Core Insights - Arvinas, Inc. is advancing its clinical programs with a focus on vepdegestrant, a PROTAC protein degrader targeting ER+/HER2- breast cancer, with significant milestones expected in 2025 [1][10][11] Clinical Trials and Data - A Phase 3 trial combining vepdegestrant with Pfizer's CDK4 inhibitor atirmociclib is set to begin in 2025, alongside a second-line Phase 3 trial with a CDK4/6 inhibitor [1][3] - Topline data from the Phase 3 VERITAC-2 trial of vepdegestrant monotherapy is anticipated in the first quarter of 2025 [1][5] - Initial data from the Phase 1 trial of ARV-102, a PROTAC LRRK2 degrader for Parkinson's disease, is expected in the first half of 2025 [2][4] Corporate Developments - Alex Santini has been appointed interim Chief Commercial Officer effective January 17, 2025, bringing over 30 years of experience in commercial organizations [7] - John Northcott, the outgoing Chief Commercial Officer, is leaving the company for personal reasons, also effective January 17, 2025 [8][9] Future Plans - The company plans to file an Investigational New Drug (IND) application for a novel PROTAC KRAS G12D degrader in 2025 [6] - Data disclosures are anticipated from multiple clinical and pre-clinical programs, including ARV-102 and ARV-393 [1][2]

NEW HAVEN, Conn., Nov. 27, 2024 (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 Noah Berkowitz, M.D., Ph.D., Chief Medical Officer and Andrew Saik, Chief Financial Officer will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3 at 2:30 p.m. ET in New York. A live audio webcast of the presentation will be available here an ...

NEW HAVEN, Conn., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that three posters for vepdegestrant, including clinical data, will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), being held December 10-13, 2024, in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic estrogen re ...

Core Insights - Clearside Biomedical, Inc. has entered a commercial collaboration agreement with Arctic Vision and Santen Pharmaceutical Co., Ltd. for the commercialization of ARVN001 (XIPERE®) in China, targeting uveitic macular edema and other ophthalmic indications [1][2] - The partnership is expected to enhance the validation of Clearside's Suprachoroidal Space (SCS®) delivery platform, which is gaining traction among global pharmaceutical companies [2][3] - Arctic Vision has reported positive Phase 3 trial results for ARVN001 in China and is pursuing regulatory approvals in multiple Asia-Pacific countries [3] Company Overview - Clearside Biomedical specializes in innovative drug delivery systems for ocular diseases, utilizing its proprietary SCS Microinjector® to administer therapies directly to the back of the eye [5][9] - The company’s lead product, XIPERE®, is a corticosteroid suspension approved in the U.S. for treating macular edema associated with uveitis, and is commercially available through Bausch + Lomb [6][9] - Clearside is also developing a pipeline of small molecule candidates for ocular conditions, with its lead program, CLS-AX, for wet age-related macular degeneration, recently completing a Phase 2b trial [9] Market Context - Uveitis affects approximately 350,000 patients in the U.S. and over one million globally, with about one-third developing uveitic macular edema, a significant cause of vision loss [8] - The uveitis market is projected to grow to nearly $550 million in the U.S. and over $1 billion globally by 2024 [8]

Clinical Trials and Drug Development - Vepdegestrant demonstrated near-complete ER degradation in tumor cells and superior anti-tumor activity compared to fulvestrant in preclinical studies[98]. - In the ongoing Phase 1b clinical trial, the clinical benefit rate for vepdegestrant in combination with palbociclib was 63% across all dose levels[106]. - The median progression-free survival for patients treated with the recommended Phase 3 dose of 200 mg vepdegestrant in combination with 125 mg palbociclib was 13.9 months[104]. - The VERITAC-2 Phase 3 monotherapy clinical trial for vepdegestrant is expected to complete enrollment in Q4 2024, with top-line data anticipated in Q4 2024 or Q1 2025[102]. - The FDA granted Fast Track designation for vepdegestrant as a monotherapy for ER+/HER2- locally advanced or metastatic breast cancer[101]. - The ongoing TACTIVE-U trial is evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib, with initial safety data expected in Q4 2024[108]. - The clinical trials for vepdegestrant are designed to position it as a backbone ER-targeting therapy in breast cancer[99]. - ARV-102 is the first oral PROTAC protein degrader in development targeting neurodegenerative diseases, showing potential to cross the blood-brain barrier[109]. - At the 2024 Michael J. Fox Foundation Conference, it was demonstrated that orally delivered ARV-102 crosses the blood-brain barrier and achieves ~50% reduction in pathological tau in murine tauopathy models[111]. - The European Medicines Agency approved the clinical trial application for ARV-102 in Q4 2023, with the first-in-human Phase 1 trial initiated in Q1 2024[112]. - ARV-393 showed potent anti-tumor activity in preclinical models of B-cell lymphoma, leading to tumor regression in various models[115]. - The FDA cleared the IND for ARV-393, with the first-in-human Phase 1 trial initiated in Q2 2024 and patient recruitment ongoing[116]. Financial Performance and Revenue - Revenue for the three months ended September 30, 2024, was $102.4 million, a 196.5% increase from $34.6 million in the same period of 2023, primarily driven by $76.7 million from the Novartis License Agreement[165]. - For the nine months ended September 30, 2024, revenue totaled $204.2 million, up 67.9% from $121.6 million in the same period of 2023, mainly due to $122.1 million from the Novartis agreements[166]. - Other income for the three months ended September 30, 2024, was $11.7 million, an increase of $1.7 million from $10.0 million in the same period of 2023[172]. - For the nine months ended September 30, 2024, other income totaled $39.2 million, up $13.7 million from $25.5 million in the same period of 2023[173]. Research and Development Expenses - Total research and development expenses for the nine months ended September 30, 2024, were $264.9 million, a decrease of 6.0% compared to $284.5 million for the same period in 2023[149]. - Program-specific external expenses for ARV-471 were $63.8 million for the nine months ended September 30, 2024, down from $78.1 million in 2023, indicating an 18.5% reduction[149]. - Research and development expenses for the three months ended September 30, 2024, were $86.9 million, a slight increase of $1.0 million from $85.9 million in the same period of 2023[167]. - For the nine months ended September 30, 2024, research and development expenses decreased to $264.9 million from $284.5 million, a reduction of $19.6 million[168]. - The company expects research and development expenses to continue increasing substantially as ongoing clinical trials and new product candidates are developed[152]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, were $75.8 million, an increase of $53.2 million from $22.6 million in the same period of 2023, largely due to a $43.4 million loss on lease termination[170]. - For the nine months ended September 30, 2024, general and administrative expenses totaled $131.3 million, up $58.0 million from $73.3 million in the same period of 2023[171]. - General and administrative expenses are anticipated to rise as the company increases personnel to support research and development and commercial operations[156]. Cash and Financing - Cash, cash equivalents, restricted cash, and marketable securities totaled $1.1 billion as of September 30, 2024, down from $1.3 billion as of December 31, 2023[181]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling approximately $1.1 billion, expected to fund operations into 2027[189]. - Interest income earned on cash, cash equivalents, and marketable securities was $41.9 million for the nine months ended September 30, 2024, compared to $26.6 million for the same period in 2023, indicating a significant increase[195]. - The company expects to require substantial additional financing to support ongoing operations and product development, with no committed external funding currently available[190]. - The company has raised approximately $1.7 billion in gross proceeds since inception through various financing methods, including equity sales and collaborations[122]. - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying on collaborations and licensing for funding[126]. Collaborations and Agreements - The Novartis Transaction included a $150 million upfront payment and potential additional payments of up to $1.01 billion based on milestones for ARV-766[128]. - The Bayer Collaboration Agreement resulted in an upfront non-refundable payment of $17.5 million and an additional $12.0 million from inception through 2023, with potential milestone payments totaling up to $688.0 million[139]. - The Bayer Collaboration Agreement was terminated effective August 12, 2024, limiting future collaboration opportunities with Bayer[140]. - The company shares development costs equally with Pfizer under the Vepdegestrant (ARV-471) Collaboration Agreement, which may impact future financial performance[143]. - The Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer included an upfront payment of $650.0 million and eligibility for up to $1.4 billion in contingent payments based on regulatory and sales milestones[142]. Market Risks and Future Plans - The company is exposed to market risks, primarily interest rate sensitivities, affecting its interest-earning assets[195]. - The company plans to hire additional personnel to support research, product development, and future commercialization efforts[188]. - The company anticipates substantial increases in expenses as it continues clinical trials for product candidates, including vepdegestrant and ARV-102[188]. - The company plans to wind down the bavdegalutamide program after completing ongoing clinical trials, prioritizing ARV-766 for prostate cancer treatment[119]. - The company may need to relinquish valuable rights to technologies or revenue streams if it raises additional funds through collaborations or licensing arrangements[193]. - The company anticipates filing an IND application for its KRAS G12D program in 2025, currently in preclinical development[117].

Arvinas, Inc. (NASDAQ:ARVN) Q3 2024 Earnings Conference Call October 30, 2024 8:00 AM ET Company Participants Jeff Ball - Chief Financial Officer John Houston - Chief Executive Officer, President and Chairperson Noah Berkowitz - Chief Medical Officer Andrew Sake - Chief Financial Officer Angela Cacace - Chief Scientific Officer Conference Call Participants Akash Tewari - Jefferies Brad Canino - Stifel Etzer Darout - BMO Capital Markets Ellie Merle - UBS Derek Archila - Wells Fargo Li Watsek - Cantor Ted Ten ...

Arvinas, Inc. (ARVN) came out with a quarterly loss of $0.68 per share versus the Zacks Consensus Estimate of a loss of $0.88. This compares to loss of $1.18 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 22.73%. A quarter ago, it was expected that this company would post a loss of $0.72 per share when it actually produced a loss of $0.49, delivering a surprise of 31.94%. Over the last four quarters, the company has surpasse ...

Exhibit 99.1 Arvinas Reports Third Quarter 2024 Financial Results and Provides Corporate Update – On track to report topline data from Phase 3 VERITAC-2 trial in 4Q24 or 1Q25 – – Initial clinical data from Phase 1/2 TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant to be presented at San Antonio Breast Cancer Symposium in December 2024 – – Recently presented new preclinical data for the PROTAC LRRK2 degrader ARV-102 demonstrating that LRRK2 degradation affects biomarkers in the CSF – - $1 ...

– On track to report topline data from Phase 3 VERITAC-2 trial in 4Q24 or 1Q25 – – Initial clinical data from Phase 1/2 TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant to be presented at San Antonio Breast Cancer Symposium in December 2024 – – Recently presented new preclinical data for the PROTAC LRRK2 degrader ARV-102 demonstrating that LRRK2 degradation affects biomarkers in the CSF – - $1.1 billion in cash, cash equivalents and marketable securities as of Sept. 30, 2024 - – Company ...

NEW HAVEN, Conn., Oct. 22, 2024 (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 employees from 16 states participated in the Company’s third annual “Arvinas Impact Day,” a company-wide day of service where employees joined forces to give back to their communities, engaging in various volunteer activities that made a tangible difference across the Greater New Haven area and beyon ...