On November 5, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.
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"The third quarter was marked by meaningful pipeline progress and strategic decisions aimed at positioning the company for sustained long-term growth and value creation," said John Houston, Ph.D., Chairperson, Chief Executive Officer, and President of Arvinas. "We have entered the beginning of a data-rich period with multiple readouts from our early-stage clinical programs. We also presented the first preclinical data from ARV-027, our promising new clinical candidate that targets the root cause of spinal bulbar muscular atrophy. Looking ahead, our mission is clear: to drive innovation across our PROTAC degrader portfolio and deliver transformative therapies to patients."
3Q 2025 Business Highlights and Recent Developments
ARV-102: Oral PROTAC LRRK2 degrader
Presented positive data from two Phase 1 clinical trials in an oral session at the International Congress of Parkinson’s Disease and Movement Disorders.
In single ascending and multiple ascending doses in healthy volunteers, ARV-102 was generally well tolerated at single doses up to 200 mg and multiple daily doses up to 80 mg, with no discontinuations due to adverse events (AEs) or serious adverse events (SAEs) observed in the study population. ARV-102 showed:
Increased exposure in a dose-dependent manner in plasma and cerebrospinal fluid (CSF), the latter indicating brain penetration.
Greater than 90% reductions of LRRK2 protein in peripheral blood mononuclear cells (PBMCs) and greater than 50% reductions in CSF (repeated daily doses ≥20 mg).
Reduced plasma concentrations of phospho-Rab10T73 and urine concentrations of bis(monoacylglycerol)phosphate (BMP), a sensitive biomarker for modulation of the lysosomal pathway downstream of LRRK2 (repeated daily doses).
Significant decreases in lysosomal pathway markers and neuroinflammatory microglial markers previously shown to be elevated in patients with Parkinson’s disease harboring LRRK2 variants as measured by unbiased proteomic analysis of CSF (ARV-102 80 mg once daily for 14 days).
To the Company’s knowledge, this is the first time an investigational LRRK2 therapy has, at 14 days in healthy volunteers, shown effects on distal pathway biomarkers in CSF that are elevated in patients with Parkinson’s disease.
In the ongoing single ascending dose trial in patients with Parkinson’ disease, single doses of ARV-102 (50 mg or 200 mg) were well tolerated with only mild treatment-related AEs including headache, diarrhea, and nausea; no SAEs occurred. ARV-102 showed:
Dose-dependent increases in exposure in both plasma and CSF, the latter indicating brain penetration.
Median PBMC LRRK2 protein reductions of 86% with the 50 mg dose and 97% with the 200 mg dose.
Initiated the multiple dose cohort of the Phase 1 clinical trial in patients with Parkinson’s disease.
ARV-393: Oral PROTAC BCL6 degrader
Announced there have been multiple responses in early cohorts of both B-and T-cell lymphomas in the first-in-human Phase 1 trial in patients with non-Hodgkin lymphoma (NHL). The anticipated effective exposure level has not been achieved, and dose escalation in the trial is ongoing (ClinicalTrials.gov Identifier: NCT06393738).
ARV-806: Novel PROTAC KRAS G12D degrader
Presented new preclinical data at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) highlighting its high potency and clear differentiation from both KRAS inhibitors and degraders currently in the clinic while also demonstrating:
Dose-dependent, selective, robust anti-tumor activity, with regressions across preclinical models of KRAS G12D-mutant cancers.
In vitro potency approximately 25 times greater than KRAS inhibitors and 40 times greater than the leading clinical-stage degrader.
Degradation >90% for 7 days after single dose and significant efficacy in models of pancreatic, colorectal, and lung cancer.
Initiated Phase 1 trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
ARV-027: Oral PROTAC polyQ-AR degrader
Presented new preclinical data at the International Congress of the World Muscle Society demonstrating induced robust degradation of polyQ-AR in human myotubes derived from spinal bulbar muscular atrophy (SBMA) patient-induced pluripotent stem cells, as well as:
Dose-dependent degradation of polyQ-AR in mouse muscle that was sustained for more than 24 hours (single oral dose).
Reductions in muscle monomeric polyQ-AR levels between 40-60%, improved muscle grip strength, and restored muscle endurance to wild-type levels in an SBMA mouse model.
Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies:
Announced the U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for vepdegestrant for the treatment of estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.
Announced agreement with Pfizer to jointly select a third party for the commercialization and potential further development of vepdegestrant, with the goal of rapidly bringing it to patients, if approved.
Presented new patient-reported outcomes data from the Phase 3 VERITAC-2 clinical trial and Phase 2 results from the TACTIVE-N clinical trial at the 2025 European Society for Medical Oncology Congress:
Patient-reported outcomes data from the VERITAC-2 clinical trial highlighted that patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains versus those who received fulvestrant.
The TACTIVE-N clinical trial, which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer, showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.
Anticipated Upcoming Milestones and Expectations
ARV-102: Oral PROTAC LRRK2 degrader
Initiate Phase 1b clinical trial in patients with progressive supranuclear palsy (1H 2026).
Present initial data from the multiple dose cohort of the Phase 1 clinical trial in patients with Parkinson’s disease (2026).
ARV-393: Oral PROTAC BCL6 degrader
Share preclinical data in combination with glofitamab in models of aggressive high grade DLBCL at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Dec. 6-9, 2025).
Share updated clinical data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2026).
Initiate enrollment in Phase 1 clinical trial in combination with glofitamab in patients with DLBCL (2026).
ARV-806: Novel PROTAC KRAS G12D degrader
Continue enrollment in the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026).
ARV-027: Oral PROTAC polyQ-AR degrader
Initiate a first-in-human Phase 1 clinical trial in healthy volunteers, pending regulatory feedback (2026).
ARV-6723: Oral PROTAC HPK1 degrader
Present preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Nov. 8, 2025).
Initiate Phase 1 clinical trial in patients with advanced solid tumors, pending regulatory feedback (2026).
Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:
Identify and select a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of September 30, 2025, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.
Third Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2025, cash, cash equivalents, and marketable securities were $787.6 million as compared with $1,039.4 million as of December 31, 2024. The decrease in cash, cash equivalents, and marketable securities of $251.8 million for the nine months ended September 30, 2025, was primarily related to cash used in operations of $233.1 million, repurchases of our common shares under our Stock Repurchase Program of $17.8 million, the purchase of lab equipment and leasehold improvements of $1.7 million.
Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) Research and development (R&D) expenses were $64.7 million for the quarter ended September 30, 2025, as compared with $86.9 million for the quarter ended September 30, 2024. The decrease in R&D expenses of $22.2 million for the quarter was primarily due to a decrease in external expenses of $7.4 million and a decrease in compensation and related personnel expenses of $14.2 million, which are not allocated by program. External expenses include program-specific expenses, which decreased by $6.5 million, primarily driven by decreases in our vepdegestrant (ARV-471), luxdegalutamide (ARV-766), and bavdegalutamide (ARV-110) programs of $5.4 million, $4.7 million, and $2.4 million, respectively, partially offset by increases in ARV-806 of $4.3 million.
Non-GAAP R&D expenses were $56.9 million for the quarter ended September 30, 2025, as compared with $73.2 million for the quarter ended September 30, 2024, excluding $0.4 million of restructuring expense for the quarter ended September 30, 2025, and $7.4 million and $13.7 million of non-cash stock-based compensation expense for the quarters ended September 30, 2025, and 2024, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.
General and Administrative Expenses: GAAP General and administrative (G&A) expenses were $21.0 million for the quarter ended September 30, 2025, as compared with $75.8 million for the quarter ended September 30, 2024. The decrease in G&A expenses of $54.8 million for the quarter was primarily due to a decrease of $43.4 million for the termination of our laboratory and office space lease with 101 College Street LLC in August 2024, a decrease in personnel and infrastructure related costs of $7.3 million, and professional fees of $3.6 million.
Non-GAAP G&A expenses were $14.6 million for the quarter ended September 30, 2025, as compared with $64.8 million for the quarter ended September 30, 2024, excluding $0.6 million of restructuring related reversal of previously recognized expense for the quarter ended September 30, 2025, and $7.0 million and $11.0 million of non-cash stock-based compensation expenses for the quarter ended September 30, 2025, and 2024, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.
Revenue: Revenue was $41.9 million for the quarter ended September 30, 2025, as compared with $102.4 million for the quarter ended September 30, 2024. Revenue for the quarter is related to the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer and the collaboration and license agreement with Pfizer. The decrease of $60.5 million was primarily due to $76.7 million of decreased revenue from the Novartis License Agreement and the Novartis Asset Agreement, both of which were entered into during the three months ended June 30, 2024, and were completed by December 31, 2024, as the technology transfer of our ongoing and planned clinical trials of luxdegalutamide (ARV-766) were transitioned to Novartis. Revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer decreased by $3.1 million and revenue from the Bayer Collaboration Agreement decreased by $0.5 million as a result of the termination of the Bayer Collaboration Agreement in August 2024. The overall decrease was offset by the recognition of $20.0 million for achievement of a development milestone pursuant to the terms of the Novartis License Agreement.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, November 5, 2025, at 8:00 a.m. ET to review its third quarter 2025 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.
(Press release, Arvinas, NOV 5, 2025, View Source [SID1234659456])