ARVINAS, INC. SEC Filings

Arvinas (ARVN) reported new preclinical results for ARV-806, a PROTAC degrader targeting the KRAS G12D mutation, presented at the 2025 AACR‑NCI‑EORTC “Triple Meeting.” The program aims at a common KRAS mutation found in pancreatic, colorectal, and non‑small cell lung cancers.

In cell studies, ARV‑806 degraded KRAS G12D with picomolar potency and spared wild‑type and other RAS isoforms. Compared with clinical‑stage KRAS G12D ON and OFF inhibitors and another clinical‑stage G12D degrader, it showed >25‑fold greater anti‑proliferative potency, >40‑fold higher degradation potency (vs the comparable degrader), and required >10‑fold lower concentrations to induce pro‑apoptotic BIM. In a colorectal tumor xenograft model, a single IV dose achieved >90% KRAS G12D degradation for seven days, with parallel c‑MYC suppression and BIM induction for ≥5 days. Tumor models showed ≥30% volume reductions across pancreatic and colorectal CDX and a lung PDX model. The company is evaluating ARV‑806 in a Phase 1 trial in KRAS G12D‑mutated advanced solid tumors.

Arvinas (ARVN) reported new patient-reported outcomes from the Phase 3 VERITAC-2 trial of vepdegestrant, presented at ESMO 2025. The company said vepdegestrant showed a reduced risk of deterioration versus fulvestrant in patients with ESR1‑mutated, ER+/HER2‑ advanced or metastatic breast cancer previously treated with endocrine therapy, with statistically significant advantages in several PRO domains including overall health status, pain severity, and role, cognitive, emotional, and social functioning.

Vepdegestrant is an investigational PROTAC estrogen receptor degrader being developed with Pfizer as a potential monotherapy for ESR1‑mutated ER+/HER2‑ disease. Arvinas also highlighted Phase 2 TACTIVE‑N results in a neoadjuvant setting for ER+/HER2‑ localized breast cancer in postmenopausal women, where vepdegestrant demonstrated biological and clinical activity. The company furnished a press release as Exhibit 99.1 and noted the information is provided under Regulation FD and Other Events.

Arvinas, Inc. presented late-breaking Phase 1 clinical data for ARV-102, a PROTAC LRRK2 degrader, showing brain penetration and strong target reduction in early trials. In healthy volunteers, single doses up to 200 mg and multiple daily doses up to 80 mg were generally well tolerated with no discontinuations for adverse events. Repeated daily doses ≥20 mg produced > 90% reductions in LRRK2 protein in blood cells and > 50% reductions in cerebrospinal fluid (CSF); pathway biomarkers (phospho-Rab10T73 and urine BMP) were reduced.

In a small Parkinson’s cohort (15 treated, 4 placebo), single doses of 50 mg and 200 mg were well tolerated with only mild treatment-related AEs. Median PBMC LRRK2 reductions were 86% at 50 mg and 97% at 200 mg. CSF proteomics after 14 days of 80 mg daily dosing in volunteers showed decreased lysosomal and neuroinflammatory markers. The company plans to present multiple-dose patient data in 2026 and intends to advance ARV-102 development.

Arvinas, Inc. director Briggs Morrison reported purchasing 30,000 shares of ARVN common stock on 09/22/2025 at a weighted average price of $7.567 per share. After the transaction, Mr. Morrison beneficially owned 76,021 shares. The filing was submitted on 09/24/2025 and signed by an attorney-in-fact.

The footnote clarifies the $7.567 figure is a weighted average for multiple purchases priced between $7.50 and $7.65; the reporting person offered to provide a breakdown of per-trade quantities on request. No derivative transactions or additional securities classes are reported on this Form 4.

Arvinas, Inc. is restructuring its business and capital allocation. Management approved a workforce reduction of approximately 15%, mainly in roles tied to vepdegestrant commercialization, and expects to incur about $4.5 million in severance and related one-time termination costs, recognized primarily in the third and fourth quarters of 2025. The reduction is expected to be largely complete in the first quarter of 2026.

Arvinas and Pfizer have jointly agreed to out-license commercialization rights to vepdegestrant to a third party and plan to limit further spending on the program while seeking a partner. The company aims to optimize costs, including an additional 15% workforce reduction and tighter pipeline spending, and believes its cash, cash equivalents and marketable securities as of June 30, 2025, plus these actions, can fund operations into the second half of 2028.

The Board also authorized a share repurchase program for up to $100 million of Arvinas common stock, to be funded from working capital and executed through various methods with no set time limit.

Logos Global and affiliated funds report owning a meaningful stake in Arvinas, Inc. The filing shows Logos Global Management and related entities jointly beneficially own 6,300,000 shares, representing 8.6% of Arvinas's outstanding common stock based on 73,417,595 shares. Logos Global Master Fund holds 5,000,000 shares (6.8%) and Logos Opportunities Fund holds 1,300,000 shares (1.8%). Purchases were made on the open market: Global Fund acquired 3,200,000 shares for $23,534,011.75 and exercised 15,000 call options on August 15, 2025 to obtain 1,500,000 shares for $7,500,000; Opportunities Fund acquired 1,300,000 shares for $10,067,317.13. The reporting persons state their purpose is investment but have actively engaged management, recommending a strategic reset including a $700 million return of capital, expense reductions, a 1-for-5 reverse stock split, and refraining from further early-stage pipeline investment absent a strategic partner.

Arvinas announced that the U.S. Food and Drug Administration has accepted the company’s new drug application for vepdegestrant, seeking treatment of patients with estrogen receptor positive (ER+)/HER2-negative disease whose tumors carry ESR1 mutations and who previously received endocrine-based therapy. The filing includes a company press release as Exhibit 99.1.

The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026, establishing the target date for the agency’s decision on the application.