Arvinas, Inc. Files 8-K Report

TL;DR

ARVINAS FILES 8-K: REGULATORY FILING WITH POTENTIAL UPDATES.

AI Summary

On May 16, 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 text.

Why It Matters

This filing indicates Arvinas, Inc. is providing updated information to the SEC, which could include financial updates or disclosures of material events relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard procedural report and does not contain information that inherently increases risk.

Key Players & Entities

• Arvinas, Inc. (company) — Registrant
• May 16, 2024 (date) — Date of earliest event reported
• 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-20240516.htm (8-K) — 41KB
• a2024-05x16xesmobreastve.htm (EX-99.1) — 28KB
• a2024-05x16xesmobreastve001.jpg (GRAPHIC) — 261KB
• a2024-05x16xesmobreastve002.jpg (GRAPHIC) — 225KB
• a2024-05x16xesmobreastve003.jpg (GRAPHIC) — 218KB
• a2024-05x16xesmobreastve004.jpg (GRAPHIC) — 236KB
• a2024-05x16xesmobreastve005.jpg (GRAPHIC) — 238KB
• a2024-05x16xesmobreastve006.jpg (GRAPHIC) — 273KB
• a2024-05x16xesmobreastve007.jpg (GRAPHIC) — 277KB
• a2024-05x16xesmobreastve008.jpg (GRAPHIC) — 71KB
• 0001655759-24-000063.txt ( ) — 2687KB
• arvn-20240516.xsd (EX-101.SCH) — 2KB
• arvn-20240516_lab.xml (EX-101.LAB) — 23KB
• arvn-20240516_pre.xml (EX-101.PRE) — 13KB
• arvn-20240516_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On May 16, 2024, Arvinas, Inc. (the "Company"), along with Pfizer, Inc. ("Pfizer"), announced updated clinical data from a Phase 1b clinical trial combination cohort evaluating vepdegestrant in combination with palbociclib (IBRANCE). Vepdegestrant is an investigational oral PROteolysis TArgeting Chimera ("PROTAC") estrogen receptor ("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 updated data (data cutoff of December 18, 2023) were presented at the 2024 European Society for Medical Oncology ("ESMO") Breast Cancer Annual Congress and represent six months of additional follow-up from data (data cutoff of June 6, 2023) presented in December 2023 at the San Antonio Breast Cancer Symposium ("SABCS"). After six months of additional follow-up, these data presented at the 2024 ESMO Breast Cancer Annual Congress are consistent with data presented at SABCS and show that vepdegestrant in combination with palbociclib continue to demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of prior therapy with locally advanced or metastatic ER positive ("ER+")/human epidermal growth factor 2 ("HER2") negative ("ER+/HER2-") breast cancer. Specifically, after six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023. A copy of the press release is attached as Exhibits 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 othe

01. Other Events

Item 8.01. Other Events. On May 16, 2024, the Company along with Pfizer announced updated clinical data from a Phase 1b clinical trial combination cohort evaluating vepdegestrant in combination with palbociclib (IBRANCE). Vepdegestrant is an investigational 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 updated data (data cutoff of December 18, 2023) were presented at the 2024 ESMO Breast Cancer Annual Congress and represent six months of additional follow-up from data (data cutoff of June 6, 2023) presented in December 2023 at SABCS. After six months of additional follow-up, updated data presented at the 2024 ESMO Breast Cancer Annual Congress are consistent with data presented at SABCS and show that vepdegestrant in combination with palbociclib continue to demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of prior therapy with locally advanced or metastatic ER+/HER2- breast cancer. Specifically, after six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023. In addition, at the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival of 13.9 months (95% CI: 8.1-NR). Further, across all vepdegestrant dose groups, circulating tumor DNA analyses showed marked reduction in tumor fraction after one treatment cycle, regardless of ESR1 gene mutation status, and at the 200 mg vepdegestrant dose, robust on-treatment decreases in mutant ESR1 circulating tumor DNA were sustained through multiple treatment cycles. The Phase 1b cohort of the ARV-471-mBC-101 study (NCT04072952) is designed t

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description of Exhibit 99.1 Press Release, dated May 16, 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: May 16, 2024 By: /s/ Randy Teel Randy Teel Interim Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR