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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
Financial Data and Key Metrics Changes - The company reported revenue of $188.8 million for Q1 2025, a significant increase from $25.3 million in Q1 2024, primarily due to changes in collaboration agreements [32] - Cash, cash equivalents, and marketable securities decreased to approximately $954 million at the end of Q1 2025 from $1.04 billion at the end of 2024 [32] - The restructuring is expected to reduce ongoing infrastructure costs by approximately $80 million annually, with full savings realized by Q4 2025 [30][31] Business Line Data and Key Metrics Changes - The company is advancing its pipeline with positive pivotal data for the protact degrader vebbegastran, which is expected to be filed for registration soon [5][8] - The company has removed two Phase III combination trials from its development plan, which is anticipated to result in cost avoidance of approximately $350 million to $400 million over the next three to five years [30][31] Market Data and Key Metrics Changes - The company estimates that there are approximately 40,000 new patients in the second-line setting annually, with 40% being ESR1 mutant only, representing a significant market opportunity for vebbegastran [57][58] - The company believes that vebbegastran has the potential to capture a significant portion of the market due to its profile as a degrader [58] Company Strategy and Development Direction - The company is focusing on maximizing efficiency and reducing operating expenses, including a workforce reduction of approximately one-third of the company [11][12] - The company aims to extend its cash runway into the second half of 2028 while prioritizing clinical programs that have the greatest potential for value [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of vebbegastran as a best-in-class treatment for patients with ESR1 mutant breast cancer [8][17] - The company is optimistic about its early development programs and the potential for significant data inflection points in 2025 [35] Other Important Information - The company has received a safe to proceed letter from the FDA for its KRAS G12D degrader, ARV-806, and anticipates beginning a Phase I trial in patients with solid tumors in the second half of the year [26][27] - The company is also exploring additional targets relevant for Huntington's and Alzheimer's disease in its discovery portfolio [22] Q&A Session Summary Question: What drove the decision to not advance the four-six inhibitor combinations? - The decision was based on discussions with Pfizer regarding the emerging data indicating that ER therapies would likely be restricted to patients with ESR1 mutations in the second-line plus setting [41][42] Question: How do you view the market size of vebbegastran in the second-line plus monotherapy setting? - The company estimates a significant opportunity with approximately 25,000 new patients annually in the second-line setting, with a good profile for vebbegastran to capture a substantial market share [57][58] Question: What is the expected timeline for market entry for vebbegastran? - The company is on track to submit a regulatory filing with health authorities in the coming months, with commercial plans being data-driven [8][43] Question: What can be expected from the LRRK2 program in Parkinson's disease? - The company anticipates providing updates on pharmacokinetics, pharmacodynamics, safety, and tolerability from the Phase I single ascending dose cohort later in the year [22][70]
Arvinas LLC(ARVN) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $188.8 million, a significant increase from $25.3 million in Q1 2024, primarily due to accounting impacts from the reduction in the BebteG collaboration agreements program budget [30][31] - Cash, cash equivalents, and marketable securities at the end of Q1 2025 were approximately $954 million, down from $1.04 billion at the end of 2024 [30] Business Line Data and Key Metrics Changes - The company has made progress in its clinical pipeline, including positive pivotal data for the protact degrader Vebbegastran and advancements in other programs such as ARV-102 and ARV-393 [4][5][14] - A workforce reduction of approximately one-third of the company was implemented, expected to result in annual cost reductions of about $80 million [10][11] Market Data and Key Metrics Changes - The second line plus setting for ESR1 mutant breast cancer presents a significant opportunity, with an estimated 40,000 new patients annually, of which 40% are expected to be ESR1 mutant [56][92] - The company anticipates that Vebbegastran could capture a significant portion of the market due to its best-in-class profile [41][56] Company Strategy and Development Direction - The company is focusing on maximizing efficiency and reducing operating expenses to extend its cash runway into the second half of 2028 [11][12] - The decision to remove two Phase III combination trials from the development plan was made in alignment with Pfizer, based on emerging data and discussions with health authorities [7][8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Vebbegastran as a best-in-class treatment for ESR1 mutant breast cancer and plans to submit a regulatory filing in the coming months [6][15] - The company is optimistic about the ongoing clinical programs and the potential for significant data inflection points in 2025 [34] Other Important Information - The company has received a safe to proceed letter from the FDA for ARV-806, its KRAS G12D degrader, with plans to begin a Phase I trial in the second half of 2025 [25][26] - The restructuring is expected to result in a total of approximately $500 million in cost savings and avoidance over the next three years [11][29] Q&A Session Summary Question: What drove the decision to not advance the four-six inhibitor combinations? - The decision was based on discussions with Pfizer and emerging data indicating that ER therapies would likely be restricted to patients with ESR1 mutations in the second line plus setting [40][41] Question: How do you view the market size for Vebdeg in the second line plus monotherapy setting? - The company estimates a significant opportunity with around 25,000 new patients annually in the second line setting, with a good profile for Vebdeg to capture a substantial market share [56][92] Question: What is the expected timeline for the pre NDA meeting with the FDA? - The company has already met with the FDA for the pre NDA meeting and is clear to move forward with the submission [109] Question: When can we expect the next data update from the LRRK2 program? - The company expects to share information later in the year, with ongoing studies in patients with Parkinson's disease [109]
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
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]
Arvinas to Report First Quarter 2025 Financial Results on Thursday, May 1, 2025
GlobeNewswire News Room· 2025-04-28 11:00
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]
Arvinas Shares New Preclinical Combination Data for the PROTAC BCL6 Degrader, ARV-393, at the 2025 American Association for Cancer Research Annual Meeting
Globenewswire· 2025-04-28 10:45
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]
Arvinas Announces Results from the VERITAC-2 Trial Selected as Late-Breaking Oral Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-04-23 14:44
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]