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The call presented several major positive developments — notably the landmark FDA approval of VEPPANU (first heterobifunctional PROTAC approval), a global out-license to Rigel, robust early clinical and compelling preclinical data across multiple programs (ARV-102, ARV-806, ARV-393, ARV-6723, pan-KRAS), a healthy cash runway into H2 2028, and significant non-GAAP expense reductions improving financial flexibility. Counterbalancing these positives were a steep year-over-year revenue decline (driven by collaborative accounting changes), a quarter-over-quarter cash decline, an FDA-requested hold on the U.S. ARV-102 Phase 1b pending chronic NHP tox data (delaying U.S. patient dosing), and competitive/safety uncertainties in the KRAS landscape. Overall, the highlights — including the validation of the platform, key partnerships, and multiple programs advancing — materially outweigh the lowlights, supporting a positive outlook for the company.
Arvinas reiterated clear near‑term operational and financial guidance: it ended Q1 with $614.9M in cash, cash equivalents and marketable securities (down from $685.4M at year‑end 2025) and expects that cash to fund operations into the second half of 2028 while supporting four ongoing Phase 1 programs; Q1 revenue was $15.6M (vs. $188.8M year‑ago) as vepdegestrant revenue declined, G&A was $19.1M (vs. $26.6M), R&D was $60.3M (vs. $90.8M), non‑GAAP R&D fell ~$25M (‑32%), non‑GAAP G&A fell $10.1M (‑44%) and total non‑GAAP expenses were $67.3M (down $35.1M), reflecting cost reductions that largely finish mid‑2026; program milestones include ARV‑102 U.S. Phase 1b expected to start by end‑2026 pending mid‑2026 chronic NHP tox data (no change to planned global Phase 2 start), ARV‑806 and ARV‑393 clinical updates later in 2026, ARV‑6723 entering the clinic later this year, and anticipated cash inflows from a VEPPANU approval milestone plus upfront/near‑term Rigel milestones.
FDA approved VEPPANU for ESR1-mutant, ER+/HER2- advanced breast cancer — the first-ever heterobifunctional PROTAC degrader approval. Arvinas and Pfizer entered a global licensing agreement with Rigel for commercialization, development and manufacturing; Arvinas/Pfizer to split economics 50/50 for the out-license. Approval validates platform and de-risks modality.
Out-license to Rigel includes upfront and near-term milestones and an approval milestone expected later in the year that will provide cash inflows; Arvinas expects milestone/royalty economics to be shared with Pfizer (50/50) for U.S. approval-related payments.
Cash, cash equivalents and marketable securities were $614.9 million at 3/31/2026 (down from $685.4M at end of 2025). Company reiterates cash runway into the second half of 2028 to fund operations and key data milestones.
Non-GAAP R&D decreased by $25.0 million (a 32% reduction) and non-GAAP G&A decreased by $10.1 million (a 44% reduction) versus prior year. Total non-GAAP expenses were $67.3 million, down $35.1 million vs prior year, reflecting completed cost reduction programs and a new 2026 cost structure.
Phase 1 data showed approximately ≥50% reductions in CSF LRRK2 by day 14 (sustained through day 28) in Parkinson's disease patients, with dose-dependent reductions in downstream biomarkers (CD68, GPNMB). ARV-102 was generally well tolerated with no serious adverse events through 28 days.
Preclinical data show ~25–40x greater potency versus clinical-stage KRAS G12D inhibitors/degraders and durable degradation (>90% for 7 days after single dose). Phase 1 dose-escalation enrollment completed well ahead of schedule; initial clinical data expected later this year.
Ongoing Phase 1 monotherapy dose escalation in relapsed/refractory B- and T-cell lymphomas with early responses observed at exposures below predicted efficacious levels and robust BCL6 degradation. Combination trial with glofitamab in diffuse large B-cell lymphoma has been initiated.
Four Phase 1 clinical programs ongoing (plus additional programs planned), over 2,000 patients/volunteers dosed historically, and promising discovery programs (ARV-6723 HPK1 IO and oral pan-KRAS) progressing toward clinical entry later this year — demonstrating platform breadth.
Good day, and thank you for standing by. Welcome to the Arvinas First Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jeff Boyle, Head of Investor Relations. Please go ahead.
Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our first quarter 2026 financial results, which is available in the Investor and Media section of our website at arvinas.com. Joining us on the call today, we have Randy Teel, our President and CEO; Noah Berkowitz, our Chief Medical Officer; Angela Cacase, our Chief Scientific Officer; and Andrew Saik, our Chief Financial Officer. Before we begin, I'll remind you that today's discussion contains forward-looking statements that involve risks, uncertainties and assumptions. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which I urge you to read. Our actual results may differ materially from what is discussed on today's call. A replay of the call as well as today's press release and an updated corporate deck will be available on the Investor and Media section of our website. And now I'll turn the call over to Randy Teel.
Randy?
Thanks, Jeff, and thank you all for joining us today. Since stepping into the role as CEO earlier this year, my appreciation for the strength of the Arvinas platform, the talent and execution capability of our team, and our deep and differentiated ...