ARVINAS, INC.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-04.
0001628280-26-052554
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-03.
0001628280-26-069464
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 261 previous paragraphs and 266 current paragraphs.
172 unchanged; 67 reworded; 22 added; 18 removed; 4 previous and 5 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
** Pending clinical trial application submission and regulatory approval.
Current report
In addition, the Phase 1 clinical trial design also includes patients with SBMA in the later multiple dose cohorts. We expect to initiate dosing in a cohort that includes patients with SBMA in the first half of 2027. We believe that the forthcoming multiple ascending dose data in healthy volunteers and data in patients with SBMA will help determine whether ARV-027 produces the biological effects that would support advancement of ARV-027 into a registrational trial. These results together with chronic toxicology data and regulatory interactions will guide dose selection and our ARV-027 trial design for patients with SBMA.
Current report
ARV-6723 is an oral investigational PROTAC designed to degrade HPK1 in solid malignancies. ARV-6723 is our first clinical candidate in immuno-oncology and the first HPK1 PROTAC degrader to enter the clinic in the United States.
Current report
We plan to present preclinical data where we observed ARV-6723’s superior activity and anti-tumor responses compared to ICIs in checkpoint-resistant models at the Society for Immunotherapy of Cancer Annual Meeting in November 2026.
Current report
In the third quarter of 2026 we announced that we had initiated dosing in the Phase 1/2 clinical trial of ARV-6723 in patients with advanced solid tumors. The ARV-6723 Phase 1/2 clinical trial is a global, multicenter trial designed to assess the safety, tolerability, PK, and preliminary antitumor activity of orally administered ARV-6723 as a monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. The first-in-human trial will initially evaluate the safety of ARV-6723 as a monotherapy treatment and subsequently in combination with an anti-PD-1 therapy, while also evaluating whether deep and sustained HPK1 degradation translates into meaningful antitumor effects in patients. The initial monotherapy cohort of this trial is enrolling patients who have received a prior ICI and have no suitable standard treatment options. We anticipate initiating the dosing of patients in the combination cohort of ARV-6723 with pembrolizumab in mid-2027. We plan to present initial monotherapy data from the Phase 1 clinical trial in the second half of 2027.
Current report
In the fourth quarter of 2026, we presented novel data from a Phase 1 clinical trial of ARV-102 in patients with PD at the 2026 International Congress of Parkinson’s Disease and Movement Disorders® in Seoul, Korea. We believe these data support further clinical evaluation of ARV-102. The trial evaluated oral doses of ARV-102 ranging from 20 mg to 80 mg, as well as placebo, for 28 days, in a total of 24 patients with Parkinson’s disease. Notable findings included:
Current report
•Dose-dependent increases in amplitude of saccadic hypometria observed after 28 days of ARV-102 treatment compared with placebo, reflecting less severe hypometria;
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•Decreases in biomarkers associated with endolysosomal function and neuroinflammation;
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•Increases in biomarkers of synaptic integrity and axonal guidance; and
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•Associations between reductions in CSF LRRK2 protein levels and improvements in both oculomotor function and changes in pathway biomarkers of endolysosomal, neuroinflammatory, and synaptic function.
Current report
During the second quarter of 2026, we engaged with European and Japanese health authorities on our ARV-102 program in patients with PSP. Our discussions with Japan's Pharmaceutical and Medical Device Agency are ongoing as part of our global clinical strategy for patients with PSP. We plan to submit a CTA in the European Union, or EU, in the fourth quarter of 2026, and in the United Kingdom, or UK, in the first quarter of 2027, and we intend to initiate the Phase 1b clinical trial in patients with PSP in the EU and the UK, pending CTA submission and regulatory authorization, in 2027. Our objective is to include U.S. sites in future trials, after completing the anticipated Phase 1b clinical trial.
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Other Programs
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Approved and Outlicensed Product: VEPPANU
Current report
Revenue decreased by $41.4 million to $0.5 million for the three months ended September 30, 2026, from $41.9 million for the three months ended September 30, 2025. The decrease was primarily the result of (i) $20.6 million of revenue recognized in the prior-year period under the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, which did not recur following the recognition of all remaining deferred revenue in the second quarter of 2026 upon entry into the Rigel License Agreement, (ii) $20.0 million recognized in the prior-year period under the Novartis License Agreement, reflecting the achievement of a development milestone, and (iii) $1.3 million recognized in the prior-year period under the Pfizer Research Collaboration Agreement, which did not recur as the research program term concluded in the second quarter of 2026 and all remaining deferred revenue was recognized. Revenue for the current-year period consisted of $0.5 million of sales-based royalties recognized under the Rigel License Agreement.
Current report
Cost of license revenue totaled $0.1 million for the three months ended September 30, 2026, compared with zero for the three months ended September 30, 2025. The expense arose under the Amended Yale License Agreement, in connection with royalties under the Rigel License Agreement.
Current report
Non-GAAP research and development expenses decreased by $12.6 million to $44.3 million for the three months ended September 30, 2026, from $56.9 million for the three months ended September 30, 2025, excluding zero and $0.4 million of restructuring expense for the three months ended September 30, 2026 and 2025, respectively, and $2.6 million and $7.4 million of non-cash stock-based compensation expense for the three months ended September 30, 2026 and 2025, respectively.
Current report
Non-GAAP research and development expenses decreased by $45.8 million to $149.9 million for the nine months ended September 30, 2026, from $195.7 million for the nine months ended September 30, 2025, excluding $0.6 million and $1.0 million of restructuring expense for the nine months ended September 30, 2026 and 2025, respectively, and $9.3 million and $27.4 million of non-cash stock-based compensation expense for the nine months ended September 30, 2026 and 2025, respectively.
Current report
General and administrative expenses decreased by $8.4 million to $12.6 million for the three months ended September 30, 2026, from $21.0 million for the three months ended September 30, 2025. The decrease primarily reflected decreases of (i) $4.2 million in personnel and infrastructure related costs, (ii) $1.8 million in costs related to developing our commercial operations, and (iii) $1.5 million in professional fees.
Current report
Non-GAAP general and administrative expenses decreased by $5.4 million to $9.2 million for the three months ended September 30, 2026, from $14.6 million for the three months ended September 30, 2025, excluding zero and $0.6 million of restructuring related reversal of previously recognized expense for the three months ended September 30, 2026 and 2025, respectively, and $3.4 million and $7.0 million of non-cash stock-based compensation expense for the three months ended September 30, 2026 and 2025, respectively.
Current report
Non-GAAP general and administrative expenses decreased by $15.2 million to $40.7 million for the nine months ended September 30, 2026, from $55.9 million for the nine months ended September 30, 2025, excluding (i) $2.1 million of restructuring expense in 2026 and $0.3 million of restructuring-related reversal of previously recognized expense in 2025, and (ii) $12.9 million and $17.3 million of non-cash stock-based compensation expense for the nine months ended September 30, 2026 and 2025, respectively.
Current report
Net cash provided by financing activities for the nine months ended September 30, 2026 increased by $18.1 million, compared with the nine months ended September 30, 2025, primarily the result of repurchases of common shares of $17.8 million (including commissions and excise tax) in the prior year under our share repurchase plan.
Current report
•progress our preclinical programs;
Removed paragraphs (18)
Previous report
**Upon health authority clearance to proceed with clinical trials.
Previous report
ARV-806 is an investigational novel PROTAC designed to selectively target and degrade mutant KRAS G12D in solid tumors. KRAS is one of the most frequently mutated human oncogenes and G12D is the most common mutation of the KRAS protein. In normal cells, the KRAS protein regulates cell growth and functions as a molecular switch, cycling between a baseline “OFF” state and only turning “ON” when conditions are appropriate for growth. Mutations, including G12D, lock KRAS in the “ON” form, leading to uncontrolled cell growth and cancer. ARV-806 is designed to degrade both the ON and OFF forms of KRAS G12D and by removing this oncogenic protein, has the potential to shut down the constitutive growth signal and lead to death of the cancer cells. We believe ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer, or NSCLC, with KRAS G12D mutation.
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In the preclinical setting, ARV-806 demonstrated high potency and selectivity, with robust antitumor activity through dose-responsive degradation of KRAS G12D in KRAS G12D mutated cancer models, including pancreatic and colorectal models. ARV-806 formed a ternary complex with both the active "ON" and inactive "OFF" forms of KRAS G12D, achieving potent and durable elimination rather than inhibition of the target. As a result, in preclinical studies, ARV-806 achieved in vitro potency more than 25 times greater than clinical stage KRAS G12D "ON" and "OFF" inhibitors and more than 40 times greater than the leading KRAS G12D clinical-stage degrader.
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Approved Product: VEPPANU
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Preclinical and Other Programs
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We have active preclinical programs in neurology and oncology. In 2025 we announced two new product candidate nominees, ARV-027 and ARV-6723. As described above, we initiated a Phase 1 clinical trial for ARV-027 in the first quarter of 2026.
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We plan to initiate a Phase 1 clinical trial of ARV-6723 in patients with advanced solid tumors in the third quarter of 2026. Upon initiation of the clinical trial, ARV-6723 will be our first clinical candidate in immuno-oncology. The trial design includes a plan for dose escalation and an expansion combination cohort with
Previous report
pembrolizumab once sufficient monotherapy data are available.
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Pan-KRAS Program
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Our preclinical oral pan-KRAS program targets multiple variants of KRAS that drive solid tumors such as PDAC, colorectal cancer, NSCLC, and esophageal cancer, while sparing other RAS isoforms. We believe selectively targeting KRAS for removal may have benefits to tolerability compared with a pan-RAS approach. The poster presented at the 2025 Triple Meeting in the fourth quarter of 2025 showed that orally bioavailable pan-KRAS degraders have been identified that potently degrade multiple variants of KRAS and spare other RAS isoforms. A tool pan-KRAS PROTAC demonstrated robust single-agent activity and superior combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor (seven complete responses compared with two complete responses).
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In the first quarter of 2026, at the AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics, we presented preclinical data that demonstrated: robust efficacy in CDX models of pancreatic, colorectal, and lung cancer, greater tumor growth inhibition than a pan-RAS (ON) inhibitor in a KRAS G13D model, and enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor in a KRAS G12D syngeneic model.
Previous report
Revenue for the three months ended June 30, 2026 totaled $249.7 million, compared to $22.4 million for the three months ended June 30, 2025. The increase of $227.3 million was primarily due to $112.6 million of revenue from the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, driven by the recognition of the remaining deferred revenueof $126.4 million upon entry into the Rigel License Agreement as we concluded our remaining future performance obligations have been satisfied as a result of the terms of the Rigel License Agreement, partially offset by a decrease in revenue of $13.8 million for the period prior to the Rigel License Agreement. In addition, we recognized $62.5 million of revenue from the Rigel License Agreement, $50.0 million of revenue from adevelopment milestone payment in connection with the FDA’s approval of VEPPANU, and $2.2 million ofrevenue from the Pfizer Research Collaboration Agreement driven by the conclusion of the research program term and recognition of the remaining deferred revenue under the agreement.
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Non-GAAP research and development expenses for the three months ended June 30, 2026 totaled $51.4 million, compared to $59.5 million for the three months ended June 30, 2025, excluding $0.3 million and $0.6 million of restructuring expense for the three months ended June 30, 2026 and 2025, respectively, and $0.9 million and $8.5 million of non-cash stock-based compensation expense for the three months ended June 30, 2026 and 2025, respectively.
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Non-GAAP research and development expenses for the six months ended June 30, 2026 totaled $105.7 million, compared to $138.8 million for the six months ended June 30, 2025, excluding $0.6 million of restructuring expense for each of the six months ended June 30, 2026 and 2025, and $6.7 million and $20.0 million of non-cash stock-based compensation expense for the six months ended June 30, 2026 and 2025, respectively.
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Non-GAAP general and administrative expenses for the three months ended June 30, 2026 totaled $18.4 million, compared to $18.1 million for the three months ended June 30, 2025, excluding $1.3 million and $0.4 million of restructuring expense for the three months ended June 30, 2026 and 2025, respectively, and $4.3 million and $6.8 million of non-cash stock-based compensation expense for the three months ended June 30, 2026 and 2025, respectively.
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Non-GAAP general and administrative expenses for the six months ended June 30, 2026 totaled $31.3 million, compared to $41.3 million for the six months ended June 30, 2025, excluding $2.1 million and $0.4 million of restructuring expense for the six months ended June 30, 2026 and 2025, respectively, and $9.6 million and $10.2 million of non-cash stock-based compensation expense for the six months ended June 30, 2026 and 2025, respectively.
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Net cash provided by financing activities for the six months ended June 30, 2026 decreased by $0.1 million, compared with the six months ended June 30, 2025.
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•progress our preclinical programs, including ARV-6723 and our pan-KRAS degrader program;
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Previous wording
We are a biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, protein degradation platform, we are pioneering the development of a new class of therapeutics designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. We believe that our targeted protein degradation approach is a novel therapeutic modality that may provide distinct advantages over existing therapies and address a broad range of targets, including historically undruggable proteins, in areas of significant unmet need.
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We are a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, protein degradation platform, we are pioneering the development of a new class of therapeutics designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. We believe that our targeted protein degradation approach is a novel therapeutic modality that may provide distinct advantages over existing therapies and address a broad range of targets, including historically undruggable proteins, in areas of significant unmet need.
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In the past five years, seven of the programs developed using our PROTAC protein degradation platform have progressed to clinical trials in oncology and neurology indications after demonstrating potent and selective protein degradation in our preclinical studies. We believe favorable clinical trial results in our ongoing oncology and neurology programs would further validate our platform as a new therapeutic modality for the potential treatment of diseases caused by dysregulated intracellular proteins.
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In the past five years, eight of the programs developed using our PROTAC protein degradation platform have entered clinical trials in oncology and neurology indications after demonstrating potent and selective protein degradation in our preclinical studies. We believe favorable clinical trial results in our ongoing oncology and neurology programs would further validate our platform as a new therapeutic modality for the potential treatment of diseases caused by dysregulated intracellular proteins.
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Also in the second quarter of 2026, we and Pfizer Inc., or Pfizer, entered into a license agreement with Rigel Pharmaceuticals, Inc., or Rigel, for the exclusive global development, manufacturing, and commercialization rights for VEPPANU, or the Rigel License Agreement. Under the terms of the Rigel License Agreement, Rigel is responsible for the launch and commercialization of VEPPANU in the U.S. and owns global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S. We and Pfizer are entitled to a percentage of sublicensing revenue generated outside the U.S. Rigel has agreed to reimburse us and Pfizer up to $40.0 million of the costs of ongoing development activities that were in progress as of the effective date of the Rigel License Agreement. While Pfizer is responsible for these ongoing development activities, we and Pfizer will share equally in this reimbursement and therefore we will reimburse Pfizer for 50% of the costs of such activities.
Current wording
Also in the second quarter of 2026, we and Pfizer Inc., or Pfizer, entered into a license agreement with Rigel Pharmaceuticals, Inc., or Rigel, for the exclusive global development, manufacturing, and commercialization rights for VEPPANU, or the Rigel License Agreement. Under the terms of the Rigel License Agreement, Rigel is and will continue to be responsible for the commercialization of VEPPANU in the U.S. and owns global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S. We and Pfizer are entitled to a percentage of sublicensing revenue generated outside the U.S. Rigel has agreed to reimburse us and Pfizer up to $40.0 million of the costs of ongoing development activities that were in progress as of the effective date of the Rigel License Agreement. While Pfizer is responsible for these ongoing development activities, we and Pfizer will share equally in this reimbursement and therefore we will reimburse Pfizer for 50% of the costs of such activities.
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Pursuant to the terms of the Rigel License Agreement, Rigel paid to us and Pfizer a one-time, upfront payment in the aggregate amount of $70.0 million. In addition, we and Pfizer will receive an additional upfront payment in the amount of $15.0 million upon successful completion of select development and manufacturing transition activities. We and Pfizer are also eligible to receive up to an additional $320.0 million as contingent payments based on future development, regulatory and commercial milestones being met, as well as tiered royalties in the mid-teens to mid-20s based upon worldwide net sales of VEPPANU, subject to reduction under certain circumstances as provided in the Rigel License Agreement. All payments under the Rigel License Agreement will be shared equally between us and Pfizer. In connection with and to facilitate entry into the Rigel License Agreement, in the second quarter of 2026, we and Pfizer also entered into a letter agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement, or the Pfizer Letter Agreement, which was accounted for as a contract modification. Pursuant to the terms of the Pfizer Letter Agreement, until any termination of the Rigel License Agreement, the milestones and royalty payments under the Rigel License Agreement replace any unearned future amounts that may be owed by Pfizer to us under the Original Vepdegestrant (ARV-471) Collaboration Agreement.
Current wording
Pursuant to the terms of the Rigel License Agreement, Rigel paid to us and Pfizer a one-time, upfront payment in the aggregate amount of $70.0 million. In addition, we and Pfizer will receive an additional upfront payment in the amount of $15.0 million upon successful completion of select development and manufacturing transition activities. We and Pfizer are also eligible toreceive up to an additional $320.0 million as contingent payments based on future development, regulatory and commercial milestones being met, as well as tiered royalties in the mid-teens to mid-20s based upon worldwide net sales of VEPPANU, subject to reduction under certain circumstances as provided in the Rigel License Agreement. All payments under the Rigel License Agreement will be shared equally between us and Pfizer. In connection with and to facilitate entry into the Rigel License Agreement, in the second quarter of 2026, we and Pfizer also entered into a letter agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement, or the Pfizer Letter Agreement, which was accounted for as a contract modification. Pursuant to the terms of the Pfizer Letter Agreement, until any termination of the Rigel License Agreement, the milestones and royalty payments under the Rigel License Agreement replace any unearned future amounts that may be owed by Pfizer to us under the Original Vepdegestrant (ARV-471) Collaboration Agreement.
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Our pipeline, which includes an overview of our clinical and preclinical programs, as well as out-licensed programs, is summarized below.
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Our pipeline, which includes an overview of our clinical programs, as well as out-licensed programs, is summarized below.
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*The agents, other than VEPPANU which has been approved by the FDA, in the pipeline graphic above are currently under investigation; their safety and effectiveness for these investigational uses have not been established.
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These agents, other than VEPPANU which has been approved by the FDA, are currently under investigation and their safety and effectiveness for these investigational uses have not been established.
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•Defined terms used in pipeline graphic: AR, androgen receptor; BCL6, B-cell lymphoma 6; ER+, estrogen receptor positive; ESR1, estrogen receptor 1; DLBCL, diffuse large b-cell lymphoma; HER2-, human epidermal growth factor receptor 2-negative; HPK1, hematopoietic progenitor kinase 1; HV: healthy volunteers; I-O, immuno-oncology; KRAS, Kirsten rat sarcoma viral oncogene homolog; LRRK2, leucine-rich repeat kinase 2; mCRPC, metastatic castration resistant prostate cancer; mHSPC, metastatic hormone sensitive prostate cancer; NSCLC, non-small cell lung cancer; NDA, new drug application; NHL, non-Hodgkin lymphoma; polyQ, expanded polyglutamine; PSP, progressive supranuclear palsy; SBMA, spinal-bulbar muscular atrophy.
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•Defined terms used in pipeline graphic above: AR, androgen receptor; BCL6, B-cell lymphoma 6; DLBCL, diffuse large B-cell lymphoma; HPK1, hematopoietic progenitor kinase 1; HV, healthy volunteers; LRRK2, leucine-rich repeat kinase 2; PD, Parkinson's disease; polyQ, expanded polyglutamine; PSP, progressive supranuclear palsy; and SBMA, spinal-bulbar muscular atrophy.
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•Footnotes included in pipeline graphic: 1. Includes relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL) and relapsed/refractory mature B cell NHL; 2. Phase 1/2 combination trials with palbociclib, atirmociclib, abemaciclib, ribociclib, samuraciclib, everolimus.
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•Footnote included in pipeline graphic above: 1. Includes relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL) and relapsed/refractory mature B cell NHL.
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In addition to the programs above and any early-stage collaborations, including with Pfizer, we are conducting exploratory research and development work on multiple other undisclosed targets.
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In addition to the programs above and any early-stage collaborations, we are conducting exploratory research and development work on multiple other undisclosed targets.
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Clinical Stage Programs: ARV-393, ARV-102, ARV-027 and ARV-806
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Clinical Stage Programs: ARV-393, ARV-027, ARV-6723 and ARV-102
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We initiated the monotherapy cohort of our first-in-human Phase 1 clinical trial of ARV-393 in patients with relapsed or refractory NHL in the second quarter of 2024 and are currently recruiting patients for this clinical trial. This is an open-label, multicenter, Phase 1 dose escalation trial to evaluate the safety, tolerability PK, pharmacodynamics, and preliminary anti-tumor activity of ARV-393 as a single agent in adult patients with relapsed/refractory NHL. We announced in the first quarter of 2026, and have since reiterated that there have been multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas in the first-in-human Phase 1 clinical trial. We believe these early data support an emerging, and differentiated, therapeutic benefit of ARV-393. Dose escalation in the trial is ongoing and the safety profile of ARV-393 supports continuing dose escalation. We plan to share clinical data from the early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial of ARV-393 in patients with relapsed/refractory NHL at a medical congress in the second half of 2026. We expect that the majority of this data in 2026 will be from the early cohorts dosed below the expected efficacious range. These early monotherapy cohorts, when compared with the overall lymphoma population, include a higher-than-predicted proportion of patients with T-cell lymphomas, which we believe reflects the limited treatment options for these patients. However, as we’ve approached the predicted efficacious range, enrollment of patients, including those with B-cell lymphomas, has increased. We anticipate sharing additional monotherapy data in the ongoing Phase 1 dose escalation clinical trial in patients with B- and T-cell lymphomas in mid-2027.
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We initiated the monotherapy cohort of our first-in-human Phase 1 clinical trial of ARV-393 in patients with relapsed or refractory NHL in the second quarter of 2024 and enrollment in this clinical trial is ongoing. This is an open-label, multicenter, Phase 1 dose escalation trial to evaluate the safety, tolerability PK, pharmacodynamics, and preliminary anti-tumor activity of ARV-393 as a single agent in adult patients with relapsed/refractory NHL. We announced in the first quarter of 2026, and have since reiterated that there have been multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas in the first-in-human Phase 1 clinical trial. We believe these early data support an emerging, and differentiated, therapeutic benefit of ARV-393. Dose escalation in the Phase 1 clinical trial is ongoing and the safety profile of ARV-393 supports continuing dose escalation.
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In addition, in the second quarter of 2026, we announced the initiation of a combination cohort in the ongoing Phase 1 clinical trial to evaluate ARV-393 in combination with glofitamab as a chemotherapy-free combination approach in patients with DLBCL. Enrollment in this clinical trial is currently ongoing, and we plan to share data from this combination cohort of ARV-393 with glofitamab in patients with DLBCL in mid-2027.
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In addition, in the second quarter of 2026, we announced the initiation of a combination cohort in the ongoing Phase 1 clinical trial to evaluate ARV-393 in combination with glofitamab as a chemotherapy-free combination approach in patients with DLBCL. Enrollment in this clinical trial is currently ongoing, and we plan to share initial data from this combination cohort of ARV-393 with glofitamab in patients with DLBCL in mid-2027.
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We initiated the first-in-human Phase 1 clinical trial in ARV-027 in healthy volunteers in the first quarter of 2026. In the second quarter of 2026, we completed the single-ascending dose cohorts in the first-in-human Phase 1 clinical trial in healthy volunteers and, in the third quarter of 2026, we initiated enrollment in the multiple dose cohorts in the Phase 1 clinical trial in healthy volunteers. We plan to continue enrollment in the multiple dose cohort of the Phase 1 clinical trial of ARV-027 in healthy volunteers and share initial data evaluating AR-degradation in muscle in the first half of 2027. In addition, the Phase 1 clinical trial design also includes patients with SBMA in the later multiple dose cohorts.
Current wording
We initiated the first-in-human Phase 1 clinical trial in ARV-027 in healthy volunteers in the first quarter of 2026. In the second quarter of 2026, we completed the single-ascending dose cohorts in the first-in-human Phase 1 clinical trial in healthy volunteers. In the third quarter of 2026, we initiated enrollment in a multiple ascending dose cohort in the Phase 1 clinical trial in healthy volunteers. We plan to continue enrollment in the multiple ascending dose cohorts of the Phase 1 clinical trial of ARV-027 in healthy volunteers and share initial data evaluating AR-degradation in muscle in the first half of 2027.
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ARV-6723 is an oral investigational PROTAC designed to degrade HPK1 in solid malignancies. Preclinically, ARV-6723 has shown potent, selective HPK1 degradation and strong anti-tumor immune responses with superior tumor control in low- and high- immunogenic murine syngeneic tumor models. In solid tumor malignancies, such as NSCLC, melanoma, and renal cell carcinoma, or RCC, HPK1 acts as a negative regulator in T-cell receptor signaling, contributing to T-cell exhaustion and suppressing antitumor immunity. In addition, HPK1 has a regulatory role in other immune cell types that can be co-opted by tumors, thus enabling these cancers to resist immuno-oncology therapy. Degrading HPK1 and thus eliminating both its kinase and scaffolding functions has the potential to unleash an immune response with potent anti-tumor effects and minimum off-target toxicity.
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Preclinically, ARV-6723 has shown potent, selective HPK1 degradation and strong anti-tumor immune responses with superior tumor control in low- and high- immunogenic murine syngeneic tumor models. In solid tumor malignancies, such as NSCLC, melanoma, and renal cell carcinoma, or RCC, HPK1 acts as a negative regulator in T-cell receptor signaling, contributing to T-cell exhaustion and suppressing antitumor immunity. In addition, HPK1 has a regulatory role in other immune cell types that can be co-opted by tumors, thus enabling these cancers to resist immuno-oncology therapy. Degrading HPK1 and thus eliminating both its kinase and scaffolding functions has the potential to unleash an immune response with potent anti-tumor effects and minimum off-target toxicity.
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We presented preclinical data at the Society for Immunotherapy of Cancer annual meeting in the fourth quarter of 2025 that we believe supports the potential of ARV-6723 to provide sustained anti-tumor immune response as a single agent or in combination with standards of care with improved clinical benefits, including that: ARV-6723, as a single agent, demonstrates anti-tumor efficacy superior to anti-PD1 or a clinical HPK1 inhibitor and combines with anti-PD1 to further enhance response; and ARV-6723 single agent activity outperforms the HPK1 inhibitor and anti-PD-1 efficacy and reinstitutes the tumor microenvironment.
Current wording
We presented preclinical data at the Society for Immunotherapy of Cancer annual meeting in the fourth quarter of 2025 that we believe supports the potential of ARV-6723 to provide sustained anti-tumor immune response as a single agent or in combination with standards of care with improved clinical benefits, including that: ARV-6723, as a single agent, demonstrated anti-tumor efficacy superior to anti-PD1 or a clinical HPK1 inhibitor and combined with anti-PD1 to further enhance response; and ARV-6723 single agent activity outperformed the HPK1 inhibitor and anti-PD-1 efficacy and reinstitutes the tumor microenvironment.
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At the AACR Annual Meeting in the second quarter of 2026, we presented preclinical data that demonstrated greater antitumor activity than SOC ICIs or an investigational HPK1 inhibitor. These preclinical data presented showed that ARV-6723, unlike an inhibitor and the ICIs, reverses T-cell exhaustion, reverses the immunosuppressive microenvironment and boosts innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models. We believe these preclinical results support future investigation of ARV-6723 alone or in combination with other agents in patients with high- or low-immunogenic tumors.
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At the AACR Annual Meeting in the second quarter of 2026, we presented preclinical data that demonstrated greater antitumor activity than SOC ICIs or an investigational HPK1 inhibitor. These preclinical data presented showed that ARV-6723, unlike an inhibitor and the ICIs, reversed T-cell exhaustion, reversed the immunosuppressive microenvironment and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models. We believe these preclinical results support future investigation of ARV-6723 alone or in combination with other agents in patients with high- or low-immunogenic tumors.
Previous wording
Based on the data, we plan to continue investigation of ARV-102 in neurodegenerative diseases associated with LRRK2 and endolysosomal dysfunction. We plan to share additional biomarker data from the Phase 1 clinical trial in patients with PD at the International Congress on Parkinson’s Disease and Movement Disorders in the fourth quarter of 2026.
Current wording
Based on the data, we plan to continue investigation of ARV-102 in neurodegenerative diseases associated with LRRK2 and endolysosomal dysfunction.
Previous wording
We submitted an investigational new drug application, or IND, earlier this year for ARV-102 with the intention of initiating a Phase 1b clinical trial in patients with PSP in the U.S. during first half of 2026. Following the 30-day review period, prior to authorizing the initiation of the Phase 1b clinical trial in the U.S. in patients with PSP, the FDA requested additional information as well as final data from our chronic toxicology studies in non-human primates, which we recently completed. As a result of the FDA’s request, the planned Phase 1b clinical trial, in which we have not yet dosed any patients, is on clinical hold and will not begin until the FDA completes its review and authorizes initiation of the clinical trial. In addition, during the second quarter of 2026, we engaged with European and Japanese health authorities on our ARV-102 program in patients with PSP. Our discussions with global health authorities are ongoing. We plan to continue these discussions and, subject to regulatory clearance, we plan to initiate clinical trials in patients with PSP in 2027. We continue to evaluate development options for ARV-102 in PD.
Current wording
We submitted an investigational new drug application, or IND, earlier this year for ARV-102 with the intention of initiating a Phase 1b clinical trial in patients with PSP in the U.S. during the first half of 2026. Following the 30-day review period, prior to authorizing the initiation of the Phase 1b clinical trial in the U.S. in patients with PSP, the FDA requested additional information as well as final data from our chronic toxicology studies in non-human primates, which we completed. As a result of the FDA’s request, the planned Phase 1b clinical trial, in which we have not yet dosed any patients, is on clinical hold and will not begin until the FDA completes its review and authorizes initiation of the clinical trial. Our discussions with the FDA regarding this clinical hold are ongoing.
Previous wording
In the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. Under the terms of the Rigel License Agreement, Rigel will be responsible for the launch and commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S.
Current wording
In the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. Under the terms of the Rigel License Agreement, Rigel is and will continue to be responsible for the commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S.
Previous wording
•VERITAC, a Phase 2 dose expansion clinical trial of vepdegestrant as a monotherapy, targeting previously treated metastatic breast cancer;
Current wording
•VERITAC, a Phase 1/2 dose expansion clinical trial of vepdegestrant as a monotherapy, targeting previously treated metastatic breast cancer;
Previous wording
Based on the results from VERITAC-2, in the second quarter of 2025, we and Pfizer submitted an NDA to the FDA for vepdegestrant for the treatment of patients with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This represented the first NDA submitted for a PROTAC. In the third quarter of 2025, we announced that the FDA accepted the NDA for vepdegestrant and assigned a PDUFA action date of June 5, 2026. In the second quarter of 2026, we announced that the FDA has approved the Company’s new drug application for VEPPANU for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. In the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU, which isdiscussed in greater detail below and in Note 3, Research Collaboration and License Agreements.
Current wording
Based on the results from VERITAC-2, in the second quarter of 2025, we and Pfizer submitted an NDA to the FDA for vepdegestrant for the treatment of patients with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This represented the first NDA submitted for a PROTAC. In the third quarter of 2025, we announced that the FDA accepted the NDA for vepdegestrant and assigned a PDUFA action date of June 5, 2026.
Previous wording
for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*
Current wording
In the second quarter of 2026, we announced that the FDA has approved the Company’s new drug application for VEPPANU for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. On May 8, 2026, the National Comprehensive Cancer Network® (NCCN®) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor. *
Previous wording
We filed an IND with the FDA for ARV-806 in the first quarter of 2025 and received a safe-to-proceed letter from the FDA in the second quarter of 2025. We initiated enrollment in a Phase 1 clinical trial of ARV-806 in patients with advanced solid tumors harboring KRAS G12D mutations in the second quarter of 2025 and this trial is currently ongoing.
Current wording
ARV-806 is an investigational novel PROTAC designed to selectively target and degrade mutant KRAS G12D in solid tumors. We initiated enrollment in a Phase 1 clinical trial of ARV-806 in patients with advanced solid tumors harboring KRAS G12D mutations in the second quarter of 2025.
Previous wording
In the second quarter of 2026, we announced that we had completed dose escalation enrollment of the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations. We are planning to complete this Phase 1 monotherapy dose escalation clinical trial and share clinical data in the second half of 2026. In the second quarter of 2026 we also announced that we plan to seek an out-licensing agreement for any additional clinical trials of ARV-806, including dose expansion or combination clinical trials.
Current wording
In the second quarter of 2026, we announced that we had completed dose escalation enrollment of the Phase 1 clinical trial, and we plan to share clinical data from this Phase 1 monotherapy dose escalation clinical trial in the fourth quarter of 2026. In the second quarter of 2026 we also announced that we plan to seek an out- licensing agreement for any additional clinical trials of ARV-806, including dose expansion or combination clinical trials.
Previous wording
We commenced operations in 2013. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, undertaking preclinical studies and clinical trials, establishing arrangements with third parties for collaborations or licensing arrangements and for the manufacture of initial quantities of our product candidates and preparing for potential commercialization. To date, we have not generated any revenue from product sales and have financed our operations primarily through sales of assets and equity interests, proceeds from our collaborations and licensing arrangements, an asset sale, grant funding and debt financing. Since inception through June 30, 2026, we raised approximately $1.7 billion in gross proceeds from the sale of assets and equity interests and the exercise of stock options and had received an aggregate of $1.0 billion in payments primarily from collaboration partners and a licensing arrangement.
Current wording
We commenced operations in 2013. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, undertaking preclinical studies and clinical trials, establishing arrangements with third parties for collaborations or licensing arrangements and for the manufacture of initial quantities of our product candidates and preparing for potential commercialization. To date, we have not generated any revenue from product sales and have financed our operations primarily through sales of assets and equity interests, proceeds from our collaborations and licensing arrangements, an asset sale, grant funding and debt financing. During the three and nine months ended September 30, 2026, we recognized $0.5 million of sales-based royalties under the Rigel License Agreement.
Previous wording
We are a biotechnology company, with product candidates in clinical development and other drug discovery activities in the research and preclinical development stages. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates.
Current wording
We are a clinical-stage biotechnology company, with product candidates in clinical development and other drug discovery activities in the research and preclinical development stages. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates.
Previous wording
In the second quarter of 2026, we announced that the FDA has approved VEPPANU for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. Also in the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel. Our ability to generate revenue from the sale of VEPPANU will be entirely dependent on Rigel, and we may never generate product revenue from the Rigel License Agreement to realize any profits from the out-license of VEPPANU.
Current wording
In the second quarter of 2026, we announced that the FDA has approved VEPPANU for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. Also in the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel. Our receipt of royalties from Rigel's sale of VEPPANU, and the timing thereof, will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agreement. We have no control over the amount or timing of the receipt of any royalties and may never realize any profits from the out-license of VEPPANU. However, we did begin to earn sales-based royalties during the third quarter of 2026 of $0.5 million and anticipate royalties to continue in the fourth quarter of 2026.
Previous wording
As noted above, our ability to generate revenue from the sale of VEPPANU will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agreement, and we may never generate product revenue from the Rigel License Agreement to realize any profits from the out-license of VEPPANU.
Current wording
We do not expect to generate any revenue from product sales in the near future, if ever. As noted above, our receipt of royalties from Rigel's sale of VEPPANU, and the timing thereof, will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agreement. We have no control over the amount or timing of the receipt of any royalties and may never realize any profits from the out-license of
Previous wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of$567.9 million. We believe the existing cash, cash equivalents and marketable securities on hand will be sufficient to fund our operations into the second half of 2028, which will enable us to execute on multiple data readouts across our programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources” below.
Current wording
As of September 30, 2026, we had cash, cash equivalents, restricted cash and marketable securities of$558.9 million. We believe the existing cash, cash equivalents and marketable securities on hand will be sufficient to fund our operations into the second half of 2028, which will enable us to execute on multiple data readouts across our programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources” below.
Previous wording
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future, other than potentially pursuant to the Rigel License Agreement. Our revenues to date have been generated through research collaborations, licensing arrangements and an asset sale. Revenue is recognized ratably over our expected performance period under each agreement.
Current wording
Our revenues to date have been generated through research collaborations, licensing arrangements and an asset sale. Revenue is recognized ratably over our expected performance period under each agreement.
Previous wording
While we do have one approved product, VEPPANU, and we have entered into the Rigel License Agreement, our ability to generate revenue from the sale of VEPPANU will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agreement, and we may never generate product revenue from the Rigel License Agreement to realize any profits from the out-license of VEPPANU. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel.
Current wording
To date, we have not generated any revenue from product sales and we do not expect to generate any revenue from the sale of products in the near future. While we do have one approved product, VEPPANU, we have entered into the Rigel License Agreement granting to Rigel a license for the exclusive global development, manufacturing and commercialization rights for VEPPANU, under which we are entitled to receive tiered royalties in the mid-teens to mid-20s based upon worldwide net sales of VEPPANU. Our receipt of royalties from Rigel's sale of VEPPANU, and the timing thereof, will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agreement. We have no control over the amount or timing of the receipt of any royalties and may never realize any profits from the out-license of VEPPANU. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel. During the three and nine months ended September 30, 2026, we recognized $0.5 million of sales-based royalties under the Rigel License Agreement.
Previous wording
We expect that any revenue recognized in the near term will be derived primarily from our current collaboration agreements and licensing arrangements and any additional arrangements that we may enter into in the future. We received a $20.0 million development milestone during the year ended December 31, 2025 pursuant to the terms of the Novartis License Agreement and a $50.0 million development milestone during the three months ended June 30, 2026 pursuant to the Original Vepdegestrant (ARV-471) Collaboration Agreement in connection with the FDA’s approval of VEPPANU. To date, no other development, regulatory and commercial milestone payments or royalties have been received under any of our other collaboration agreements or licensing arrangements.
Current wording
We expect that any revenue recognized in the near term will be derived primarily from our current collaboration agreements and licensing arrangements and any additional arrangements that we may enter into in the future. We received a $20.0 million development milestone during the year ended December 31, 2025 pursuant to the terms of the Novartis License Agreement and a $50.0 million development milestone during the nine months ended September 30, 2026 pursuant to the Original Vepdegestrant (ARV-471) Collaboration Agreement in connection with the FDA’s approval of VEPPANU.
Previous wording
On May 11, 2026, we, including our direct subsidiaries, Arvinas Operations, Inc. and Arvinas Estrogen Receptor, Inc., together with Pfizer, entered into the Rigel License Agreement with Rigel. Pursuant to the Rigel License Agreement, we and Pfizer granted to Rigel a license for the exclusive global development, manufacturing and commercialization rights for VEPPANU, an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by a FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Current wording
On May 11, 2026, we, including our direct subsidiaries, Arvinas Operations, Inc. and Arvinas Estrogen Receptor, Inc., together with Pfizer, entered into the Rigel License Agreement with Rigel. Pursuant to the Rigel License Agreement, we and Pfizer granted to Rigel a license for the exclusive global development, manufacturing and commercialization rights for VEPPANU, an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), estrogen receptor degrader approved in the U.S. for use as a monotherapy in the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by a FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Previous wording
Under the terms of the Rigel License Agreement, Rigel will be responsible for the launch and commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S. We and Pfizer will be entitled to a percentage of sublicensing revenue generated outside the U.S. Rigel has agreed to reimburse us and Pfizer up to $40.0 million of the costs of ongoing development activities that were in progress as of the effective date of the Rigel License Agreement. While Pfizer is responsible for these ongoing development activities, we and
Current wording
Under the terms of the Rigel License Agreement, Rigel is and will continue to be responsible for the commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S. We and Pfizer will be entitled to a percentage of sublicensing revenue generated outside the U.S. Rigel has agreed to reimburse us and Pfizer up to $40.0 million of the costs of ongoing development activities that were in progress as of the effective date of the Rigel License Agreement. While Pfizer is responsible for these ongoing development activities, we and Pfizer will share equally in this reimbursement and therefore we will reimburse Pfizer for 50% of the costs of such activities.
Previous wording
In the second quarter of 2026, we announced that the FDA has granted approval for VEPPANU for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. Pursuant to the Original Vepdegestrant (ARV-471) Collaboration Agreement, we received $50.0 million as a development milestone payment in connection with the FDA’s approval of VEPPANU.
Current wording
In the second quarter of 2026, we announced that the FDA granted approval for VEPPANU for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine-based therapy. Pursuant to the Original Vepdegestrant (ARV-471) Collaboration Agreement, we received $50.0 million as a development milestone payment in connection with the FDA’s approval of VEPPANU.
Previous wording
In the year ended December 31, 2018, we received an upfront non-refundable payment and certain additional payments totaling $28.0 million in exchange for use of the technology license and to fund Pfizer-related research, as defined within the Pfizer Research Collaboration Agreement. As of June 30, 2026, the research program term under the Pfizer Research Collaboration Agreement has concluded and no targets currently remain. In accordance with the terms of the Pfizer Research Collaboration Agreement, we were eligible to receive up to an additional $3.8 million in non-refundable option payments if Pfizer exercised its option for the then-remaining target protein under the Pfizer Research Collaboration Agreement. Under the terms of the Pfizer Research Collaboration Agreement, we were also entitled to receive up to $225.0 million in development milestone payments and up to $550.0 million in sales-based milestone payments for all designated target proteins under the Pfizer Research Collaboration Agreement, as well as tiered royalties based on sales, which were subject to reductions. There were no sales-based milestone payments or royalties received through June 30, 2026.
Current wording
In accordance with the terms of the Pfizer Research Collaboration Agreement, we were eligible to receive up to an additional $3.8 million in non-refundable option payments if Pfizer exercised its option for the then-remaining target protein under the Pfizer Research Collaboration Agreement. Under the terms of the Pfizer Research Collaboration Agreement, we were also entitled to receive up to $225.0 million in development milestone payments and up to $550.0 million in sales-based milestone payments for all designated target proteins under the Pfizer Research Collaboration Agreement, as well as tiered royalties based on sales, which were subject to reductions.
Previous wording
Under the terms of and as consideration for entering into the Novartis Transaction, we received a one-time, upfront payment in the aggregate amount of $150.0 million from Novartis. Under the Novartis License Agreement, we are also eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory, and commercial milestones for luxdegalutamide (ARV-766) being met, as well as tiered royalties based upon worldwide net sales of luxdegalutamide (ARV-766), subject to reduction under certain circumstances as provided in the Novartis License Agreement. During the year ended December 31, 2025, we received $20.0 million upon the achievement ofa development milestone pursuant to the terms of the Novartis License Agreement. There were no development, regulatory or commercial milestone payments, or sales-based royalties received during the six months ended June 30, 2026.
Current wording
Under the terms of and as consideration for entering into the Novartis Transaction, we received a one-time, upfront payment in the aggregate amount of $150.0 million from Novartis. Under the Novartis License Agreement, we are also eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory, and commercial milestones for luxdegalutamide (ARV-766) being met, as well as tiered royalties based upon worldwide net sales of luxdegalutamide (ARV-766), subject to reduction under certain circumstances as provided in the Novartis License Agreement. During the year ended December 31, 2025, we received $20.0 million upon the achievement ofa development milestone pursuant to the terms of the Novartis License Agreement.
Previous wording
In September 2015, we entered into an Option and License Agreement with Genentech focused on PROTAC targeted protein degrader discovery and research for target proteins based on our proprietary platform technology, other than excluded target proteins as described below. This collaboration was expanded in November 2017 through an Amended and Restated Option, License and Collaboration Agreement, which we refer to as the Restated Genentech Agreement. Concurrently with entering into the Restated Genentech Agreement, Genentech exercised its exclusive option with respect to a PROTAC targeted protein degrader. We receive annual updates on research and development activities related to this option.
Current wording
In September 2015, we entered into an Option and License Agreement with Genentech focused on PROTAC targeted protein degrader discovery and research for target proteins based on our proprietary platform technology, other than excluded target proteins as described below. This collaboration was expanded in November 2017 through an Amended and Restated Option, License and Collaboration Agreement, which we refer to as the Restated Genentech Agreement. Concurrently with entering into the Restated Genentech Agreement, Genentech exercised its exclusive option with respect to a PROTAC targeted protein degrader. We received annual updates on research and development activities related to this option.
Previous wording
Under the Restated Genentech Agreement, Genentech had the right to designate up to ten targets for further discovery and research utilizing our PROTAC platform technology and also had the right to remove a target from the collaboration and substitute a different target that is not an excluded target at any time prior to us commencing research on such target or in certain circumstances following commencement of research by us. The research phase of the collaboration with Genentech ended, and Genentech was no longer able to nominate new targets into the collaboration. As of March 31, 2026, the only target that remained part of the collaboration was the PROTAC targeted protein degrader for which Genentech exercised its exclusive option upon amendment and restatement of the agreement. Pursuant to notice received from Genentech on June 9, 2026 in accordance with the terms of the Restated Genentech Agreement, the Restated Genentech Agreement will terminate effective August 8, 2026.
Current wording
Under the Restated Genentech Agreement, Genentech had the right to designate up to ten targets for further discovery and research utilizing our PROTAC platform technology and also had the right to remove a target from the collaboration and substitute a different target that is not an excluded target at any time prior to us commencing research on such target or in certain circumstances following commencement of research by us. The research phase of the collaboration with Genentech ended, and Genentech was no longer able to nominate new targets into the collaboration. Prior to termination, the only target that remained part of the collaboration was the PROTAC targeted protein degrader for which Genentech exercised its exclusive option upon amendment and restatement of the agreement. Pursuant to notice received from Genentech on June 9, 2026 in accordance with the terms of the Restated Genentech Agreement, the Restated Genentech Agreement terminated effective August 8, 2026.
Previous wording
Our operating expenses since inception have consisted solely of research and development costs and general and administrative costs.
Current wording
Our operating expenses since inception have consisted primarily of research and development costs and general and administrative costs and, beginning in 2026, cost of license revenue.
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Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
We have submitted our initial monotherapy dose escalation data from the ongoing Phase 1 dose escalation clinical trial of ARV-393 in patients with relapsed/refractory NHL for presentation at the 68th American Society of Hematology, or ASH, Annual Meeting in December 2026. We plan to share data from early cohorts of this ongoing trial, including safety, pharmacokinetic, or PK, and pharmacodynamic data from all patients in these early cohorts and preliminary efficacy data from patients with T-cell lymphomas. We expect that the majority of this data in 2026 will be from the early cohorts dosed below the expected efficacious range. These early monotherapy cohorts, when compared with the overall lymphoma population, include a higher-than-predicted proportion of patients with T-cell lymphomas, which we believe reflects the limited treatment options for these patients. However, as we’ve approached the predicted efficacious range, enrollment of patients, including those with B-cell lymphomas, has increased. We anticipate sharing additional monotherapy data from the ongoing Phase 1 dose escalation clinical trial of ARV-393 in patients with B- and T-cell lymphomas in mid-2027.
Current report — wording carried from elsewhere
In the second quarter of 2026, we and Pfizer entered into the Rigel License Agreement with Rigel for the exclusive global development, manufacturing, and commercialization rights for VEPPANU, which isdiscussed in greater detail below and in Note 3, Research Collaboration and License Agreements. Rigel has since then pursued the commercialization of VEPPANU, commercially launching the drug in the United States on August 13, 2026.
Current report — wording carried from elsewhere
Since inception through September 30, 2026, we raised approximately $1.7 billion in gross proceeds from the sale of assets and equity interests and the exercise of stock options and had received an aggregate of $1.0 billion in payments primarily from collaboration partners and a licensing arrangement.
Current report — wording carried from elsewhere
VEPPANU. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel.
Current report — wording carried from elsewhere
In the year ended December 31, 2018, we received an upfront non-refundable payment and certain additional payments totaling $28.0 million in exchange for use of the technology license and to fund Pfizer-related research, as defined within the Pfizer Research Collaboration Agreement. As of June 30, 2026, the research program term under the Pfizer Research Collaboration Agreement had concluded and no targets remained. Pursuant to notice received from Pfizer on August 25, 2026 in accordance with the terms of the Pfizer Research Collaboration Agreement, the Pfizer Research Collaboration Agreement terminated effective October 25, 2026.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
In addition, on May 8, 2026, the National Comprehensive Cancer Network® (NCCN®) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Previous report — wording carried elsewhere
We do not expect to generate any revenue from product sales in the near future, if ever.
Previous report — wording carried elsewhere
Pfizer will share equally in this reimbursement and therefore we will reimburse Pfizer for 50% of the costs of such activities.
Previous report — wording carried elsewhere
General and administrative expenses totaled $24.0 million for the three months ended June 30, 2026, compared to $25.3 million for the three months ended June 30, 2025. The decrease of $1.3 million was primarily due to decreases in personnel and infrastructure related costs of $3.9 million and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, inclusive of an increase in the amortization of costs to obtain a contract related to the Pfizer Letter Agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement and professional fees related tothe Rigel License Agreement.