– First-ever FDA approved PROTAC supports the further development and potential of Arvinas’ pipeline –
– Announced FDA Approval of VEPPANU™ (vepdegestrant) for the treatment of ESR1m, ER+/HER2- advanced breast cancer –
– Announced selection of Rigel Pharmaceuticals for the exclusive global rights to VEPPANU –
– Presented ARV-102 (LRRK2 degrader) Phase 1 clinical data in patients with Parkinson’s disease demonstrating reduction in endolysosomal and neuroinflammatory biomarkers implicated in Parkinson’s disease and progressive supranuclear palsy –
– Presented ARV-6723 (HPK1 degrader) preclinical data at the American Associated of Cancer Research Annual meeting demonstrating the potential to overcome immune checkpoint inhibitor resistance in solid tumors –
– Initiated dosing with ARV-027 (polyQ-AR degrader) in Phase 1 healthy volunteer trial with single-ascending dose data anticipated in 2H26 –
– Company to host conference call today at
“The approval of VEPPANU is a defining achievement for
1Q 2026 Business Highlights and Recent Developments
Approved Product
VEPPANU™ (vepdegestrant): Oral PROTAC ER degrader
As part of
- Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
- This approval marks the first time the
U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.
- This approval marks the first time the
- Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
- 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.*
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader
- Presented Phase 1 data for ARV-102 at the 2026
International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026) showing greater than 50% LRRK2 degradation in cerebrospinal fluid (CSF) of patients with Parkinson’s disease treated for 28 days. Additional key findings from the trial showed:- Reduction of key endolysosomal and neuroinflammatory biomarkers (e.g., CD68, GPNMB) previously shown to be elevated in neurodegenerative diseases like Parkinson’s disease and progressive supranuclear palsy (PSP).
- This level of biomarker modulation has not previously been demonstrated by LRRK2 inhibitors.
- Dose-dependent exposure increases in CSF after multiple doses, indicating brain penetration.
- Approximately 50% or greater LRRK2 reduction in CSF at all doses by day 14 and maintained through day 28, indicating substantial central LRRK2 protein degradation.
- ARV-102 was generally safe and well tolerated with no serious adverse events reported after multiple doses.
- Reduction of key endolysosomal and neuroinflammatory biomarkers (e.g., CD68, GPNMB) previously shown to be elevated in neurodegenerative diseases like Parkinson’s disease and progressive supranuclear palsy (PSP).
ARV-806: Novel PROTAC KRAS G12D degrader
- Completed dose escalation enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
ARV-393: Oral PROTAC BCL6 degrader
- Initiated a Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).
- Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin’s lymphoma (NHL).
- Multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas.
- Multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas.
ARV-027: Oral PROTAC polyQ-AR degrader
- Initiated a first-in-human Phase 1 clinical trial in healthy volunteers.
- Presented preclinical data at the 2026 Kennedy’s
Disease Association Conference .- In an aggressive spinal bulbar muscular atrophy mouse model, ARV-027 degraded polyQ-AR in muscle, which led to meaningful functional improvements and extended survival.
- In an aggressive spinal bulbar muscular atrophy mouse model, ARV-027 degraded polyQ-AR in muscle, which led to meaningful functional improvements and extended survival.
ARV-6723: Oral PROTAC HPK1 degrader
- Presented preclinical data at the
American Association for Cancer Research (AACR) Immuno-Oncology Conference that we believe support clinical investigation of ARV-6723 in patients with solid tumors harboring high- or low-immunogenic tumor microenvironments (TME), including immune checkpoint inhibitor (ICI)-resistant tumor settings.- Robust single-agent antitumor and proinflammatory activity observed in multiple syngeneic tumor models, including those with immunosuppressive TMEs, and showed greater preclinical activity than an investigational HPK1 inhibitor or an anti-PD-1 antibody.
- Presented preclinical data at the AACR Annual Meeting demonstrating greater antitumor activity than standard-of-care ICIs or an investigational HPK1 inhibitor.
- Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive TME, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.
Novel pan-KRAS degrader:
- Presented preclinical data at the
AACR Special Conference inCancer Research :RAS Oncogenesis and Therapeutics.- Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
- Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
- Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.
Corporate
- Announced the appointment of
Randy Teel , Ph.D., as President, Chief Executive, and Director.Dr. Teel succeedsJohn Houston , Ph.D., who retired from his role as President, Chief Executive Officer, and Chair of Arvinas’ Board of Directors.Dr. Houston will continue to serve as a member of the Board and has entered into a consulting agreement withArvinas to provide consulting and advisory services to the Company.Briggs Morrison , M.D., was elected by the Board to serve as Chair of the Arvinas Board of Directors.
Anticipated Upcoming Milestones and Expectations
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader
- Initiate Phase 1b clinical trial in patients with PSP upon receipt of FDA clearance to proceed (2H 2026, pending regulatory feedback).
- Potential to initiate a registrational trial in PSP in late 2026, pending regulatory feedback.
- Share additional biomarker data from Phase 1 trial in patients with Parkinson’s disease (2H 2026).
ARV-806: Novel PROTAC KRAS G12D degrader
- Initiate enrollment in the dose expansion cohort of the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
- Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026).
ARV-393: Oral PROTAC BCL6 degrader
- Share updated clinical data from the ongoing Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin’s lymphoma (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
- Continue enrollment of a combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial.
ARV-027: Oral PROTAC polyQ-AR degrader
- Continue enrollment in the Phase 1 clinical trial in healthy volunteers.
ARV-6723: Oral PROTAC HPK1 degrader
- Initiate Phase 1 clinical trial in patients with advanced solid tumors (mid-2026).
- ARV-6723 is Arvinas’ first immuno-oncology clinical candidate.
Approved Product
VEPPANU™ (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:
- Complete closing of the licensing transaction of VEPPANU to Rigel, which is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Financial Guidance
Based on its current operating plan,
First Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of
Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were
Non-GAAP R&D expenses were
General and Administrative Expenses: GAAP General and administrative (G&A) expenses were
Non-GAAP G&A expenses were
Revenue: Revenue was
Investor Call & Webcast Details
About Arvinas
About ARV-102
ARV-102 is an investigational, orally bioavailable PROTAC designed to cross the blood-brain barrier and specifically target and degrade leucine-rich repeat kinase (LRRK2), a large, multidomain scaffolding kinase with GTPase activity. Increased activity and over expression of LRRK2 have been implicated in the pathogenesis of neurological diseases, including LRRK2 genetic and idiopathic Parkinson’s disease and progressive supranuclear palsy (PSP). ARV-102 is currently being evaluated in a Phase 1 clinical trial in patients with Parkinson’s disease and
About ARV-806
ARV806 is a novel, investigational PROTAC designed to selectively target and degrade mutant Kirsten rat sarcoma (KRAS) G12D. KRAS is one of the most frequently mutated human oncogenes and G12D is the most common mutation of the KRAS protein. ARV-806 has demonstrated potent, selective degradation of KRAS G12D and robust anti-tumor activity in preclinical models. ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer, and is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors harboring KRAS G12D mutations.
About ARV-393
ARV-393 is an investigational, orally bioavailable PROTAC designed to specifically target and degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6. ARV-393 is currently being evaluated in a Phase 1 clinical trial as a monotherapy in patients with relapsed/refractory non-Hodgkin lymphoma and in in combination with glofitamab as a chemotherapy-free combination approach in patients with DLBCL.
About ARV-027
ARV-027 is an oral, peripherally restricted investigational PROTAC degrader designed to selectively target and eliminate the polyglutamine-expanded androgen receptor (polyQ-AR) in skeletal muscle. ARV-027 is a clinical candidate specifically selected for potent in vitro reduction of cytosolic and nuclear polyQ-AR and for favorable skeletal-muscle exposure following oral administration. The polyQ-AR protein is the pathogenic driver of spinal and bulbar muscular atrophy (SBMA), a rare, X-linked, genetically defined neuromuscular disease caused by a CAG trinucleotide repeat expansion in the androgen receptor (AR) gene. SBMA leads to progressive muscle weakness, dysphagia, and functional decline, and currently has no approved disease-modifying therapies approved by the FDA or EMA, representing a significant unmet medical need. ARV-027 is currently being evaluated in a fist-in-human Phase 1 clinical trial in healthy volunteers.
About ARV-6723
ARV-6723 is an oral investigational PROTAC designed to degrade hematopoietic progenitor kinase 1, or HPK1, and is Arvinas’ first clinical candidate in the immuno-oncology space. Preclinically, ARV-6723 has shown potent, selective HPK1 degradation and strong anti-tumor immune responses with superior tumor control in low- and high- immunogenic tumor models. HPK1 acts as a negative regulator in T-cell signaling. Degrading HPK1 and its scaffolding function has the potential to unleash an immune response with potent anti-tumor effects and minimum off-target toxicity.
About VEPPANU
VEPPANU (vepdegestrant) is an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), estrogen receptor degrader approved in the
Non-GAAP Financial Information
The results presented in this press release include both Generally Accepted Accounting Principles (GAAP) information and non-GAAP information. As used in this release, non-GAAP research and development (“R&D”) expense is defined by
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: Arvinas’ focus on delivering key data and clinical milestones and its belief that such data and milestones will further validate its approach and clearly distinguish its programs in an increasingly competitive environment; the therapeutic potential or potential benefits of Arvinas’ product candidates and potential of its pipeline; Arvinas’ anticipated milestones, expectations and plans with respect to ARV-102, ARV-806, ARV-393, ARV-027 and ARV-6723, including timings related to anticipated enrollment or initiation of trials and sharing or presentation of data as well as forums for presenting any such data; the closing of the outlicensing transaction of VEPPANU to Rigel; statements regarding Arvinas’ cash, cash equivalents and marketable securities, including their sufficiency to fund planned operating expenses and capital expenditure requirements into the second half of 2028; and Arvinas’ belief that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
VEPPANU is a trademark of
*NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Contacts
Investors:
+1 (347) 247-5089
Jeff.Boyle@arvinas.com
Media:
Alyssa Kuciunas
+1 (331) 481-3751
Alyssa.Kuciunas-c@arvinas.com
| Condensed Consolidated Balance Sheets (Unaudited) | |||||||
| (dollars and shares in millions, except per share amounts) | 2026 | 2025 | |||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 87.3 | $ | 142.9 | |||
| Marketable securities | 527.6 | 542.5 | |||||
| Accounts receivable | 1.8 | 1.0 | |||||
| Other receivables | 4.6 | 5.4 | |||||
| Prepaid expenses and other current assets | 9.4 | 8.9 | |||||
| Total current assets | 630.7 | 700.7 | |||||
| Property, equipment and leasehold improvements, net | 5.5 | 5.2 | |||||
| Operating lease right-of-use assets | 7.8 | 8.2 | |||||
| Collaboration contract asset and other assets | 3.5 | 3.8 | |||||
| Total assets | $ | 647.5 | $ | 717.9 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 62.3 | $ | 69.5 | |||
| Deferred revenue | 51.8 | 71.3 | |||||
| Current portion of operating lease liabilities | 1.8 | 1.7 | |||||
| Total current liabilities | 115.9 | 142.5 | |||||
| Deferred revenue | 138.2 | 134.3 | |||||
| Long-term debt | 0.3 | 0.4 | |||||
| Operating lease liabilities | 6.3 | 6.8 | |||||
| Total liabilities | 260.7 | 284.0 | |||||
| Stockholders’ equity: | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 0.1 | 0.1 | |||||
| Accumulated deficit | (1,670.0 | ) | (1,612.4 | ) | |||
| Additional paid-in capital | 2,149.0 | 2,136.9 | |||||
| Accumulated other comprehensive (loss) income | (0.4 | ) | 1.2 | ||||
| Treasury Stock, at cost (10.0 shares as of | (91.9 | ) | (91.9 | ) | |||
| Total stockholders’ equity | 386.8 | 433.9 | |||||
| Total liabilities and stockholders’ equity | $ | 647.5 | $ | 717.9 | |||
| Condensed Consolidated Statements of Operations (Unaudited) | |||||||
| For the Three Months Ended | |||||||
| (dollars and shares in millions, except per share amounts) | 2026 | 2025 | |||||
| Revenue | $ | 15.6 | $ | 188.8 | |||
| Operating expenses: | |||||||
| Research and development | 60.3 | 90.8 | |||||
| General and administrative | 19.1 | 26.6 | |||||
| Total operating expenses | 79.4 | 117.4 | |||||
| (Loss) income from operations | (63.8 | ) | 71.4 | ||||
| Interest and other income | 6.3 | 11.7 | |||||
| Net (loss) income before income taxes | (57.5 | ) | 83.1 | ||||
| Income tax expense | (0.1 | ) | (0.2 | ) | |||
| Net (loss) income | $ | (57.6 | ) | $ | 82.9 | ||
| (Loss) earnings per common share | |||||||
| Basic | $ | (0.90 | ) | $ | 1.14 | ||
| Diluted | (0.90 | ) | 1.14 | ||||
| Weighted average common shares outstanding | |||||||
| Basic | 64.0 | 72.5 | |||||
| Diluted | 64.0 | 72.7 | |||||
| Reconciliation of GAAP to Non-GAAP Information | |||||||
| For the Three Months Ended | |||||||
| (dollars in millions) | 2026 | 2025 | |||||
| Research and development reconciliation | |||||||
| GAAP research and development expenses | $ | 60.3 | $ | 90.8 | |||
| Less: restructuring expense | 0.3 | — | |||||
| Less: stock-based compensation expense (*) | 5.7 | 11.5 | |||||
| Non-GAAP research and development expenses | $ | 54.3 | $ | 79.3 | |||
| General and administrative reconciliation | |||||||
| GAAP general and administrative expenses | $ | 19.1 | $ | 26.6 | |||
| Less: restructuring expense | 0.8 | — | |||||
| Less: stock-based compensation (net reversal) expense (*) | 5.3 | 3.5 | |||||
| Non-GAAP general and administrative expenses | $ | 13.0 | $ | 23.1 | |||
(*) Excludes restructuring related stock-based compensation.
Source: 