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 ...

NEW HAVEN, Conn., Oct. 21, 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 management will review third quarter 2024 financial results and provide a corporate update during a live webcast on Wednesday, October 30, 2024, 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 webcast will be a ...

Clinical Development - The company is progressing multiple product candidates through clinical development, including vepdegestrant for ER+/HER2- breast cancer, ARV-102 for neurodegenerative disorders, and ARV-393 for non-Hodgkin Lymphoma[107]. - The ongoing VERITAC-2 Phase 3 trial of vepdegestrant as a monotherapy for metastatic breast cancer is projected to complete enrollment in Q4 2024, with top-line data expected in Q4 2024 or Q1 2025[112]. - The company has several ongoing clinical trials for vepdegestrant, including VERITAC-3, VERITAC-2, and TACTIVE-N, with various enrollment statuses[109][110]. - The company is also evaluating vepdegestrant in combination with other therapies in ongoing clinical trials, including the I-SPY TRIAL[111]. - The European Medicines Agency cleared the clinical trial application for ARV-102 in Q4 2023, with dosing initiated in the first-in-human Phase 1 trial in Q1 2024[121]. - The FDA cleared the investigational new drug application for ARV-393, with the first-in-human Phase 1 clinical trial initiated in Q2 2024[124]. Product Efficacy - Vepdegestrant demonstrated near-complete ER degradation in tumor cells and superior anti-tumor activity compared to fulvestrant in preclinical studies[108]. - Updated clinical data from a Phase 1b trial showed a clinical benefit rate of 63% and a median progression-free survival of 11.2 months for vepdegestrant in combination with palbociclib[114]. - At the recommended Phase 3 dose of 200 mg vepdegestrant combined with 125 mg palbociclib, patients achieved a median progression-free survival of 13.9 months[114]. - Confirmed complete response, partial response, or stable disease rate (CBR) was 63% across all dose levels, with a CBR of 72% in patients with mutant ESR1 and 53% in patients with wild-type ESR1[117]. - Objective response rate (ORR) in evaluable patients was 42%, with a median duration of response (DOR) of 14.6 months; at the RP3D of 200 mg, ORR was 53%[117]. - Median progression-free survival (mPFS) was 11.2 months across all dose levels, with mPFS of 13.7 months in patients with ESR1 mutation[117]. - Exploratory ctDNA analyses showed a median change of -98.9% in tumor fraction after one treatment cycle, indicating significant tumor reduction[117]. - The safety profile of vepdegestrant in combination with palbociclib showed Grade 3/4 treatment-related adverse events, with neutropenia occurring in 91% of patients[117]. - ARV-393 showed anti-tumor activity in preclinical models of B-cell lymphoma, with rapid degradation of the BCL6 protein[123]. Collaborations and Licensing - The collaboration with Pfizer for vepdegestrant includes worldwide co-exclusive rights for development and commercialization[108]. - In April 2024, the company entered into a transaction with Novartis, receiving a one-time upfront payment of $150 million and is eligible for up to $1.01 billion in contingent payments based on milestones[133]. - Under the Novartis License Agreement, the company granted Novartis an exclusive worldwide license for the development and commercialization of ARV-766, a drug for prostate cancer[132]. - The Pfizer Research Collaboration Agreement includes an upfront payment of $28 million and potential milestone payments totaling up to $775 million, along with mid- to high-single digit tiered royalties[138]. - The Bayer Collaboration Agreement provided an upfront payment of $17.5 million and potential milestone payments totaling up to $688 million, with the agreement set to terminate in August 2024[141][143]. - The Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer included an upfront payment of $650 million and potential contingent payments of up to $1.4 billion based on milestones[144]. Financial Performance - Since inception, the company has raised approximately $1.7 billion in gross proceeds and received $913 million from collaboration partners[127]. - The company has not generated any revenue from product sales to date and does not expect to do so in the near future, with revenues derived from research collaborations and licensing agreements[131]. - Revenue for Q2 2024 was $76.5 million, a 40.2% increase from $54.5 million in Q2 2023, primarily due to $45.4 million from the Novartis License Agreement and Asset Agreement[163]. - Other income for Q2 2024 was $13.5 million, an increase of 50% from $9.0 million in Q2 2023, attributed to higher interest income from marketable securities[168]. - Net loss for Q2 2024 was $35.2 million, a significant improvement compared to a net loss of $66.6 million in Q2 2023, reflecting a decrease of $31.4 million[162]. Expenses and Cash Flow - Total research and development expenses for the first half of 2024 were $93.7 million, a decrease from $103.4 million in the same period of 2023[151]. - Research and development expenses for Q2 2024 totaled $93.7 million, a decrease of 9.7% from $103.4 million in Q2 2023, driven by reduced clinical trial costs[165]. - General and administrative expenses for Q2 2024 were $31.3 million, up 21.8% from $25.7 million in Q2 2023, mainly due to increased personnel and professional fees[167]. - The company expects research and development expenses to continue to increase substantially as it conducts ongoing clinical trials and develops additional product candidates[152]. - The company expects to incur increased general and administrative expenses in the future due to personnel growth and compliance costs associated with being a public company[155]. - The company anticipates significant increases in expenses as it continues clinical trials for product candidates, including vepdegestrant and ARV-102[181]. - As of June 30, 2024, cash, cash equivalents, restricted cash, and marketable securities totaled $1.2 billion, down from $1.3 billion as of December 31, 2023[174]. - Net cash used in operating activities for the six months ended June 30, 2024 increased by $132.7 million compared to the same period in 2023, primarily due to an increase in deferred revenue of $133.1 million related to the Novartis License Agreement[178]. - Net cash from investing activities decreased by $301.9 million for the six months ended June 30, 2024, primarily due to a net decrease in maturities and net sales of marketable securities[179]. - Net cash provided by financing activities increased by $3.0 million for the six months ended June 30, 2024, due to increased proceeds from the exercise of stock options[180]. - As of June 30, 2024, outstanding debt totaled $0.9 million, carrying a fixed interest rate of 3.25% per annum[189]. Future Outlook - The company plans to establish a sales, marketing, and distribution infrastructure to commercialize products upon obtaining marketing approval[182]. - The company expects to require substantial additional financing to support ongoing operations and product development[185]. - As of June 30, 2024, the company had cash, cash equivalents, restricted cash, and marketable securities totaling approximately $1.2 billion, expected to fund operations into 2027[183]. - The company has a lease for approximately 160,000 square feet of laboratory and office space, with base rent ranging from $7.7 million to $8.8 million annually over a ten-year term[184].

Arvinas, Inc. (ARVN) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.72. This compares to loss of $1.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 31.94%. A quarter ago, it was expected that this company would post a loss of $1.48 per share when it actually produced a loss of $0.97, delivering a surprise of 34.46%.Over the last four quarters, the company has surpassed ...

Exhibit 99.1 Arvinas Reports Second Quarter 2024 Financial Results and Provides Corporate Update – Completed enrollment in the study lead-in for the VERITAC-3 Phase 3 trial in the first-line setting; continued enrollment globally in multiple clinical trials of vepdegestrant in ER+/HER2- metastatic breast cancer, including the VERITAC-2 Phase 3 trial in the second-line setting– – Completion of enrollment in VERITAC-2 expected in 4Q24 and topline data readout now expected 4Q24/1Q25 – – Received $150 million u ...