Arvinas (ARVN) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 It is now my pleasure to turn today's call over to Arvina's Vice President of Investor Relations, Jeff Boyle. Please go ahead. Speaker1 Thank you, and good morning, everyone. Thanks for joining us. Earlier today, we issued a press release with our first quarter twenty twenty five financial results, which is available in the Investor and Media section of our website at arvinas.com. Joining the call today are John Houston, Arvinas' Chief E ...

Exhibit 99.1 Arvinas Reports First Quarter 2025 Financial Results and Provides Corporate Update – Reported positive topline results from the Phase 3 VERITAC-2 trial that support global regulatory filings – – Presented first-in-human data for the Company's first neuroscience program with ARV-102 showing blood- brain barrier penetration and central and peripheral LRRK2 degradation – ARV-102: Oral PROTAC LRRK2 degrader ARV-393: Oral PROTAC BCL6 degrader – Announced the re-prioritization of its vepdegestrant de ...

Core Insights - Arvinas, Inc. reported positive topline results from the Phase 3 VERITAC-2 trial, supporting global regulatory filings for vepdegestrant, a PROTAC treatment for metastatic breast cancer [1][6][30] - The company announced a workforce reduction of approximately one-third to extend its cash runway into the second half of 2028 [5][11][30] - Revenue for Q1 2025 was $188.8 million, a significant increase from $25.3 million in Q1 2024, primarily due to the Vepdegestrant collaboration with Pfizer [21][39] Company Developments - Vepdegestrant is positioned as a competitive monotherapy for metastatic breast cancer in the second-line ESR1 mutant setting, with plans for regulatory submission [2][24] - The company has removed two Phase 3 combination trials from its development plan, focusing instead on maximizing patient benefit and shareholder value [2][11] - Arvinas presented first-in-human data for ARV-102, showing significant LRRK2 degradation, and plans to continue its clinical trials [5][10][27] Financial Performance - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $954.3 million, down from $1,039.4 million at the end of 2024 [15] - Research and development expenses for Q1 2025 were $90.8 million, an increase from $84.3 million in Q1 2024, driven by external expenses [16][18] - General and administrative expenses rose to $26.6 million in Q1 2025 from $24.3 million in Q1 2024, primarily due to increased professional fees [19][20] Upcoming Milestones - The company plans to present detailed results from the VERITAC-2 trial at the 2025 ASCO Annual Meeting and submit a new drug application to the FDA in the second half of 2025 [17][30] - Arvinas aims to initiate a first-in-human Phase 1 trial for ARV-806 in patients with solid tumors harboring KRAS G12D mutations in the second half of 2025 [13][31] - Continued recruitment for the Phase 1 clinical trial of ARV-102 in patients with non-Hodgkin lymphoma is expected, with initial data presentation planned for the second half of 2025 [10][31]

Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing a new class of drugs based on targeted protein degradation [3] - The company is headquartered in New Haven, Connecticut and aims to improve the lives of patients with debilitating and life-threatening diseases [3] Financial Results and Corporate Update - Management will review the first quarter 2025 financial results and provide a corporate update during a live webcast on May 1, 2025, at 8:00 a.m. ET [1] - The webcast will be accessible under "Events and Presentations" on the investor page of the Arvinas website, with a replay available afterward [2] Drug Development Pipeline - Arvinas is advancing multiple investigational drugs through clinical development programs, including: - Vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer [3] - ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma [3] - ARV-102, targeting LRRK2 for neurodegenerative disorders [3] Technology Platform - The company utilizes its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform to develop therapies that selectively degrade and remove disease-causing proteins [3]

Core Insights - Arvinas, Inc. presented promising preclinical data for ARV-393, a PROTAC BCL6 degrader, showing strong synergistic antitumor activity in combination with standard-of-care treatments for aggressive B-cell lymphomas [1][2][4] Group 1: Study Findings - ARV-393 demonstrated complete tumor regressions in high-grade B-cell lymphoma and aggressive diffuse large B-cell lymphoma models when combined with standard-of-care chemotherapy and biologics [1][4] - The combination of ARV-393 with R-CHOP chemotherapy resulted in significantly greater tumor growth inhibition compared to R-CHOP or ARV-393 alone, with complete regressions observed in all treated mice [4] - Combinations of ARV-393 with investigational small molecule inhibitors targeting oncogenic drivers like BTK, BCL2, and EZH2 also led to superior tumor growth inhibition and regressions in all treated mice [4] Group 2: Clinical Development - A Phase 1 clinical trial of ARV-393 is currently enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL [2][5] - The preclinical data support the potential for broad combinability of ARV-393, providing a rationale for further exploration of combination strategies in lymphoma treatment [2][5] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies based on targeted protein degradation, with a pipeline that includes ARV-393 for non-Hodgkin lymphoma and other investigational drugs for various conditions [6]

Core Insights - Arvinas, Inc. announced the presentation of pivotal data from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant against fulvestrant for ER+/HER2- advanced or metastatic breast cancer at the 2025 ASCO Annual Meeting [1][3] - Vepdegestrant is being co-developed with Pfizer and is designed as a potential first-in-class oral PROTAC estrogen receptor degrader [2][4] Group 1: Clinical Trial and Presentation Details - The VERITAC-2 trial results will be presented as a late-breaking oral presentation on May 31, 2025, by Dr. Erika P. Hamilton [3] - The session will focus on the comparison of vepdegestrant and fulvestrant in treating advanced breast cancer [3] Group 2: Product Information - Vepdegestrant is an investigational PROTAC protein degrader targeting the estrogen receptor for ER+/HER2- breast cancer [4] - It is being developed for use as both a monotherapy and in combination therapies across various treatment settings [4] Group 3: Collaboration and Regulatory Status - Arvinas and Pfizer entered a global collaboration for the co-development and commercialization of vepdegestrant, sharing development costs and profits [5] - The FDA has granted vepdegestrant Fast Track designation for treating adults with advanced or metastatic ER+/HER2- breast cancer previously treated with endocrine therapy [5] Group 4: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies to treat life-threatening diseases [6] - The company is advancing multiple investigational drugs, including vepdegestrant, ARV-393 for non-Hodgkin lymphoma, and ARV-102 for neurodegenerative disorders [6]

Core Insights - Arvinas, Inc. announced new preclinical combination data for ARV-393, which will be presented at the AACR Annual meeting, highlighting its potential to be combined with standard lymphoma treatments [1][2] Group 1: Product Information - ARV-393 is an investigational PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a key driver of B-cell lymphomas [2][4] - The degradation of BCL6 through PROTAC technology aims to address the traditionally undruggable nature of this protein, which plays a significant role in B cell tolerance and proliferation [4] Group 2: Presentation Details - The presentation of ARV-393 will take place on April 28, 2025, at the AACR Annual meeting, with the poster titled "ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma Models" [3] - The session will focus on experimental and molecular therapeutics, specifically under the title "Degraders and Glues 2" [3] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize the body's natural protein disposal system to selectively degrade disease-causing proteins [5] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer, ARV-393 for non-Hodgkin lymphoma, and ARV-102 for neurodegenerative disorders [5]

Arvinas, Inc. (ARVN) has been on a downward spiral lately with significant selling pressure. After declining 25.4% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a s ...

Arvinas, Inc. ARVN unveiled first-in-human data on Friday for its experimental Parkinson’s disease treatment, ARV-102.Results from the randomized, double-blind, placebo-controlled single ascending dose (SAD) cohort of the Phase 1 healthy volunteer trial and initial results from the multiple ascending dose (MAD) cohort were shared in a presentation at the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases.The Phase 1 trial included SAD cohorts from 10 mg to 200 mg and MAD cohorts of 10 mg ...

Core Insights - Arvinas, Inc. presented data from the first-in-human clinical trial of ARV-102, demonstrating its potential in reducing LRRK2 protein associated with neurodegenerative diseases like Parkinson's disease and progressive supranuclear palsy [1][3][7] Group 1: Clinical Trial Findings - ARV-102 was well tolerated and showed substantial LRRK2 reduction in both central and peripheral systems, indicating effective protein degradation [1][5] - The Phase 1 trial included a single ascending dose (SAD) cohort with doses from 10 mg to 200 mg and a multiple ascending dose (MAD) cohort with doses from 10 mg to 80 mg [2][3] - At doses of 60 mg or higher, ARV-102 achieved over 50% LRRK2 reduction in cerebrospinal fluid (CSF) and over 90% reduction in peripheral blood mononuclear cells (PBMCs) [5][9] Group 2: Safety and Tolerability - No serious adverse events were reported, and the drug was generally safe and well tolerated among healthy volunteers [4][5] - Common treatment-related adverse events included headache (17.1%) and fatigue (8.6%), with procedural pain from lumbar puncture reported in 28.6% of treated individuals [9] Group 3: Pharmacokinetics and Pharmacodynamics - ARV-102 demonstrated dose-dependent increases in exposure in both plasma and CSF, with a median terminal plasma half-life of 73 hours [9] - The drug's pharmacodynamic effects included significant reductions in phospho-Rab10T73 and bis(monoacylglycerol)phosphate (BMP) in urine, indicating engagement with downstream LRRK2 pathways [5][9] Group 4: Future Directions - Arvinas plans to continue the clinical program for ARV-102, with ongoing trials in patients with Parkinson's disease and expectations to present initial data in 2025 [7][10]