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Dec 31, 2023
Arvinas Q4 2023 Earnings Report
Arvinas reported its financial results for Q4 2023 and provided a corporate update.
Key Takeaways
Arvinas reported a decrease in revenue for the quarter ended December 31, 2023, with a significant adjustment due to a change in contract estimate related to the Pfizer ARV-471 Collaboration Agreement. The company highlighted progress in multiple clinical trials, including those for vepdegestrant and ARV-766, and anticipates several upcoming milestones.
Enrollment continues globally in multiple clinical studies of vepdegestrant (ARV-471) in ER+/HER2- metastatic breast cancer.
Prioritized second-generation PROTAC® AR degrader ARV-766 after updated data showed robust efficacy in tumors with all AR LBD mutations in mCRPC.
Received regulatory clearance to initiate first-in-human Phase 1 clinical trials for PROTAC® targeting BCL6 and the first neuroscience PROTAC® degrader targeting LRRK2.
Completed oversubscribed $350 million private placement co-led by EcoR1 Capital and RTW Investments LP.
Forward Guidance
Arvinas anticipates completing enrollment of the VERITAC-2 Phase 3 monotherapy trial in patients with metastatic breast cancer in the second half of 2024. They also plan to continue enrollment in other ongoing trials and initiate discussions with regulatory authorities regarding new potential clinical trials. The company believes its current cash resources are sufficient to fund planned operating expenses and capital expenditure requirements into 2027.
Positive Outlook
- Complete enrollment of the VERITAC-2 Phase 3 monotherapy trial (ClinicalTrials.gov Identifier: NCT05654623) in patients with metastatic breast cancer (2H 2024).
- Continue enrollment in the study lead-in for the VERITAC-3 Phase 3 trial of vepdegestrant and palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer.
- Continue enrollment of the ongoing Phase 1b/2 clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor (PF-07220060) (TACTIVE-K: ClinicalTrials.gov Identifier: NCT06206837).
- Continue enrollment of the ongoing Phase 1b combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (TACTIVE-U: ClinicalTrials.gov Identifiers: NCTC05548127, NCTC05573555, and NCT06125522).
- Initiate discussions with regulatory authorities for a planned Phase 3 clinical trial with ARV-766 in mCRPC (2Q 2024).
Challenges Ahead
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