Financial Data and Key Metrics Changes - As of the end of Q3 2025, the company had approximately $787.6 million in cash, cash equivalents, and marketable securities, down from $1.04 billion as of December 31, 2024 [31] - Revenue for Q3 2025 totaled $41.9 million, a decrease of $60.5 million compared to $102.4 million for Q3 2024, primarily due to the Novartis License agreement [31][32] - General and Administrative expenses were $21 million in Q3 2025, down from $75.8 million in the same period of 2024, mainly due to lease termination and reduced personnel costs [32] - Research and Development expenses were $64.7 million in Q3 2025, compared to $86.9 million in Q3 2024, driven by decreases in various programs [33] Business Line Data and Key Metrics Changes - The company reported significant progress in its clinical pipeline, including updates on ARV-102, ARV-393, and ARV-806, with multiple ongoing and planned clinical trials [12][14][27] - ARV-102 showed promising results in both healthy volunteers and Parkinson's disease patients, with significant reductions in LRRK2 protein levels [19][20][21] - ARV-393 demonstrated early responses in both B and T cell lymphomas, with ongoing dose escalation trials [25][26] Market Data and Key Metrics Changes - The company is focused on addressing significant unmet needs in oncology and neurology, with a deep pipeline of assets [13][14] - The FDA has issued a PDUFA action date of June 5, 2026, for the new drug application of vepdegestrant, with plans to have a commercialization partner in place before this date [15] Company Strategy and Development Direction - The company aims to deliver innovative and differentiated assets in areas of high unmet need, with a focus on progressing its early pipeline [37] - The strategic partnership with Pfizer for the commercialization of vepdegestrant is expected to enhance the company's market position [15] - The company is committed to maintaining a quarterly run rate spend below $75 million to manage expenses effectively [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for ARV-102 and its ability to address neurodegenerative diseases, with plans for a phase 1b trial in PSP [12][37] - The company anticipates a data-rich period with multiple readouts from early-stage clinical programs, reinforcing its belief in the promise of its pipeline [13][14] - Management highlighted the importance of cost reduction programs and strategic flexibility to navigate the evolving market landscape [34] Other Important Information - The company has authorized the repurchase of up to $100 million of its outstanding common stock, reflecting confidence in its long-term strategy [34] - The company expects to maintain its cash runway into the second half of 2028, allowing for continued investment in high-value assets [36] Q&A Session Summary Question: Updates on the BCL6 degrader program - Management expressed excitement about the BCL6 program and its differentiation from competitors, highlighting ongoing studies and expected data at the upcoming ASH meeting [45][48] Question: Signals to look for in the Parkinson's disease MAD phase one - Management indicated that the ongoing phase one study aims to generate biomarker-related data, with expectations for clinical efficacy data to follow [54][56] Question: Plans for ARV806 in KRAS amplified populations - The company is studying ARV806 in resistance settings and has seen promising early data in models of KRAS amplification [61][63] Question: Dosing cohorts for ARV393 - Management confirmed that they are not yet in the predicted efficacious range for ARV393 but are seeing significant responses at lower dose levels [129][139] Question: Evaluating combination strategies for ARV806 - The company has preclinically evaluated combinations with anti-EGFR inhibitors and believes this selective approach will provide advantages [89][91]

Financial Performance - Revenue for Q3 2025 was $41.9 million, a decrease of $60.5 million compared to $102.4 million in Q3 2024, primarily due to reduced revenue from the Novartis License Agreement[18] - Revenue for Q3 2025 was $41.9 million, a decrease from $102.4 million in Q3 2024, representing a decline of 59%[39] - For the nine months ended September 30, 2025, revenue was $253.1 million, up from $204.2 million in the same period of 2024, an increase of 24%[39] - Net loss for Q3 2025 was $35.1 million, an improvement from a net loss of $49.2 million in Q3 2024, reflecting a 29% reduction in losses[39] - Loss per common share for Q3 2025 was $0.48, compared to $0.68 in Q3 2024, indicating a 29% improvement[39] - Interest and other income for Q3 2025 was $9.0 million, compared to $11.7 million in Q3 2024, a decrease of 23%[39] Expenses - GAAP Research and Development (R&D) expenses for Q3 2025 were $64.7 million, down from $86.9 million in Q3 2024, a decrease of $22.2 million[14] - GAAP General and Administrative (G&A) expenses for Q3 2025 were $21.0 million, significantly reduced from $75.8 million in Q3 2024, a decrease of $54.8 million[16] - Total operating expenses for Q3 2025 were $85.7 million, down from $162.7 million in Q3 2024, a reduction of 47%[39] - Research and development expenses for Q3 2025 were $64.7 million, compared to $86.9 million in Q3 2024, a decrease of 25%[39] - Non-GAAP research and development expenses for Q3 2025 were $56.9 million, down from $73.2 million in Q3 2024, a decrease of 22%[41] - Non-GAAP general and administrative expenses for Q3 2025 were $14.6 million, compared to $64.8 million in Q3 2024, a significant reduction of 77%[41] Cash and Assets - As of September 30, 2025, cash, cash equivalents, and marketable securities were $787.6 million, down from $1,039.4 million as of December 31, 2024, reflecting a decrease of $251.8 million[12] - As of September 30, 2025, Arvinas reported total current assets of $826.3 million, down from $1,067.3 million as of December 31, 2024[37] - Total liabilities decreased to $279.9 million from $529.7 million over the same period[37] - The accumulated deficit increased to $(1,545.0) million as of September 30, 2025, compared to $(1,531.6) million at the end of 2024[37] Clinical Trials and Drug Development - ARV-102 showed greater than 90% reductions of LRRK2 protein in peripheral blood mononuclear cells and over 50% reductions in cerebrospinal fluid with repeated daily doses[4] - ARV-806 demonstrated in vitro potency approximately 25 times greater than KRAS inhibitors and 40 times greater than the leading clinical-stage degrader[7] - The FDA accepted the New Drug Application for vepdegestrant, with a PDUFA action date set for June 5, 2026[7] - The company plans to initiate a Phase 1b clinical trial for ARV-102 in patients with progressive supranuclear palsy in the first half of 2026[12] - ARV-393 is currently in a Phase 1 clinical trial for relapsed/refractory non-Hodgkin lymphoma, targeting BCL6, a major driver of B-cell lymphomas[23] - ARV-806, designed to degrade KRAS G12D, is also in a Phase 1 clinical trial for advanced solid tumors, addressing high unmet needs in cancers like pancreatic and colorectal[24] - ARV-027, targeting polyQ-AR for spinal and bulbar muscular atrophy, plans to initiate a Phase 1 clinical trial in healthy volunteers in 2026[26] - ARV-6723, aimed at degrading HPK1 in immuno-oncology, is set to begin a Phase 1 clinical trial in 2026[27] - Vepdegestrant showed significant improvement in progression-free survival in the VERITAC-2 Phase 3 study for ER+/HER2- ESR1-mutated breast cancer, with an NDA filed with the FDA[28] - Arvinas and Pfizer announced a global collaboration for the co-development and commercialization of vepdegestrant, sharing development costs and profits[29] Research and Development Strategy - The company aims to drive innovation across its PROTAC degrader portfolio and deliver transformative therapies to patients[3] - Arvinas plans to present initial data from multiple clinical trials and share preclinical data at upcoming medical congresses, indicating ongoing research and development efforts[32]

Core Insights - Arvinas, Inc. reported significant progress in its clinical pipeline, including positive Phase 1 trial data for ARV-102 in Parkinson's disease and promising preclinical results for ARV-806 and ARV-027 [1][3][6][11] - The company announced a collaboration with Pfizer for the commercialization and further development of vepdegestrant, an investigational drug for breast cancer [1][10][30] - Financial results for Q3 2025 showed a decrease in revenue and operating expenses, with cash reserves sufficient to fund operations into the second half of 2028 [14][15][21] Clinical Developments - ARV-102 demonstrated well-tolerated results in healthy volunteers and Parkinson's patients, with significant reductions in LRRK2 protein levels [6][24] - ARV-806 showed robust anti-tumor activity in preclinical models of KRAS G12D-mutant cancers, with a Phase 1 trial initiated [11][26] - ARV-027 exhibited effective degradation of polyQ-AR in muscle, supporting its potential as a disease-modifying therapy for spinal bulbar muscular atrophy [1][9][27] Financial Performance - Revenue for Q3 2025 was $41.9 million, down from $102.4 million in Q3 2024, primarily due to decreased revenue from previous collaborations [21] - Research and development expenses decreased to $64.7 million from $86.9 million year-over-year, reflecting reduced external costs [16] - The company reported a net loss of $35.1 million for Q3 2025, compared to a loss of $49.2 million in the same quarter of the previous year [39] Strategic Collaborations - The agreement with Pfizer aims to enhance the commercialization potential of vepdegestrant, with plans to select a third-party partner for further development [10][30] - The collaboration underscores the strategic focus on bringing innovative therapies to market, particularly in oncology and neurodegenerative diseases [1][23] Future Outlook - Arvinas plans to initiate multiple clinical trials in 2026, including a Phase 1b trial for ARV-102 in progressive supranuclear palsy and a trial for ARV-027 [1][12][29] - The company is positioned for a data-rich period with several upcoming readouts from its clinical programs, aiming to drive innovation in its PROTAC degrader portfolio [3][10]

Core Viewpoint - Arvinas, Inc. is advancing its investigational drug ARV-393, a PROTAC designed to degrade the BCL6 protein, which is a significant driver of B-cell lymphomas, and will present preclinical data in December 2025 at the ASH Annual Meeting [1][3]. Group 1: About ARV-393 - ARV-393 targets the BCL6 protein, which plays a crucial role in B-cell lymphoma by repressing cell cycle checkpoints and apoptosis, making it a challenging target for traditional therapies [3]. - The drug is currently in a Phase 1 clinical trial for patients with non-Hodgkin lymphoma, indicating its potential therapeutic application in this area [3]. Group 2: About Arvinas - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize its PROTAC platform to selectively degrade disease-causing proteins [4]. - The company is also developing other investigational drugs, including ARV-102 for neurodegenerative disorders, ARV-806 for mutated cancers, and vepdegestrant for ER+/HER2-breast cancer [4].

Core Insights - Arvinas, Inc. is set to review its third-quarter 2025 financial results and provide a corporate update on November 5, 2025 [1] - The company specializes in targeted protein degradation therapies through its PROTAC platform, aiming to treat various debilitating diseases [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies for life-threatening diseases [3] - The company utilizes its PROTAC (PROteolysis TArgeting Chimera) platform to create drugs that selectively degrade disease-causing proteins [3] - Current investigational drugs include ARV-102 for neurodegenerative disorders, ARV-393 for non-Hodgkin Lymphoma, ARV-806 for mutated cancers, and vepdegestrant for ER+/HER2- breast cancer [3]

Core Insights - Arvinas, Inc. announced preclinical data for ARV-806, a PROTAC KRAS G12D degrader, demonstrating significant tumor growth inhibition in models of pancreatic, colorectal, and lung cancer, highlighting its best-in-class potential for KRAS G12D mutated cancers [1][2][5] Group 1: Drug Development and Efficacy - ARV-806 showed robust and durable KRAS G12D degradation, leading to significant tumor growth inhibition in various cancer models [1] - The drug targets both ON and OFF forms of KRAS G12D, which is the most common mutation of the KRAS protein, addressing high unmet needs in solid tumors [1][5] - In vitro studies indicated that ARV-806 degraded KRAS G12D with picomolar potency across multiple cancer cell lines without affecting wild-type and other mutant RAS isoforms [6] - Following a single intravenous dose, ARV-806 achieved over 90% degradation of KRAS G12D for seven days, with sustained effects on c-MYC suppression and BIM induction for at least five days [6] Group 2: Clinical Trials and Future Potential - Arvinas is currently evaluating ARV-806 in a Phase 1 clinical trial for patients with KRAS G12D–mutated advanced solid tumors [3] - The data suggest that ARV-806's sustained pharmacodynamic activity supports intermittent clinical dosing, indicating a potential for effective treatment regimens [3][8] - The drug demonstrated over 25-fold greater potency in reducing cancer cell proliferation and over 40-fold higher potency in degrading KRAS G12D protein compared to other clinical-stage G12D degraders [6] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies through its PROTAC platform, targeting various diseases including cancers with KRAS mutations [7] - The company is advancing multiple investigational drugs, including ARV-806 for KRAS G12D, vepdegestrant for ER+/HER2- breast cancer, and ARV-393 for non-Hodgkin lymphoma [7]

Core Insights - Arvinas, Inc. announced the presentation of preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [1] - ARV-806 targets the KRAS G12D mutation, which is prevalent in various solid tumors, indicating a significant unmet medical need [2] - The company is advancing multiple investigational drugs, including ARV-806, through clinical development programs [3] Group 1: ARV-806 Presentation Details - Title of the presentation: Preclinical Activity of ARV-806, a PROTAC KRAS G12D Degrader [1] - Presentation type: Poster presentation, scheduled for October 24, 2025, from 12:30-4pm ET [1] - Poster number: B107, part of Poster Session B [1] Group 2: About ARV-806 - ARV-806 is designed to selectively target and degrade the KRAS G12D mutation, which is the most common mutation of the KRAS protein [2] - The drug is currently in a Phase 1 clinical trial for patients with advanced solid tumors harboring KRAS G12D mutations [2] Group 3: About Arvinas - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize the body's natural protein disposal system [3] - The company is also developing other investigational drugs targeting various conditions, including breast cancer and neurodegenerative disorders [3] - Arvinas is headquartered in New Haven, Connecticut [3]

Group 1 - Arvinas, Inc. (ARVN) shares have increased by 28.3% over the past four weeks, closing at $9.66, with a mean price target of $12.13 indicating a potential upside of 25.6% [1] - The mean estimate consists of 16 short-term price targets with a standard deviation of $3.58, where the lowest estimate is $6.00 (indicating a 37.9% decline) and the highest is $18.00 (indicating an 86.3% increase) [2] - Analysts show a strong consensus that ARVN will report better earnings than previously estimated, which is a positive indicator for potential stock upside [4][11] Group 2 - The Zacks Consensus Estimate for ARVN's current year earnings has increased by 12.8% over the last 30 days, with one estimate moving higher and no negative revisions [12] - ARVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential for near-term upside [13] - While the consensus price target may not be a reliable indicator of the extent of ARVN's gains, it does provide a useful guide for the direction of price movement [14]

Core Insights - Vepdegestrant has shown statistically significant improvements in patient-reported outcomes (PROs) compared to fulvestrant, particularly in quality of life, pain, and daily functioning for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer [1][2][3] Clinical Trial Findings - The Phase 3 VERITAC-2 clinical trial demonstrated that vepdegestrant delayed deterioration in overall health status, pain severity, and various functioning domains compared to fulvestrant [2][3] - The trial enrolled 624 patients, with 270 having ESR1 mutations, and the primary endpoint was progression-free survival (PFS) [7][8] - Vepdegestrant was administered orally once daily, while fulvestrant was given intramuscularly [8] Company Collaboration and Development - Arvinas is collaborating with Pfizer for the co-development and commercialization of vepdegestrant, sharing development costs and profits [10] - The FDA has accepted the New Drug Application (NDA) for vepdegestrant, granting it Fast Track designation, indicating a significant unmet need in the target patient population [11] Additional Clinical Insights - Results from the TACTIVE-N Phase 2 clinical trial indicated that neoadjuvant vepdegestrant showed biological and clinical activity in postmenopausal women with localized ER+/HER2- breast cancer [5] - The data from the VERITAC-2 trial support vepdegestrant's potential as a best-in-class therapy for the specified patient group [4]

Core Insights - Arvinas, Inc. is set to present new patient-reported outcomes data for vepdegestrant at the ESMO Congress from October 17 to 21, 2025, highlighting its potential as a treatment for advanced or metastatic breast cancer with ESR1 mutations [1][2] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies to treat life-threatening diseases, utilizing its PROTAC platform [6][7] - The company is headquartered in New Haven, Connecticut, and is advancing multiple investigational drugs, including vepdegestrant for breast cancer and others targeting various cancers and neurodegenerative disorders [7] Product Development - Vepdegestrant is an investigational PROTAC estrogen receptor degrader being developed as a monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations [3][5] - The FDA has accepted the New Drug Application for vepdegestrant, granting it Fast Track designation, indicating its potential as a new treatment option for patients previously treated with endocrine-based therapy [5] Collaboration and Commercialization - In July 2021, Arvinas entered a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant, with plans announced in September 2025 to select a third party for out-licensing and commercialization [4]