Arvinas (ARVN) shared updates on its clinical pipeline at the Wells Fargo 21st Annual Healthcare Conference, outlining a series of data readouts expected over the next 15 months across its oncology and neurology programs.
Shares fell 2.82% to $9.13 on the day of the conference, down from a previous close of $9.39. The stock has traded between $6.97 and $14.51 over the past 52 weeks. Analysts project a 2026 EPS of -$0.27, reflecting no near-term profitability, while the company reported a gross profit margin of 97% and expects its cash runway to extend into the second half of 2028.
Arvinas CEO Randy Teel described the moment as "a time of good change for us," noting that multiple programs are approaching data inflection points. President and CEO Teel and Chief Scientific Officer Angela Casey presented alongside Wells Fargo biotech analyst Derek Archila.
Vepdegestrant, the company's first PROTAC degrader, is now commercialized by a partner and reaching patients, marking Arvinas's first marketed product exposure.
In oncology, ARV-393, a BCL6 degrader being studied in B-cell and T-cell lymphomas, is the subject of a phase I dose-escalation trial. First clinical data focusing initially on angioimmunoblastic T-cell lymphoma (AITL) are expected by the end of 2022, with B-cell lymphoma data—both as monotherapy and in combination—planned for 2027, alongside regulatory path decisions. The second-line AITL benchmark for existing therapies sits at a 35% to 40% response rate. Preclinical work suggested approximately 90% BCL6 degradation is needed to impact tumor growth and trigger apoptosis. Arvinas also has a supply agreement with Roche to study ARV-393 in combination with glofitamab, a CD20 x 3B4 bispecific antibody.
In neurodegeneration, ARV-102 targets LRRK2 for progressive supranuclear palsy (PSP), with Parkinson's disease as a longer-term indication. Phase I testing in healthy volunteers and Parkinson's patients was completed in Europe. Preclinical data indicate ARV-102 is 50 times more effective at engaging the LRRK2 pathway than existing LRRK2 inhibitors. The program showed dose-dependent reductions in endolysosomal proteins including GPNMB and neuroinflammatory markers including CD68. Additional biomarker data, including digital eye-tracking and cerebrospinal fluid results, are expected in October 2024 at the MDS meeting. Trial initiation is targeted for 2025 after regulatory alignment across the U.S., Europe, and Japan, with discussions expected to conclude in fall 2024. The U.S. phase I-B study remains under a "please don't start" FDA hold pending chronic toxicology data; cyno and rat data were completed and submitted by mid-summer 2024.
For spinal bulbar muscular atrophy (SBMA), or Kennedy's disease, preclinical mouse studies showed full recovery of endurance and strength with only 50% degradation of polyQ androgen receptor. Phase I is ongoing in healthy volunteers with patient enrollment planned later in the study. First-half 2025 data covering safety, tolerability, AR degradation and exploratory biomarkers are expected, with biomarker validation and trial design alignment targeted by end of 2025. The company is pursuing an accelerated approval path.
ARV-6723, an HPK1 degrader representing Arvinas's first immuno-oncology program, began clinical testing in the current quarter with data expected by the end of 2025 or later. On its G12D degrader program, Arvinas said it will advance only if a suitable partner is found.
Teel noted that BCL6 was one of the company's first programs aimed squarely at an undruggable target, following earlier work on androgen receptor and estrogen receptor.
