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]

[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)** |

Core Insights - Arvinas, Inc. has made significant clinical and regulatory advancements, including the submission of a New Drug Application (NDA) for vepdegestrant, marking a milestone as the first PROTAC degrader to enter clinical trials and achieve a positive Phase 3 trial outcome [3][5] - The company reported a decrease in revenue for Q2 2025, primarily due to the completion of previous collaboration agreements, while maintaining a strong cash position to fund operations into the second half of 2028 [20][14] Clinical Developments - The NDA for vepdegestrant was submitted to the FDA for treating ESR1m, ER+/HER2- advanced or metastatic breast cancer, with pivotal trial results showing a 2.9-month improvement in median progression-free survival compared to fulvestrant [5][3] - Arvinas presented data from the Phase 1 clinical trial of ARV-102, demonstrating over 50% LRRK2 reduction in cerebrospinal fluid and over 90% reduction in peripheral blood mononuclear cells [10][6] - The company initiated a Phase 1 clinical trial for ARV-806 targeting KRAS G12D mutations in solid tumors [8][3] Financial Performance - For Q2 2025, Arvinas reported revenue of $22.4 million, a decrease from $76.5 million in Q2 2024, attributed to reduced collaboration revenue from Novartis and other agreements [20][14] - Research and development expenses were $68.6 million for the quarter, down from $93.7 million in the same period last year, reflecting a decrease in external expenses and personnel costs [15][14] - The company ended Q2 2025 with cash, cash equivalents, and marketable securities totaling $861.2 million, down from $1,039.4 million at the end of 2024 [14][20] Corporate Updates - John Houston, CEO and President of Arvinas, announced plans to retire, with the Board of Directors beginning a search for a new CEO while he will remain as Chairperson [11] - The company is preparing for upcoming milestones, including presenting patient-reported outcomes data from the VERITAC-2 trial at the European Society for Medical Oncology Congress in October 2025 [16][9]

Core Insights - Arvinas, Inc. is set to review its financial results for Q2 2025 and provide a corporate update on August 6, 2025 [1] - The company specializes in targeted protein degradation therapies through its PROTAC platform, aiming to treat various life-threatening diseases [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing drugs that utilize the body's natural protein disposal system to eliminate disease-causing proteins [3] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer, ARV-393 for non-Hodgkin Lymphoma, ARV-102 for neurodegenerative disorders, and ARV-806 for KRAS G12D mutated cancers [3] Upcoming Events - A live webcast for the financial results and corporate update will be accessible on the Arvinas investor page, with a replay available post-event [2]

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]

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]

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]

Group 1 - Arvinas and Pfizer submitted a New Drug Application (NDA) for Vepdegestrant, the first PROTAC drug to seek approval, targeting advanced or metastatic breast cancer patients with ESR1 mutations [1] - The approval of Vepdegestrant could fill a significant treatment gap in the breast cancer market, attracting substantial investment and enhancing the overall industry valuation [1] Group 2 - Beijing Tide Pharmaceutical's TDI01 has been proposed for inclusion as a breakthrough therapy for chronic graft-versus-host disease (cGVHD), indicating its potential in a complex treatment area [2] - TDI01 is a novel ROCK2 inhibitor, and its breakthrough designation could significantly enhance the company's valuation and attract investor interest, bolstering China's innovative drug competitiveness [2] Group 3 - Anke Biotech anticipates significant sales growth for its trastuzumab product, Ansaiting, projecting over 100 million yuan in revenue for 2024 [3] - The positive market performance of Ansaiting enhances Anke Biotech's position in the oncology sector, potentially attracting more investors and supporting future research and market expansion [3] Group 4 - Haiwang Bio announced the termination of its control change and stock issuance, indicating ongoing discussions with state-owned entities for potential equity cooperation [4] - The proactive approach to resource integration and business collaboration may create new growth opportunities for Haiwang Bio, positively influencing market perceptions of its long-term value [4] Group 5 - Green Valley Pharmaceutical has ceased production of its Alzheimer's drug, Ganluo Sodium Capsules, following concerns over its efficacy and safety [6] - The shutdown reflects significant operational adjustments for the company, potentially leading to investor concerns about its future prospects and market confidence [6]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [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 Phase 3 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]

Core Viewpoint - Arvinas, Inc. has submitted a New Drug Application (NDA) to the FDA for vepdegestrant, a potential treatment for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer, based on positive results from the Phase 3 VERITAC-2 clinical trial [1][2] Group 1: Clinical Trial Details - The VERITAC-2 trial is a global, randomized Phase 3 study evaluating the efficacy and safety of vepdegestrant compared to fulvestrant in 624 patients across 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy [3][4] - Patients in the trial were randomized 1:1 to receive either vepdegestrant or fulvestrant, with 43% of patients having ESR1 mutations detected [4] - The primary endpoint of the trial was progression-free survival (PFS) in both the ESR1-mutation and intent-to-treat populations, with overall survival as a key secondary endpoint [4] Group 2: Drug Development and Collaboration - Vepdegestrant is an investigational PROTAC protein degrader designed to target and degrade the estrogen receptor, being developed as a potential monotherapy for advanced or metastatic ER+/HER2- breast cancer with ESR1 mutations [5][6] - Arvinas and Pfizer have a global collaboration for the co-development and co-commercialization of vepdegestrant, sharing worldwide development costs, commercialization expenses, and profits [6] Group 3: Regulatory Status and Future Outlook - The FDA has granted vepdegestrant Fast Track designation as a monotherapy for the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy [6] - The results from the VERITAC-2 study were presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine, highlighting the significance of the findings [2]