Arvinas LLC(ARVN)

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Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
Globenewswire· 2025-08-08 20:05
Core Viewpoint - The FDA has accepted the New Drug Application (NDA) for vepdegestrant, a novel treatment for advanced or metastatic breast cancer, with a PDUFA action date set for June 5, 2026 [1][5]. Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing therapies for life-threatening diseases using its PROTAC protein degrader platform [8]. - The company is collaborating with Pfizer for the co-development and commercialization of vepdegestrant, sharing development costs and profits [4]. Product Details - Vepdegestrant is an investigational oral PROTAC estrogen receptor degrader aimed at treating ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations [3][5]. - The drug has shown statistically significant improvement in median progression-free survival compared to fulvestrant in the Phase 3 VERITAC-2 clinical trial [1][2]. Clinical Trial Information - The VERITAC-2 trial enrolled 624 patients across 213 sites in 25 countries, with 270 patients having ESR1 mutations [6][7]. - The primary endpoint of the trial was progression-free survival, with overall survival as a key secondary endpoint [7]. Regulatory Status - Vepdegestrant has been granted Fast Track designation by the FDA, highlighting the unmet medical need in the target patient population [5].
Arvinas LLC(ARVN) - 2025 Q2 - Quarterly Report
2025-08-06 21:17
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents the unaudited condensed consolidated financial statements and management's discussion for the six months ended June 30, 2025 [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents unaudited condensed consolidated financial statements for H1 2025, showing a net income turnaround and shifts in assets and equity [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$909.3 million** from **$1,091.4 million** at year-end 2024, while equity increased to **$609.3 million** Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $114.9 | $100.5 | | Marketable securities | $746.3 | $938.9 | | Total current assets | $889.5 | $1,067.3 | | **Total assets** | **$909.3** | **$1,091.4** | | **Liabilities & Equity** | | | | Deferred revenue (Current & Long-term) | $237.0 | $448.2 | | Total liabilities | $300.0 | $529.7 | | Total stockholders' equity | $609.3 | $561.7 | | **Total liabilities and stockholders' equity** | **$909.3** | **$1,091.4** | [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20%28Loss%29%20Income) Reports **$21.7 million** net income for H1 2025, a significant improvement from a **$104.6 million** net loss in H1 2024 Consolidated Statements of Operations Highlights (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $22.4 | $76.5 | $211.2 | $101.8 | | Research and development | $68.6 | $93.7 | $159.4 | $178.0 | | General and administrative | $25.3 | $31.3 | $51.9 | $55.6 | | Loss from operations | $(71.5) | $(48.5) | $(0.1) | $(131.8) | | Net (loss) income | $(61.2) | $(35.2) | $21.7 | $(104.6) | | Diluted (Loss) earnings per share | $(0.84) | $(0.49) | $0.30 | $(1.46) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$184.3 million** in H1 2025, offset by **$198.3 million** from investing activities Cash Flow Summary for the Six Months Ended June 30 (in millions) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(184.3) | $(47.2) | | Net cash provided by (used in) investing activities | $198.3 | $(114.7) | | Net cash provided by financing activities | $0.4 | $5.0 | | Net increase (decrease) in cash | $14.4 | $(156.9) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details accounting policy changes, collaboration impacts, and a Q2 2025 restructuring plan reducing workforce by **33%** - A change in accounting estimate for the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, due to removing two Phase 3 trials from the development plan, resulted in a **$147.6 million** increase in net income for the six months ended June 30, 2025[53](index=53&type=chunk) - In Q2 2025, the company implemented a restructuring plan, reducing its workforce by approximately **33%**, resulting in a net charge of **$1.0 million**, comprising **$7.4 million** in cash severance offset by a **$6.4 million** reversal of non-cash stock compensation and bonus expenses[97](index=97&type=chunk)[98](index=98&type=chunk) R&D Expenses by Program (in millions) | Program | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Vepdegestrant (ARV-471) | $15.1 | $25.1 | $39.2 | $44.1 | | ARV-102 | $3.8 | $1.7 | $10.3 | $3.0 | | ARV-393 | $2.5 | $1.7 | $5.1 | $2.9 | | ARV-806 | $1.7 | $0.2 | $2.6 | $0.3 | | Luxdegalutamide (ARV-766) | $0.0 | $9.5 | $0.0 | $13.2 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses business strategy, clinical pipeline progress, financial results, and liquidity, projecting capital sufficiency into H2 2028 [Business Overview](index=25&type=section&id=Business%20Overview) Arvinas, a clinical-stage biotech, submitted an NDA for vepdegestrant and initiated a Phase 1 trial for ARV-806, alongside a **33%** workforce reduction - Submitted a New Drug Application (NDA) to the FDA for vepdegestrant in Q2 2025 for ER+/HER2- ESR1-mutated advanced or metastatic breast cancer, representing the first NDA for a PROTAC[118](index=118&type=chunk) - The Phase 3 VERITAC-2 trial for vepdegestrant met its primary endpoint, showing a **43%** reduction in the risk of disease progression or death compared to fulvestrant in the ESR1m patient population[122](index=122&type=chunk) - The company is in active discussions with Pfizer to revise the vepdegestrant collaboration after removing two planned Phase 3 combination trials from the joint development plan and determining it is no longer viable to build out its own commercial infrastructure[124](index=124&type=chunk)[127](index=127&type=chunk) - A Phase 1 trial for ARV-806 (KRAS G12D degrader) was initiated in Q2 2025 for patients with solid tumors harboring KRAS G12D mutations[147](index=147&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Revenue increased by **$109.4 million** to **$211.2 million** in H1 2025, resulting in **$21.7 million** net income, driven by a Pfizer collaboration accounting change Comparison of Results of Operations (in millions) | Line Item | Six Months 2025 | Six Months 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Revenue | $211.2 | $101.8 | $109.4 | | Research and development expenses | $(159.4) | $(178.0) | $18.6 | | General and administrative expenses | $(51.9) | $(55.6) | $3.7 | | Net income (loss) | $21.7 | $(104.6) | $126.3 | - The **$109.4 million** increase in revenue for H1 2025 was primarily driven by a **$161.0 million** increase from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer due to changes in total program cost estimates[201](index=201&type=chunk) - The **$18.6 million** decrease in R&D expenses for H1 2025 was mainly due to reduced external expenses for the luxdegalutamide (ARV-766) and vepdegestrant (ARV-471) programs, and lower compensation costs[204](index=204&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$861.2 million** in cash and marketable securities, projected to fund operations into the second half of 2028 - The company's cash, cash equivalents, and marketable securities totaled **$861.2 million** as of June 30, 2025[219](index=219&type=chunk)[225](index=225&type=chunk) - Management projects that the current cash position will fund planned operating expenses and capital expenditure requirements into the second half of 2028[225](index=225&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2025, was **$184.3 million**, an increase of **$137.1 million** from the same period in 2024, primarily due to a decrease in deferred revenue[219](index=219&type=chunk)[220](index=220&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on cash and marketable securities, with **$22.0 million** interest income in H1 2025 - The company's main market risk is interest rate sensitivity on its portfolio of cash, cash equivalents, and marketable securities, with interest income for the first six months of 2025 at **$22.0 million**[233](index=233&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[234](index=234&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[235](index=235&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) Provides updates on legal proceedings, new and amended risk factors, and other corporate information [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[238](index=238&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Introduces new risks regarding workforce reduction and regulatory delays, while amending existing risks on funding and key personnel retention - A new risk factor was added concerning the April 2025 workforce reduction of approximately **33%**, which may not result in anticipated savings and could disrupt operations or harm the ability to attract and retain talent[240](index=240&type=chunk) - A new risk factor highlights potential disruptions at the FDA and other government agencies due to funding cuts, personnel losses (RIF), and government shutdowns, which could hinder the ability to secure timely approval for product candidates[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - An amended risk factor underscores that future success depends on retaining key employees and managing the transition to a new CEO, following the announced retirement of the current President and CEO[264](index=264&type=chunk)[265](index=265&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not issue any unregistered equity securities during the second quarter of 2025 - There were no sales of unregistered equity securities during the second quarter of 2025[274](index=274&type=chunk) [Other Information](index=53&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q2 2025 - No director or officer trading arrangements under Rule 10b5-1 were adopted or terminated during the quarter[275](index=275&type=chunk) [Exhibits](index=54&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including corporate governance documents and certifications
Arvinas, Inc. (ARVN) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-06 13:15
Company Performance - Arvinas, Inc. reported a quarterly loss of $0.84 per share, which was better than the Zacks Consensus Estimate of a loss of $0.87, but worse than a loss of $0.49 per share a year ago, indicating an earnings surprise of +3.45% [1] - The company posted revenues of $22.4 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 53.28%, and a significant decline from year-ago revenues of $76.5 million [2] - Over the last four quarters, Arvinas has surpassed consensus EPS estimates four times and topped consensus revenue estimates two times [2] Stock Outlook - Arvinas shares have declined approximately 60.3% since the beginning of the year, contrasting with the S&P 500's gain of 7.1% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.75 on revenues of $41.04 million, and for the current fiscal year, it is -$1.50 on revenues of $294.99 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Arvinas belongs, is currently ranked in the bottom 42% of over 250 Zacks industries, suggesting that the industry outlook may negatively impact stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]
Arvinas LLC(ARVN) - 2025 Q2 - Earnings Call Transcript
2025-08-06 13:00
Financial Data and Key Metrics Changes - The company reported a revenue of $22.4 million for the second quarter of 2025, a decrease of $54.1 million compared to $76.5 million in the same period of 2024, primarily due to reduced revenue from the Novartis license agreement and the VetDeg collaboration with Pfizer [31][32] - Cash, cash equivalents, and marketable securities at the end of the second quarter were approximately $861.2 million, down from $1.04 billion as of December 31, 2024 [31] - General and administrative expenses decreased to $25.3 million from $31.3 million year-over-year, while research and development expenses fell to $68.6 million from $93.7 million [32] Business Line Data and Key Metrics Changes - The company is focusing on three Phase I trials in its neuro and oncology portfolio, including the recently initiated trial with the KRAS G12D degrader, ARV-806 [3][4] - Significant clinical progress was made with ARV-102, the LAR2 degrader, and ARV-393, the BCL6 degrader, with compelling preclinical data supporting their advancement [4][21] - The restructuring included a reprioritization of the research pipeline, cutting several programs while continuing investment in high-potential assets [5][28] Market Data and Key Metrics Changes - The collaboration with Pfizer for VetDeg is being reworked due to the removal of combination pivotal trials, which has led to a reassessment of the co-commercialization agreement [10][30] - The company is actively seeking a new partner for VetDeg should negotiations with Pfizer not yield favorable terms [10][30] Company Strategy and Development Direction - The company aims to advance VetDeg towards commercial launch, achieve critical data milestones from its pipeline, and allocate capital efficiently [9][35] - The long-term strategy includes focusing on differentiated PROTAC technology in both neuroscience and oncology, with an emphasis on maximizing shareholder value [11][28] - The company is conducting a CEO search process to ensure leadership continuity and strategic direction [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and the potential of its clinical pipeline to drive future value [11][28] - The company anticipates multiple near-term milestones across its clinical development and regulatory efforts, including potential approval of a PROTAC [34][35] - Management highlighted the importance of achieving critical data milestones in the next twelve months to support the company's growth trajectory [11][35] Other Important Information - The company has extended its cash runway into 2028 following the restructuring and cost-reduction measures [28][33] - The NDA for VetDeg has been submitted, marking a significant milestone as the first PROTAC degrader to enter clinical trials and submit for approval [19][31] Q&A Session Summary Question: Can you provide more details on the expected data from ARV-102 this year? - Management indicated that they expect to present data from healthy volunteers and initial data from Parkinson's patients in upcoming conferences [40][41] Question: What are the expectations for the BCL6 program and potential combination therapies? - Management emphasized the importance of establishing a monotherapy dose before exploring combination therapies, particularly with bispecifics in DLBCL [51][52] Question: How does the company plan to handle the potential return of VetDeg rights from Pfizer? - The company is negotiating with Pfizer to rework the collaboration and is prepared to seek a new partner if necessary, aiming to minimize any gaps in commercialization [68][70] Question: What is the company's outlook on the recent Phase III trial results in breast cancer? - Management stated that the results would have little impact on their modeling and confirmed they would not pursue further development with the drug in question [77][78] Question: Can you comment on the interactions with the FDA regarding the NDA submission? - Management reported that interactions with the FDA have been smooth and timely, with no current delays affecting their submission process [94][96]
Arvinas LLC(ARVN) - 2025 Q2 - Quarterly Results
2025-08-06 11:03
[Business Highlights and Recent Developments](index=1&type=section&id=Business%20Highlights%20and%20Recent%20Developments) Arvinas reported significant progress across its PROTAC degrader pipeline, highlighted by a vepdegestrant NDA submission and advancements in other clinical programs - Submitted a New Drug Application (NDA) to the U.S. FDA for vepdegestrant, marking the first-ever NDA submission for a PROTAC degrader[1](index=1&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - Presented positive first-in-human data for ARV-102, a LRRK2 degrader, from a Phase 1 trial in healthy volunteers, and initiated dosing in patients with Parkinson's disease[1](index=1&type=chunk)[3](index=3&type=chunk)[8](index=8&type=chunk) - Initiated a Phase 1 clinical trial for ARV-806, a novel degrader targeting KRAS G12D mutations in patients with solid tumors[1](index=1&type=chunk)[10](index=10&type=chunk) [Vepdegestrant: Oral PROTAC ER degrader](index=1&type=section&id=Vepdegestrant:%20Oral%20PROTAC%20ER%20degrader) Vepdegestrant's NDA submission for breast cancer is supported by a 2.9-month PFS improvement in ESR1 mutation patients, but lacked overall statistical significance - Submitted a New Drug Application to the U.S. FDA for vepdegestrant[4](index=4&type=chunk) - The pivotal Phase 3 VERITAC-2 trial demonstrated a **2.9-month improvement in median PFS** versus fulvestrant in patients with an ESR1 mutation[4](index=4&type=chunk) - The VERITAC-2 trial did not meet statistical significance for PFS improvement in the overall intent-to-treat (ITT) population[4](index=4&type=chunk) - A new combination cohort of vepdegestrant plus Pfizer's KAT6 inhibitor (PF-07248144) was added to an ongoing Phase 1 trial[4](index=4&type=chunk)[5](index=5&type=chunk) [ARV-102: Oral PROTAC LRRK2 degrader](index=3&type=section&id=ARV-102:%20Oral%20PROTAC%20LRRK2%20degrader) ARV-102 Phase 1 data showed brain penetration and significant LRRK2 degradation in CSF and PBMCs, with good tolerability - Achieved **>50% LRRK2 reduction in CSF** and **>90% in PBMCs** at specific dose levels, indicating substantial central and peripheral protein degradation[8](index=8&type=chunk) - ARV-102 was shown to be bioavailable, brain-penetrant, and generally safe and well-tolerated with no serious adverse events reported in healthy volunteers[8](index=8&type=chunk) - Completed enrollment in the single ascending dose (SAD) cohort of the Phase 1 trial in patients with Parkinson's disease[8](index=8&type=chunk) [ARV-393: Oral PROTAC BCL6 degrader](index=3&type=section&id=ARV-393:%20Oral%20PROTAC%20BCL6%20degrader) ARV-393 preclinical data showed significant single-agent activity and combinability in lymphoma models, with a Phase 1 NHL trial actively recruiting - Preclinical data presented at AACR and EHA showed ARV-393 has broad combinability with other cancer therapies and significant single-agent activity in lymphoma models[8](index=8&type=chunk) - Data suggests ARV-393 could be a key component in chemo-free or all-oral combination treatments for lymphoma[9](index=9&type=chunk) - Recruitment is ongoing for the first-in-human Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL)[8](index=8&type=chunk) [ARV-806: Novel PROTAC KRAS G12D degrader](index=5&type=section&id=ARV-806:%20Novel%20PROTAC%20KRAS%20G12D%20degrader) Arvinas initiated enrollment in the Phase 1 clinical trial for ARV-806, targeting KRAS G12D mutations in solid tumors - Initiated enrollment in the Phase 1 clinical trial for ARV-806 in patients with solid tumors harboring KRAS G12D mutations[10](index=10&type=chunk) [Corporate Updates and Upcoming Milestones](index=5&type=section&id=Corporate%20Updates%20and%20Upcoming%20Milestones) Arvinas announced CEO John Houston's planned retirement and outlined key upcoming milestones for vepdegestrant, ARV-102, and ARV-393 - CEO John Houston announced his plan to retire following the appointment of a successor; he will remain Chairperson of the Board[14](index=14&type=chunk) - Multiple key data readouts are expected in the second half of 2025, including initial patient data for ARV-102 and ARV-393[14](index=14&type=chunk)[20](index=20&type=chunk) [Vepdegestrant Milestones](index=5&type=section&id=Vepdegestrant%20Milestones) Upcoming vepdegestrant milestones include PDUFA action date preparation and VERITAC-2 and TACTIVE-N data presentation at ESMO 2025 - Continue market preparations in advance of the PDUFA action date[14](index=14&type=chunk) - Present patient-reported outcomes from VERITAC-2 and results from the TACTIVE-N neoadjuvant trial at ESMO in October 2025[14](index=14&type=chunk) [ARV-102 Milestones](index=5&type=section&id=ARV-102%20Milestones) ARV-102 milestones include sharing initial Parkinson's patient data in 2H 2025 and initiating a Phase 1b trial in progressive supranuclear palsy in 1H 2026 - Share initial data from the SAD cohort in Parkinson's disease patients in 2H 2025[14](index=14&type=chunk) - Initiate a Phase 1b clinical trial in patients with progressive supranuclear palsy in 1H 2026[14](index=14&type=chunk) [ARV-393 Milestones](index=5&type=section&id=ARV-393%20Milestones) ARV-393 milestones include sharing preclinical combination data and preliminary clinical data from the ongoing Phase 1 NHL trial in 2H 2025 - Share preliminary clinical data from the ongoing Phase 1 trial in patients with NHL in 2H 2025[20](index=20&type=chunk) [ARV-806 Milestones](index=6&type=section&id=ARV-806%20Milestones) ARV-806 milestones include continued Phase 1 trial enrollment for KRAS G12D-mutated solid tumors and sharing preclinical data in 2H 2025 - Continue enrollment in the Phase 1 trial and share preclinical data from the program in 2H 2025[20](index=20&type=chunk) [Financial Performance](index=6&type=section&id=Financial%20Performance) Arvinas ended Q2 2025 with $861.2 million in cash, projecting funding into 2H 2028, with decreased revenue and a net loss [Financial Guidance](index=6&type=section&id=Financial%20Guidance) Arvinas projects its $861.2 million cash, cash equivalents, and marketable securities will fund operations into the second half of 2028 - The company's cash position is expected to fund operations into the second half of 2028[15](index=15&type=chunk) [Second Quarter Financial Results](index=6&type=section&id=Second%20Quarter%20Financial%20Results) Q2 2025 revenue decreased to $22.4 million, with reduced R&D and G&A expenses, and a $178.2 million cash decrease Q2 2025 Key Financial Metrics (GAAP) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | $22.4M | $76.5M | -70.7% | | R&D Expenses | $68.6M | $93.7M | -26.8% | | G&A Expenses | $25.3M | $31.3M | -19.2% | | Net Loss | ($61.2M) | ($35.2M) | +73.9% | | Loss Per Share | ($0.84) | ($0.49) | +71.4% | - The decrease in revenue was primarily due to a **$45.6 million reduction** from the completed Novartis agreements and a **$6.8 million decrease** from the Pfizer collaboration[22](index=22&type=chunk) - The decrease in R&D expenses was driven by reduced spending on the vepdegestrant and luxdegalutamide programs[17](index=17&type=chunk) Cash Position | Date | Cash, Cash Equivalents, and Marketable Securities | | :--- | :--- | | June 30, 2025 | $861.2 million | | Dec 31, 2024 | $1,039.4 million | [Financial Statements](index=10&type=section&id=Financial%20Statements) The condensed consolidated balance sheet shows total assets of $909.3 million and liabilities of $300.0 million, with a net loss of $61.2 million Condensed Consolidated Balance Sheet (Unaudited) | (in millions) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $114.9 | $100.5 | | Marketable securities | $746.3 | $938.9 | | Total current assets | $889.5 | $1,067.3 | | **Total assets** | **$909.3** | **$1,091.4** | | **Liabilities & Equity** | | | | Total current liabilities | $157.8 | $229.8 | | **Total liabilities** | **$300.0** | **$529.7** | | **Total stockholders' equity** | **$609.3** | **$561.7** | Condensed Consolidated Statements of Operations (Unaudited) | For the Three Months Ended June 30, (in millions) | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $22.4 | $76.5 | | Total operating expenses | $93.9 | $125.0 | | Loss from operations | ($71.5) | ($48.5) | | **Net (loss) income** | **($61.2)** | **($35.2)** | | **(Loss) earnings per common share - Basic & Diluted** | **($0.84)** | **($0.49)** |
Arvinas Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-06 11:00
– Presented ARV-102 SAD and MAD data from the Phase 1 clinical trial in healthy volunteers; initiated dosing in patients with Parkinson's disease – – Presented preclinical data from ARV-393 program demonstrating single-agent activity and favorable combinability profile – – Initiated Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations – – Company to host conference call today at 8:00 a.m. ET – NEW HAVEN, Conn., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. ...
Arvinas to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-30 20:05
NEW HAVEN, Conn., July 30, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that management will review financial results from the second quarter of 2025 and provide a corporate update during a live webcast on Wednesday, August 6, 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 webcas ...
Arvinas Announces Retirement of Chief Executive Officer and Succession Plan
GlobeNewswire News Room· 2025-07-09 11:00
Core Points - John Houston, Ph.D., plans to retire as CEO of Arvinas after a successor is appointed, but will remain as Chairperson of the Board [1][2] - The Board of Directors is actively searching for a new CEO to ensure continued strong leadership [2] - Dr. Houston has been pivotal in advancing Arvinas' PROTAC programs, including the first positive pivotal Phase 3 trial [3][4] Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing targeted protein degradation therapies [5] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer and ARV-393 for non-Hodgkin lymphoma [5]
Wall Street Analysts Believe Arvinas (ARVN) Could Rally 89.85%: Here's is How to Trade
ZACKS· 2025-06-16 14:56
Group 1 - Arvinas, Inc. (ARVN) shares have increased by 13.9% over the past four weeks, closing at $7.39, with a mean price target of $14.03 indicating a potential upside of 89.9% [1] - The mean estimate is based on 17 short-term price targets with a standard deviation of $4.54, where the lowest estimate is $8 (8.3% increase) and the highest is $24 (224.8% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements [11][12] Group 2 - The Zacks Consensus Estimate for ARVN has increased by 5.5% due to two upward revisions in earnings estimates over the last 30 days [12] - ARVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential upside [13] - While price targets are often viewed skeptically, the direction implied by the consensus price target suggests a positive outlook for ARVN [10][13]
Arvinas Presents Preclinical Data for PROTAC BCL6 Degrader, ARV-393, at the European Hematology Association 2025 Congress
Globenewswire· 2025-06-13 11:00
Core Insights - Arvinas, Inc. presented promising preclinical data for ARV-393, a PROTAC BCL6 degrader, showing significant single-agent activity in models of nodal T-follicular helper cell lymphoma and transformed follicular lymphoma, as well as enhanced antitumor activity in combination with small molecule inhibitors in aggressive diffuse large B-cell lymphoma models [1][2][3] Group 1: Preclinical Study Findings - ARV-393 demonstrated robust tumor growth inhibition (≥95%) in two patient-derived xenograft models of transformed follicular lymphoma [4] - In combination with five classes of small molecule inhibitors, ARV-393 showed increased tumor growth inhibition in cell line-derived xenograft models of high-grade B-cell lymphoma and aggressive diffuse large B-cell lymphoma compared to monotherapy [4] - RNA sequencing studies indicated that ARV-393 inhibits tumor cell cycle progression and promotes differentiation, contributing to its antitumor activity [4] Group 2: Clinical Development - A Phase 1 study of ARV-393 is currently enrolling adult patients with relapsed/refractory non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and nodal T-follicular helper cell lymphoma [2] - The company is exploring combination strategies, including chemotherapy-free approaches, to enhance treatment options for adult patients with lymphoma [2] 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 non-Hodgkin lymphoma [6] - The company is advancing multiple investigational drugs, including ARV-393 for BCL6, vepdegestrant for ER+/HER2- breast cancer, ARV-102 for neurodegenerative disorders, and ARV-806 for KRAS G12D mutated cancers [6]