Arvinas LLC(ARVN)

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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Arvinas, Inc. - ARVN
GlobeNewswire News Room· 2025-05-05 16:09
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Group 1: Company Developments - On May 1, 2025, Arvinas announced the removal of plans for a Phase 3 first-line combination trial with atirmociclib and a second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [3] - The decision to remove these trials was based on a review of emerging information, external data results, the evolving treatment landscape in metastatic breast cancer, and long-term capital allocation [3] - Arvinas also announced a workforce reduction of approximately one-third to streamline operations and enable efficient progression of its portfolio, with completion planned for the second quarter of 2025 [3] - Following this news, Arvinas's stock price fell by $2.39 per share, or 24.84%, closing at $7.23 per share on May 1, 2025 [3]
Arvinas: Yet Another Biotech Trading Below Net Cash, But It's Only A Mild Bull Case
Seeking Alpha· 2025-05-04 20:17
Group 1 - The article discusses the strategy of investing in biotech stocks that have significantly declined in value following negative news, suggesting that such stocks may present buying opportunities [1] - The author has a background in Corporate Finance and has transitioned to full-time investment analysis, focusing on Canadian small cap stocks [1] - The author expresses a desire to engage in freelance opportunities related to Canadian or American listed stocks, indicating a commitment to high-quality analysis [1] Group 2 - There is a disclosure stating that the author does not currently hold any positions in the mentioned companies but may consider initiating a long position in ARVN within the next 72 hours [2] - The article emphasizes that past performance does not guarantee future results and that no specific investment recommendations are being made [3]
BREAKING: Block & Leviton Investigating Arvinas, Inc. (ARVN) For Securities Fraud After Shares Fall Over 20%; Investors Encouraged to Contact the Firm to Potentially Recover Losses
GlobeNewswire News Room· 2025-05-01 21:44
Core Viewpoint - Arvinas, Inc. shares dropped over 20% following the announcement of the discontinuation of vepdegestrant development, raising concerns about the company's transparency and management decisions [2]. Group 1: Company Developments - Arvinas, Inc. and Pfizer have decided to halt the development of vepdegestrant, an oral SERD for HR-positive breast cancer, which has led to the cancellation of two planned Phase 3 studies [2]. - The termination of the drug's development follows the earlier discontinuation of the VERITAC-3 study in January [2]. - Oppenheimer & Co. expressed surprise at the announcement and questioned the completeness of information provided by Arvinas' management [2]. Group 2: Investor Impact - Investors who have experienced losses in their Arvinas, Inc. investments are encouraged to contact Block & Leviton for potential recovery options [1][3]. - The investigation by Block & Leviton focuses on possible securities law violations by Arvinas, which may affect investor confidence and future stock performance [4]. Group 3: Legal and Recovery Options - Block & Leviton is a prominent securities class action firm that has successfully recovered billions for defrauded investors and is now investigating Arvinas [7]. - Investors with non-public information about Arvinas are encouraged to assist in the investigation or report to the SEC under the whistleblower program, which offers rewards for original information [6].
Arvinas LLC(ARVN) - 2025 Q1 - Quarterly Report
2025-05-01 21:16
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) Q1 Earnings and Revenues Beat Estimates
ZACKS· 2025-05-01 13:15
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 LLC(ARVN) - 2025 Q1 - Earnings Call Transcript
2025-05-01 13:02
Arvinas (ARVN) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Company Participants Jeff Boyle - Vice President of Investor RelationsJohn Houston - Chairperson, CEO & PresidentNoah Berkowitz - Chief Medical OfficerAndrew Saik - CFO & TreasurerAndrew Berens - Senior Managing Director, Targeted OncologyManoj Eradath - Senior Biotechnology Equity ResearcherJonathan Miller - Managing DirectorTazeen Ahmad - MD - US Equity ResearchYigal Nochomovitz - DirectorMalcolm Hoffman - Senior BioPharma Equity Research Assoc ...
Arvinas LLC(ARVN) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
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 ...
Arvinas LLC(ARVN) - 2025 Q1 - Quarterly Results
2025-05-01 11:05
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 ...
Arvinas Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire· 2025-05-01 11:00
– 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 ...
Arvinas to Report First Quarter 2025 Financial Results on Thursday, May 1, 2025
GlobeNewswire News Room· 2025-04-28 11:00
NEW HAVEN, Conn., April 28, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical- stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today announced that management will review first quarter 2025 financial results and provide a corporate update during a live webcast on Thursday, May 1, 2025, at 8:00 a.m. ET. The webcast can be accessed under "Events and Presentations" on the investor page of the Arvinas website. A replay of the webcast wil ...