[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]

Summary of Arvinas (ARVN) Conference Call Company Overview - Arvinas is focused on protein degradation and was founded in 2013 by Craig Kruse at Yale University, being the first company in this space [1][2] - The company has achieved several milestones, including being the first to obtain INDs, enter phase one and phase two trials, and complete pivotal trials with positive data for ProTAC technology [2][3] Core Technology and Benefits - Protein degradation technology allows for the elimination of targeted proteins through the cell's natural degradation system, offering advantages over traditional inhibitors [3][4] - ProTACs are catalytic, allowing for multiple rounds of degradation, and are orally bioavailable with broad tissue distribution [4][5] - The technology shows promise in oncology by overcoming resistance mechanisms and targeting previously undruggable targets [5][6] Current Portfolio and Collaborations - The primary focus is on Vebdegastrant (ER degrader) in partnership with Pfizer, with pivotal trial data recently presented at ASCO [7][9] - Other programs include ARV393 (BCL6 degrader), ARV102 (LARC2 degrader), and ARV806 (KRAS G12D degrader), with several in various stages of clinical trials [8][12] - The company has a strong capital position with nearly $1 billion in cash, providing a runway into the second half of 2028 [12] Clinical Data and Future Plans - Vebdegastrant showed a median progression-free survival (PFS) of 5 months in the ESR1 mutant group, outperforming fulvestrant by 2.9 months [9][10] - The NDA submission for Vebdegastrant is imminent, with plans for a potential launch in 2026 [11][12] - Upcoming data releases include results from the SCD cohort and initial phase one data for ARV393 and ARV806 [11][12] Strategic Considerations and Market Position - The partnership with Pfizer is under review, with discussions on potential changes to the collaboration structure due to evolving market conditions [13][14] - There is a belief that Vebdegastrant has opportunities in both second-line and first-line settings, although Pfizer has expressed hesitance to pursue first-line development [15][16] - The market for second-line treatments is estimated to be significantly larger than current figures, with potential sales for Vebdegastrant projected in the range of $500 million to $700 million [24][68] Investor Insights and Future Catalysts - The company is focused on balancing the potential of Vebdegastrant with other promising assets in its pipeline, including LARC2 and KRAS G12D [48][64] - Key inflection points for upcoming clinical data are expected by the end of 2026, with interim data available along the way [75][79] - The company aims to maintain a strong cash position while exploring strategic partnerships or licensing opportunities for its assets [52][84] Conclusion - Arvinas is positioned as a leader in the protein degradation space with a robust pipeline and strategic partnerships, while navigating challenges in collaboration and market dynamics. The upcoming clinical data and potential NDA submissions are critical for the company's future growth and investor confidence.