BOSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Arvinas, Inc. (Nasdaq: ARVN) for potential securities law violations. Investors who have lost money in their Arvinas, Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/arvn. What is this all about? Shares of Arvinas fell over 20% in intraday trading today, after the company and its partner Pfizer announced they would discontinue devel ...

Clinical Trials and Drug Development - The Phase 3 VERITAC-2 clinical trial for vepdegestrant demonstrated a statistically significant improvement in progression-free survival (PFS) in the ESR1m population, exceeding the pre-specified target hazard ratio of 0.60[117] - The trial enrolled 624 patients across 26 countries, comparing vepdegestrant to fulvestrant, with the primary endpoint being PFS assessed by blinded independent central review[116] - ARV-393 is currently in a Phase 1 first-in-human clinical trial for relapsed/refractory non-Hodgkin lymphoma (NHL), with preliminary clinical data expected in the second half of 2025[122] - ARV-102 has shown substantial reduction of LRRK2 in cerebral spinal fluid, indicating promising safety and pharmacodynamic outcomes in its Phase 1 clinical trial[129] - The company plans to submit a new drug application for vepdegestrant to the U.S. FDA in the second half of 2025[115] - The collaboration with Pfizer for vepdegestrant includes ongoing clinical trials, with detailed results from the VERITAC-2 trial to be presented at the 2025 American Society of Clinical Oncology Annual Meeting[111] - ARV-393 demonstrated strong synergistic antitumor activity in preclinical models of aggressive diffuse large B-cell lymphoma when combined with standard of care chemotherapy[123] - The company is advancing ARV-806 into a first-in-human Phase 1 clinical trial targeting solid tumors with KRAS G12D mutations[104] - The company has filed an investigational new drug application for ARV-806 and expects to initiate a Phase 1 clinical trial in the second half of 2025[136] Financial Performance and Revenue - Revenue for Q1 2025 totaled $188.8 million, a significant increase of $163.5 million compared to $25.3 million in Q1 2024, primarily driven by the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer[188] - The net income for Q1 2025 was $82.9 million, a turnaround from a net loss of $69.4 million in Q1 2024, indicating improved financial performance[186] - The increase in revenue from the Vepdegestrant Collaboration Agreement was $167.8 million, offset by a decrease in revenue from other collaborations totaling $4.3 million[188] - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying instead on collaboration agreements and licensing arrangements[144] Expenses and Cost Management - Research and development expenses for Q1 2025 were $90.8 million, up from $84.3 million in Q1 2024, reflecting ongoing clinical trials and discovery efforts[186] - General and administrative expenses increased to $26.6 million in Q1 2025 from $24.3 million in Q1 2024, attributed to personnel management and compliance costs[186] - The company expects to incur approximately $10 million in costs related to a workforce reduction of approximately 33% to streamline operations[139] - The company anticipates continuing to incur significant operating losses for several years, dependent on successful product development and commercialization[140] Collaborations and Licensing Agreements - Under the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the company received a non-refundable upfront payment of $650 million and is eligible for up to $1.4 billion in contingent payments[146] - The Novartis Transaction resulted in a one-time upfront payment of $150 million, with potential additional payments of up to $1.01 billion based on milestones for luxdegalutamide (ARV-766)[156] - The company received an upfront non-refundable payment of $17.5 million under the Bayer Collaboration Agreement, with potential milestone payments totaling up to $688.0 million[161] - The Bayer Collaboration Agreement was terminated effective August 12, 2024, impacting future revenue streams[162] - Under the Restated Genentech Agreement, the company is eligible for milestone payments aggregating up to $44.0 million per target protein upon achieving specified development milestones[165] - Research and development expenses related to vepdegestrant are shared equally with Pfizer since July 22, 2021, indicating a collaborative approach to development costs[170] Cash Flow and Financial Position - Cash, cash equivalents, and marketable securities remained stable at $1.0 billion as of March 31, 2025, unchanged from December 31, 2024[199] - Net cash used in operating activities improved by $8.6 million to $(88.9) million in Q1 2025 from $(97.5) million in Q1 2024[200] - Net cash from investing activities increased by $197.3 million in Q1 2025, primarily due to a net increase in maturities of marketable securities[202] - The company anticipates significant future expenses as it continues clinical trials and product development, with cash resources expected to last into the second half of 2028[205] - The company has raised approximately $1.7 billion in gross proceeds from asset and equity sales since inception, with $913.0 million received from collaboration partners and licensing arrangements[198] Research and Development Insights - In preclinical models, ARV-102 was well tolerated, with headache reported in 17.1% and fatigue in 8.6% of treated individuals, compared to 0% and 25% in placebo controls respectively[134] - ARV-102 showed a dose-dependent increase in plasma concentration, with a median terminal plasma half-life of 73 hours, and achieved over 90% LRRK2 reduction in peripheral blood mononuclear cells at doses ≥60 mg[134] - Research and development expenses for Q1 2025 totaled $90.8 million, an increase of 7.7% from $84.3 million in Q1 2024, driven by a $7.8 million rise in external expenses[189] - Non-GAAP research and development expenses for Q1 2025 were $79.3 million, up from $71.9 million in Q1 2024, excluding non-cash stock-based compensation[190] - General and administrative expenses for Q1 2025 increased to $26.6 million from $24.3 million in Q1 2024, primarily due to a $2.4 million rise in professional fees[191] - Non-GAAP general and administrative expenses for Q1 2025 were $23.1 million, compared to $18.0 million in Q1 2024, excluding non-cash stock-based compensation[192] Interest Income and Debt - Interest income for the three months ended March 31, 2025, was $11.7 million, down from $14.0 million in the same period of 2024, indicating a decrease of approximately 16.4%[212] - As of March 31, 2025, the company's outstanding debt was $0.7 million, a slight decrease from $0.8 million as of December 31, 2024[212] - The company's interest-earning assets include cash, cash equivalents, and marketable securities, which are sensitive to changes in U.S. interest rates[212] - The fixed interest rate on the company's outstanding debt is 3.25% per annum[212]

Arvinas, Inc. (ARVN) came out with quarterly earnings of $1.14 per share, beating the Zacks Consensus Estimate of a loss of $0.86 per share. This compares to loss of $0.97 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 232.56%. A quarter ago, it was expected that this company would post a loss of $1.07 per share when it actually produced a loss of $0.63, delivering a surprise of 41.12%.Over the last four quarters, the company ...

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 ...

– 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 – – Announced the re-prioritization of its vepdegestrant development plan and research portfolio and initiated cost reductions, including a workforce reduction of approximately one-third, to extend the Company’s cash runway int ...

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]

– Oral presentation will serve as first presentation of detailed results from the Phase 3 VERITAC-2 clinical trial – NEW HAVEN, Conn., April 23, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that data from the global Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant versus fulvestrant in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer will be presented as a late-breaking ...

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 ...