effect on abemaciclib exposure. The CBR (CBR, defined as the rate of confirmed complete response, partial response, or stable disease 24 weeks) was 62.5% in all CBR-eligible patients (10/16), 62.5% in patients with mutant ESR1 (5/8), and 62.5% in patients with wild-type ESR1 (5/8). The objective response rate in evaluable patients was 26.7% overall (4/15), 37.5% in patients with mutant ESR1 (3/8),

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description of Exhibit 99.1 Press Release, dated December 10, 2024 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: December 10, 2024 By: /s/ Andrew Saik Andrew Saik Chief Financial Officer

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View this 8-K filing on SEC EDGAR