Arvinas (ARVN) Wells Fargo 21st Annual Healthcare Conference summary

Business evolution and strategic focus

• Transitioned from technology invention to having a commercialized product, with a focus now shifting to advancing multiple clinical programs nearing key data readouts within the next 15 months.

• Four clinical programs are active: ARV-393 (BCL6 degrader in hematology), SBMA program for Kennedy's disease, ARV-102 (LRRK2 degrader for neurodegeneration), and ARV-6723 (HPK1 degrader in immuno-oncology).

• ARV-393 will have initial phase I data by year-end, focusing on T-cell lymphoma, with B-cell data and combination studies expected in 2027.

• ARV-102 completed phase I in Europe; regulatory discussions are ongoing in the US, EU, and Japan, with trial starts now targeted for 2027.

• Strategic investments are prioritized, with partnering considered for select programs; cash runway extends into the second half of 2028.

Clinical program highlights

• ARV-393 targets BCL6, aiming for high degradation (~90%) to impact tumor proliferation; initial data will focus on T-cell lymphoma, with efficacy benchmarks set at 35-40% response rates.

• Combination strategies are being explored, including with glofitamab and BCL2 inhibitors, to deepen responses and potentially displace chemotherapy.

• Safety profile for ARV-393 is being closely monitored, with cytopenias and eosinophilia as key considerations; goal is to ensure combinability with other therapies.

• ARV-102 shows strong brain target engagement and pathway modulation, with upcoming biomarker data on synaptic function and neuroinflammation.

• PSP is prioritized for ARV-102 due to genetic and biomarker rationale, with plans for a controlled study to detect functional changes within a year.

Pipeline development and regulatory outlook

• SBMA program targets the disease-causing polyQ AR protein, with phase I data expected in the first half of next year; accelerated approval strategies are under consideration.

• Biomarker-driven endpoints and early intervention are key for SBMA, with MRI and functional scales being evaluated.

• HPK1 degrader (ARV-6723) is the first immuno-oncology program, aiming to remodel the tumor microenvironment and enhance immune response.

• Regulatory feedback for ARV-102 in the US required additional chronic tox data, now submitted, with harmonization of global trial plans underway.

• Partnerships will be pursued where appropriate, especially for programs requiring extensive combination studies or with longer-term commercial horizons.