Financial Data and Key Metrics Changes - The company reported $59.2 million in revenue for Q4 2024, a significant increase from a negative $43.1 million in Q4 2023, resulting in a $102.3 million change [39] - For the full year 2024, revenue reached $263.4 million, compared to $78.5 million in 2023 [40] - Cash, cash equivalents, and marketable securities at the end of Q4 2024 were just over $1 billion, down from $1.3 billion at the end of 2023 [38] Business Line Data and Key Metrics Changes - The company is advancing its vepdegestrant (vepdeg) program, with ongoing Phase 3 trials and plans for combination trials in 2025 [10][13] - Research and development expenses for Q4 2024 were $83.3 million, a decrease from $95.2 million in Q4 2023, primarily due to a net decrease in external expenses [41] - General and administrative expenses for Q4 2024 were $34.1 million, up from $27 million in Q4 2023, driven by costs related to commercial operations and personnel [40] Market Data and Key Metrics Changes - The company is focused on the oncology and neuroscience markets, with significant advancements in its PROTAC platform aimed at treating various cancers and neurodegenerative diseases [9][10] - The upcoming Phase 3 trial results for vepdeg are expected to influence the treatment landscape for ER-positive/HER2-negative breast cancer [11][12] Company Strategy and Development Direction - The company aims to transition to a commercial stage with the potential approval of its first PROTAC degrader, vepdeg, pending positive trial results [11][45] - Plans include initiating Phase 3 combination trials for vepdeg with CDK4 inhibitors in both first- and second-line settings in 2025 [13][21] - The company is also advancing its neuroscience pipeline, including ARV-102 for neurodegenerative diseases, with first-in-human data expected in April 2025 [14][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming topline data from the VERITAC-2 trial, which could mark a significant milestone for the company [11][45] - The company is well-capitalized to support operations into 2027, allowing for continued investment in its clinical programs [38][42] - Management highlighted the importance of addressing unmet medical needs in both oncology and neuroscience [9][14] Other Important Information - The company is preparing for its first commercial launch and is focused on building its commercial organization [70] - There was a leadership change with the departure of the Chief Commercial Officer, but the company has a capable interim replacement [110] Q&A Session Summary Question: What is the cadence of data from TACTIVE-U cohorts? - Management indicated that data from TACTIVE-U will mature over time, and updates will be shared as they become available [53][55] Question: What level of degradation is considered therapeutic for LRRK2? - Management stated that a 50% reduction of LRRK2 is considered disease-modifying based on preclinical data [58][60] Question: What data is needed to gain confidence from KOLs on the vepdeg and atirmociclib combination? - Management noted that KOLs would expect to see more than 5-6 months of improvement in median PFS to consider the combination substantially different [91] Question: How does the company view the competitive landscape for the KRAS G12D degrader? - Management expressed confidence in their KRAS degrader's potency and differentiated mechanism of action compared to competitors [95][96] Question: What is the enrollment status for ARV-393? - Management reported that enrollment is progressing well, with a focus on non-Hodgkin lymphoma patients [104][106] Question: How is the company preparing for the commercial launch? - Management confirmed that significant planning is underway for the commercial organization, with a focus on collaboration with Pfizer [70][110]

Exhibit 99.1 Arvinas Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update – Announced that topline data from the monotherapy Phase 3 VERITAC-2 trial is anticipated in 1Q25 – Vepdegestrant: Oral PROTAC ER degrader • Announced that the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in ER+/HER2- metastatic breast cancer remains on track, with topline data anticipated in 1Q25 (ClinicalTrials.gov Identifier: NCT05654623). • Announced plans to initiate t ...

NEW HAVEN, Conn., Feb. 03, 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 fourth quarter and full year ended 2024 financial results and provide a corporate update during a live webcast on Tuesday, February 11, 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 th ...

Investors looking for stocks that could make dramatic moves in a short, defined time frame will want to turn their attention toward two innovative drugmakers. A couple of stocks in the volatile biopharmaceutical industry are poised to soar by the end of March.Results from clinical trials that wrap up soon could soon push shares of Recursion Pharmaceuticals (RXRX 2.03%), and Arvinas (ARVN 2.67%) through the roof. Both companies are expected to report their highly anticipated data any day now.Before you get e ...

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 ...