Arvinas’s Q2 2026 Earnings Call: ARV102 Trial Timeline Shifts and ARV393 Design/Data Contradictions

Date of Call: Aug 4, 2026

Financials Results

• Revenue: $249.7M, of which $62.5M from Rigel license agreement and $50M milestone from Pfizer

Guidance:

• Cash runway extended into second half of 2028.
• ARV393 initial phase one data expected by end of 2026; more mature monotherapy data planned for 2027.
• ARV027 multiple dose phase one trial in healthy volunteers ongoing; proof-of-mechanism data expected in first half of 2027.
• ARV102 regulatory interactions ongoing; aim to start registrational study in PSP in 2027.
• ARV6723 Phase I study initiation imminent; focus on immuno-oncology.

Business Commentary:

ARV393 (BCL6 degrader) Development:

• ARV393 has reached the phase one clinical trial, with enrollment challenges initially due to starting doses well below the predicted efficacious range.
• Enrollment has accelerated as doses approached the expected efficacious range, with early responses noted in T-cell lymphomas.
• The initial clinical validation supports continued dose escalation, with plans to share initial phase one data by the end of 2026.

ARV027 (PolyQAR degrader) for SBMA:

• The phase one trial in healthy volunteers has completed single ascending dose cohorts and initiated multiple dose cohorts.
• ARV027 aims to achieve greater than 50% poly-QAR degradation in skeletal muscle, a level believed to provide functional benefit.
• Preclinical data in an aggressive mouse model showed AR degradation far exceeding levels required for functional improvement.

ARV102 (LRRK2 degrader) Regulatory Path:

• Regulatory interactions are ongoing with the FDA and other global health authorities to initiate clinical trials in patients with PSP.
• The FDA requested additional information and final chronic tox data, which have now been completed.
• Plans are in place to initiate trials in the first half of 2027, with biomarker data to be shared at upcoming conferences.

Financial Position and Strategic Decisions:

• Arvinas reported $567.9 million in cash equivalents and marketable securities at the end of Q2 2026.
• The company received $62.5 million in license revenue from Rigel Pharmaceuticals and a $50 million milestone from Pfizer.
• Strategic decisions were made to out-license assets and focus on high-potential programs in oncology and neurology, aligning with a disciplined capital allocation strategy.

HPK1 (ARV6723) and Pan-KRAS (ARV1102) Programs:

• ARV6723, an oral HPK1 degrader, showed robust anti-tumor activity in preclinical models, including enhanced interferon signaling and tumor microenvironment remodeling.
• ARV1102, an oral pan-KRAS degrader, demonstrated potent activity across a broad range of KRAS mutations and showed superior anti-tumor activity in combination with immune checkpoint blockade.
• Both programs are advancing with plans for clinical translation, highlighting the potential of protein degradation in oncology.

Sentiment Analysis:

Overall Tone: Positive

• Management expressed confidence in pipeline progress, stating 'We are confident about... With that, I'll spend a few moments diving into our three assets with significant clinical data catalysts in the next 12 months.' They highlighted 'significant progress over the past several months' and a 'healthy balance sheet to reach critical milestones.'

Q&A:

• Question from Nick LaRusso (TD Cowen): On ARV393, can you discuss development plans, potentially a pivotal trial in an earlier line setting with bispecifics?
  Response: Yes, a BCL6 degrader could slot into various NHL treatment lines; options include later-line monotherapy or combination with bispecifics like Glofi, pending phase one dose escalation and efficacy signals.

• Question from Jacob (Wells Fargo), on behalf of Derek Archilla: What is the path forward for ARV102 in PSP and PD, given recent regulatory interactions?
  Response: Regulatory discussions with FDA, EMA, and JMA are ongoing; aim to start registrational study in PSP in 2027, with PD to follow.

• Question from Lai Watzak (Cantor Fitzgerald): What would be a good outcome from ARV393 data later this year, and where are you with dose levels and combinability?
  Response: Data at end of 2026 will focus on monotherapy at sub-therapeutic doses; enrollment has accelerated as doses approach predicted efficacious ranges, with combo data not anticipated then.

• Question from Edward Tenhoff (Piper Sandler): Where are you in multiple ascending dosing for ARV027, and what clinical endpoints are expected?
  Response: Multiple dose portion of phase one in healthy volunteers has begun; goal is to demonstrate 50% AR degradation in muscle and functional improvement in SBMA patients, with data expected in first half of 2027.

• Question from Jonathan Miller (Evercore): Will ARV027 degradation in healthy volunteers translate to patients, and what endpoints should we watch for ARV6723?
  Response: Degradation of wild-type AR in healthy volunteers is expected to translate to SBMA patients; for ARV6723, focus on monotherapy and combination with PD-1 in oncology trials to show differentiated immune remodeling.

• Question from Jagal (Citigroup): How do you square slow ARV393 enrollment at sub-therapeutic doses with effective responses seen, and thoughts on LRRK2 inhibitor trials?
  Response: Enrollment slowed initially due to low starting dose and competition with other therapies, but picked up as doses increased; LRRK2 inhibitors may not address all disease drivers, which is why a degrader approach is pursued.

• Question from EDSA (Barclays): What tumor types and combination partners are likely for ARV6723, and can you clarify licensing accounting changes?
  Response: ARV6723 will enroll patients in tumor types responsive to immunotherapy, with PD-1 as a potential combination; accounting changes involve removing deferred revenue from original Pfizer collaboration, with future royalties recognized traditionally.

• Question from Paul Choi (Goldman Sachs): What is the cadence for ARV102 updates in 2027, and how will ARV393 data influence clinical development?
  Response: ARV102 trial starts will dictate cadence; ARV393 development will watch bispecific landscape to decide on monotherapy or combination paths post-phase one.

• Question from Blake (BTIG): Will ARV102 target a specific PSP subtype or be an all-comers trial?
  Response: Trial may focus on Richardson syndrome, the largest subtype, but can expand to all PSP patients.

Contradiction Point 1

ARV102 (LRRK2 inhibitor) U.S. Trial Status and Timeline

Contradiction on whether the U.S. trial is on hold and the expected timeline for its start.

Jacob (on for Derek Archilla, Wells Fargo) - Jacob (on for Derek Archilla, Wells Fargo)

2026Q2: The U.S. Phase 1B trial is on clinical hold pending additional information and final chronic tox data, now expected to start in the first half of 2027. - Randy Thiel(CFO)

What is the development timeline and path forward for ARV102 in PSP and PD following recent regulatory interactions? - Derek Archila (Wells Fargo)

2026Q1: Yes, U.S. trial is on hold; no patients dosed. ... U.S. trial start anticipated by end of 2026. - Randy Teel(CFO)

Contradiction Point 2

ARV393 (BCL6 degrader) Trial Design and Differentiation

Contradiction on the trial design focus and the stated differentiation of the compound.

Nick LaRusso (TD Cowen) - Nick LaRusso (TD Cowen)

2026Q2: The next steps are to complete monotherapy dose escalation, demonstrate efficacy and combinability, and then move to discuss specific trial designs... to open up access to earlier lines (e.g., 3rd/2nd-line LBCL, T-cell diseases like AITL). - Randy Thiel(CFO)

Are there plans for a pivotal trial of ARV393 in an earlier line setting with bispecifics? - Michael Schmidt (Guggenheim)

2026Q1: ARV-393 is in phase I dose escalation. Differentiated by including AITL (angioimmunoblastic T-cell lymphoma), a rare, aggressive lymphoma with high unmet need. - Randy Teel(CFO)

Contradiction Point 3

ARV102 (LRRK2 degrader) - Timeline for Regulatory Pathway and Trial Initiation in PSP

Contradiction on whether an incremental PSP update is planned before Phase Ib trial starts.

Jacob (on for Derek Archilla, Wells Fargo) - Jacob (on for Derek Archilla, Wells Fargo)

2026Q2: The U.S. Phase 1B trial is on clinical hold... now expected to start in the first half of 2027. - Randy Thiel(CFO)

What is the updated timeline and development plan for ARV102 in PSP and PD following recent regulatory discussions? - Edward Tenthoff (Piper Sandler)

20260224-2025 Q4: No incremental PSP update is planned before the Phase Ib trial starts, as the timeline anticipates moving to a registrational trial by year-end. - Noah Berkowitz(CFO)

Contradiction Point 4

ARV393 (BCL6 degrader) - Focus and Disclosure of Phase 1 Data

Contradiction on the primary focus and planned disclosure of initial Phase 1 data.

Lai Watzak (Cantor Fitzgerald) - Lai Watzak (Cantor Fitzgerald)

2026Q2: The Phase 1 data at end-of-year 2026 will focus on monotherapy at doses below the predicted efficacious range... Combo data is not expected in the initial disclosure. - Randy Thiel(CFO)

What are the key milestones expected for ARV393's Phase 1 data later this year and the current progress on GLOPHI combo dose levels and early combinability trends? - Unknown Analyst (Cantor, on for Li Watsek)

20260224-2025 Q4: Confidence comes from seeing complete metabolic responses in lymphoma patients at doses below predicted efficacious exposures. The second-half data will focus on demonstrating the drug's efficacy and mechanism. - Noah Berkowitz(CFO)

Contradiction Point 5

ARV102 (LRRK2 degrader) - Regulatory Strategy and Trial Design Focus

Contradiction on the primary focus for the initial PSP trial (specific subtype vs. broader patient population).

Blake (on for Brigitte, U.S. Bancorp/ BTIG) - Blake (on for Brigitte, U.S. Bancorp/ BTIG)

2026Q2: The initial trial can focus on the Richardson syndrome subtype, which is the largest and most uniform in progression. However, the company is not restricted from expanding to all PSP patients later if needed. - Randy Thiel(CFO) & Angela Kikasi(CFO)

Does the ARV102 trial for PSP focus specifically on Richardson syndrome or include all PSP subtypes? - Sudan Loganathan (Stephens Inc.)

20260224-2025 Q4: For **PSP**, the Phase Ib will focus on the more aggressive PSPRS subtype using the PSP rating scale. - Noah Berkowitz(CFO)