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ARVINAS, INC.

ARVN
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Business Summary

Arvinas, Inc. is a clinical-stage biotechnology company focused on improving the lives of patients with debilitating and life-threatening diseases through its PROteolysis TArgeting Chimera (PROTAC) protein degradation platform. The company's core business model revolves around the discovery, development, and potential commercialization of novel protein degraders, which are designed to harness the body's natural protein disposal system to selectively degrade disease-causing proteins. Revenue generation is currently through collaborations and is not yet from product sales, with profitability not anticipated for several years . The company's primary customer segments are patients suffering from oncology and neurodegenerative diseases. The PROTAC Discovery Engine is a proprietary platform that leverages targeted protein degradation to address disease biology not amenable to traditional small-molecule or biologic approaches, focusing on genetically defined or under-drugged targets.

The company's pipeline includes several clinical-stage product candidates. ARV-102 is an oral PROTAC LRRK2 degrader for neurodegenerative diseases like Parkinson's disease (PD) and progressive supranuclear palsy (PSP). ARV-806 is a novel oral PROTAC KRAS G12D degrader for cancers with the G12D mutation, such as pancreatic, colorectal, and non-small cell lung cancer (NSCLC). ARV-393 is an oral PROTAC BCL6 degrader for relapsed/refractory non-Hodgkin lymphoma (NHL). ARV-027 is an oral, peripherally restricted PROTAC polyQ-AR degrader for spinal bulbar muscular atrophy (SBMA). Vepdegestrant is an oral PROTAC ER degrader for ER+/HER2- locally advanced or metastatic breast cancer. Preclinical programs include ARV-6723, an oral PROTAC HPK1 degrader for solid malignancies, and a pan-KRAS degrader targeting multiple KRAS variants.

For the fiscal year ended December 31, 2025, Arvinas reported a net loss of $80.8 million , an improvement from a net loss of $198.9 million in 2024 and $367.3 million in 2023. The accumulated deficit as of December 31, 2025, was $1,612.4 million . The company had cash, cash equivalents, and marketable securities of approximately $685.4 million as of December 31, 2025.

Year-over-year comparisons show a significant reduction in net losses, from $367.3 million in 2023 to $198.9 million in 2024, and further to $80.8 million in 2025. This trend indicates a narrowing of operating losses. The company's cash position increased to $685.4 million in 2025.

Significant operational developments during the period include the FDA's acceptance of the New Drug Application (NDA) for vepdegestrant, with a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026 . In the third quarter of 2025, Arvinas and Pfizer agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant . The company also 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 completed dose escalation for once-weekly administration ahead of plan in the first quarter of 2026 . Enrollment in the multiple dose cohort of the ARV-102 Phase 1 clinical trial in patients with PD was completed in the fourth quarter of 2025 . In the second quarter of 2024, Arvinas completed a transaction with Novartis Pharma AG, granting Novartis an exclusive worldwide license for luxdegalutamide (ARV-766) and selling rights to a PROTAC protein degrader targeting AR-V7 . This transaction included an upfront payment of $150.0 million and a $20.0 million development milestone payment received in 2025. The company also implemented workforce reductions of approximately 33% in April 2025 and an additional 15% in September 2025 to streamline operations.

Business Outlook

Management believes that the company's cash, cash equivalents, and marketable securities of approximately $685.4 million as of December 31, 2025, will be sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028 . This estimate is based on current operating plans and assumptions that may prove incorrect.

A major growth area is the advancement of the current oncology and neurology pipeline through anticipated data milestones to evaluate safety, efficacy, and biological activity, with the objective of demonstrating therapeutic differentiation to existing therapies. For ARV-102, the company plans to present data from the multiple dose cohort of the Phase 1 clinical trial in patients with PD in the first quarter of 2026 at the 2026 AD/PD conference. Pending regulatory feedback, Arvinas plans to initiate a Phase 1b clinical trial of ARV-102 in patients with PSP in the first half of 2026 and has the potential to initiate a registrational trial of ARV-102 in PSP in late 2026 . For ARV-806, the company anticipates sharing initial clinical data in patients with solid tumors harboring KRAS G12D mutations in 2026 . For ARV-393, updated clinical data from the ongoing Phase 1 clinical trial in patients with relapsed/refractory NHL are planned for a medical congress in the second half of 2026 , and enrollment of a glofitamab combination cohort in patients with DLBCL in the ongoing Phase 1 clinical trial is planned for the first half of 2026 . For ARV-027, a first-in-human Phase 1 clinical trial in healthy volunteers was initiated in the first quarter of 2026 . For vepdegestrant, the FDA has assigned a PDUFA date of June 5, 2026 . In the preclinical stage, pending regulatory feedback, Arvinas plans to initiate a Phase 1 clinical trial of ARV-6723 in patients with advanced solid tumors in mid-2026 . The company also plans to present preclinical data evaluating antitumor and unique immunomodulatory activity of ARV-6723 in immuno-oncology-resistant models compared to SOC checkpoint inhibition in the first half of 2026 , and preclinical data evaluating the activity and selectivity of a novel pan-KRAS degrader in multiple KRAS mutants and differentiation over RAS (ON) or pan-KRAS inhibitors in the first quarter of 2026 . Additionally, preclinical data evaluating the efficacy of a novel pan-KRAS degrader in a KRAS syngeneic model, as well as associated immune microenvironment changes, are planned for the first half of 2026 .

Operational outlook includes a focus on expanding the capabilities of the PROTAC Discovery Engine and the breadth of the intellectual property portfolio to support the discovery and optimization of next-generation targeted protein degraders. The company aims to accelerate discovery of TPD therapeutics, translating biological insight into efficient drug design.

Planned capital allocation includes continued significant expenses in connection with ongoing activities, particularly clinical trials and preclinical programs. The company expects to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution if it chooses to commercialize any other product candidates itself . The company received an upfront payment of $150.0 million and a $20.0 million development milestone payment from Novartis in 2025. Arvinas is eligible to receive up to an additional $1.01 billion in contingent payments from Novartis based on specified development, regulatory, and commercial milestones for luxdegalutamide (ARV-766), as well as tiered royalties on worldwide net sales. Under the Pfizer Research Collaboration Agreement, Arvinas is eligible to receive up to an additional $3.8 million in non-refundable option payments and up to $225.0 million in development milestone payments and up to $550.0 million in sales-based milestone payments for all designated targets, plus mid- to high-single digit tiered royalties. For vepdegestrant, Arvinas is eligible to receive up to an additional $1.4 billion in contingent payments based on specified regulatory and sales-based milestones, with $400 million in regulatory milestones and $1.0 billion in sales-based milestones.

Management explicitly flagged several structural headwinds and execution risks to the growth plan. The company's cost savings plan and associated workforce reductions in April 2025 (approximately 33% ) and September 2025 (additional 15% ) may not result in anticipated savings, could lead to higher-than-expected costs, and could disrupt business operations. These reductions could also harm the ability to attract and retain qualified personnel. Changes in U.S. and international trade policies, particularly with respect to China and India where drug substance building blocks are manufactured, may adversely impact business and operating results. The current tariff on goods from China is 20% and from India is 18% , with a potential 100% tariff on branded or patented drugs imported into the U.S. beginning October 1, 2025 , if manufacturing facilities are not built in the U.S. or MFN drug pricing agreements are not entered into. The BIOSECURE Act, signed into law on December 18, 2025 , limits U.S. government procurement from and grants to biotechnology companies of concern, which could restrict or prohibit the ability to work with certain Chinese biotechnology companies.

Risk Factors

The company faces significant financial risks, having incurred net losses of $80.8 million in 2025 and an accumulated deficit of $1,612.4 million . There is a substantial need for additional funding to continue operations, and the inability to raise capital could lead to delays or termination of research and development programs. The PROTAC technology platform is unproven, making development time and cost difficult to predict, and there is no guarantee of successful product development or commercialization. Product candidates may cause unexpected adverse effects, leading to abandonment or limited development. Positive preclinical or early clinical data may not be predictive of later-stage trial results, and delays in patient enrollment could hinder marketing approvals. The company's limited resources may be expended on less profitable product candidates. Dependence on third parties for clinical trials and manufacturing poses risks of unsatisfactory performance, supply disruptions, and increased costs. Disruptions at regulatory agencies, such as the FDA, due to funding cuts, personnel losses, or regulatory reform, could delay product approvals. Changes in U.S. and international trade policies, including tariffs of 20% on goods from China and 18% from India, and potential 100% tariffs on imported branded drugs, could increase costs and disrupt supply chains. The BIOSECURE Act could restrict collaborations with certain Chinese biotechnology companies. Even with marketing approval, products may fail to achieve market acceptance due to competition, pricing, or side effects. Product liability lawsuits pose a risk of substantial liabilities. The regulatory approval process is lengthy and unpredictable, with no guarantee of approval, and any approvals may come with restrictions. Failure to obtain foreign marketing approvals would limit market potential. Compliance with global privacy and data security requirements, including GDPR, could result in additional costs and liabilities, with potential fines up to €20 million or 4% of annual global revenues . Changes in tax laws, such as the 1% excise tax on stock repurchases introduced by the Inflation Reduction Act, could adversely affect financial condition. The company also has $533.6 million of federal net operating loss carryforwards and $563.2 million of state and local net operating loss carryforwards as of December 31, 2025, which may be subject to limitations on utilization.

Management Priorities

Management's message to shareholders emphasizes the company's dedication to improving patient lives through its PROTAC protein degradation platform, focusing on the discovery, development, and commercialization of novel protein degraders. They highlight the progress of seven programs into clinical trials in oncology and neurology, with vepdegestrant being the most advanced product candidate, for which the FDA has accepted an NDA and assigned a PDUFA action date of June 5, 2026 . Management believes that favorable clinical trial results in ongoing oncology and neurology programs would further validate the platform as a new therapeutic modality. The strategic priorities include advancing the current oncology and neurology pipeline through anticipated data milestones to evaluate safety, efficacy, and biological activity, with the objective of demonstrating therapeutic differentiation to existing therapies; utilizing the PROTAC Discovery Engine to expand the pipeline with a focus on historically undruggable and difficult-to-drug targets; and selectively collaborating to realize the full value of the pipeline and platform. Management also noted that the company's cash, cash equivalents, and marketable securities of approximately $685.4 million as of December 31, 2025, are expected to fund planned operating expenses and capital expenditure requirements into the second half of 2028 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Our Strategy
  3. [3] Item 1, Business — Our Focus - PROTAC Degradation and its Potential Benefits
  4. [4] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need For Additional Capital
  5. [5] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need For Additional Capital
  6. [6] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need For Additional Capital
  7. [7] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need For Additional Capital
  8. [8] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need For Additional Capital
  9. [9] Item 1, Business — Our Clinical Stage Programs — Vepdegestrant: Oral PROTAC ER Degrader Program
  10. [10] Item 1, Business — Our Clinical Stage Programs — Vepdegestrant: Oral PROTAC ER Degrader Program
  11. [11] Item 1, Business — Our Clinical Stage Programs — ARV-806: Novel PROTAC KRAS G12D Degrader Program
  12. [12] Item 1, Business — Our Clinical Stage Programs — ARV-806: Novel PROTAC KRAS G12D Degrader Program
  13. [13] Item 1, Business — Our Clinical Stage Programs — ARV-102: Oral PROTAC LRRK2 Degrader Program
  14. [14] Item 1, Business — Licenses and Strategic Collaborations — Novartis Transaction
  15. [15] Item 1, Business — Licenses and Strategic Collaborations — Novartis Transaction
  16. [16] Item 1, Business — Licenses and Strategic Collaborations — Novartis Transaction
  17. [17] Item 1A, Risk Factors — Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
  18. [18] Item 1A, Risk Factors — Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
  19. [19] Item 1A, Risk Factors — We will need substantial additional funding to continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate our research or product development programs or future commercialization efforts.
  20. [20] Item 1, Business — Our Clinical Stage Programs — ARV-102: Oral PROTAC LRRK2 Degrader Program
  21. [21] Item 1, Business — Our Clinical Stage Programs — ARV-102: Oral PROTAC LRRK2 Degrader Program
  22. [22] Item 1, Business — Our Clinical Stage Programs — ARV-102: Oral PROTAC LRRK2 Degrader Program
  23. [23] Item 1, Business — Our Clinical Stage Programs — ARV-806: Novel PROTAC KRAS G12D Degrader Program
  24. [24] Item 1, Business — Our Clinical Stage Programs — ARV-393: Oral PROTAC BCL6 Degrader Program
  25. [25] Item 1, Business — Our Clinical Stage Programs — ARV-393: Oral PROTAC BCL6 Degrader Program
  26. [26] Item 1, Business — Our Clinical Stage Programs — ARV-027: Oral PROTAC polyQ-AR Degrader Program
  27. [27] Item 1, Business — Our Preclinical Programs — Oncology, ARV-6723: Oral PROTAC HPK1 Degrader Program, and pan-KRAS Degrader Programs
  28. [28] Item 1, Business — Our Preclinical Programs — Oncology, ARV-6723: Oral PROTAC HPK1 Degrader Program, and pan-KRAS Degrader Programs
  29. [29] Item 1, Business — Our Preclinical Programs — Oncology, ARV-6723: Oral PROTAC HPK1 Degrader Program, and pan-KRAS Degrader Programs
  30. [30] Item 1, Business — Our Preclinical Programs — Oncology, ARV-6723: Oral PROTAC HPK1 Degrader Program, and pan-KRAS Degrader Programs
  31. [31] Item 1A, Risk Factors — We will need substantial additional funding to continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate our research or product development programs or future commercialization efforts.
  32. [32] Item 1, Business — Licenses and Strategic Collaborations — Novartis Transaction
  33. [33] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Research Collaboration Agreement
  34. [34] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Research Collaboration Agreement
  35. [35] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Research Collaboration Agreement
  36. [36] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Vepdegestrant (ARV-471) Collaboration Agreement
  37. [37] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Vepdegestrant (ARV-471) Collaboration Agreement
  38. [38] Item 1, Business — Licenses and Strategic Collaborations — Pfizer Vepdegestrant (ARV-471) Collaboration Agreement
  39. [39] Item 1A, Risk Factors — Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  40. [40] Item 1A, Risk Factors — Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  41. [41] Item 1A, Risk Factors — Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  42. [42] Item 1A, Risk Factors — Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  43. [43] Item 1, Business — Government Regulation and Product Approvals — General Data Protection Regulation
  44. [44] Item 1A, Risk Factors — Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  45. [45] Item 1A, Risk Factors — In the future, we might not be able to utilize a significant portion of any net operating loss carryforwards and research and development tax credit carryforwards we may have.
  46. [46] Item 1A, Risk Factors — In the future, we might not be able to utilize a significant portion of any net operating loss carryforwards and research and development tax credit carryforwards we may have.

Analysis on 5/22/2026