Earnings release
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ARVINAS Arvinas Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 3 , 2021 NEW HAVEN , Conn . , Nov. 03 , 2021 ( GLOBE NEWSWIRE ) -- Arvinas , Inc. ( Nasdaq : ARVN ) , a clinical - stage biotechnology company creating a new class of drugs based on targeted protein degradation , today reported financial results for the third quarter ended September 30 , 2021 and provided a corporate update . " The team at Arvinas has made a number of significant achievements throughout the year , from initiating multiple clinical trials to completing a potentially transformational collaboration with Pfizer , further establishing our leadership position in the field of targeted protein degradation , " said John Houston , Ph.D. , chief executive officer at Arvinas . " We believe the upcoming presentation of data from the completed Phase 1 dose escalation study with ARV - 471 for the treatment of patients with locally advanced or metastatic ER + / HER2- breast cancer sets us up for a strong finish to what so far has been an important year of execution . " " As we look ahead , our collaboration with Pfizer has enabled us to further evaluate the most efficient development pathway for ARV - 471 , " continued Dr. Houston . " In addition to initiating multiple planned Phase 3 studies with ARV - 471 in 2022 , we now intend to initiate the Phase 1b combination study with everolimus , potentially as part of a planned umbrella study with multiple combination agents with Pfizer , as well as the neoadjuvant study , in 2022 . Additionally , we expect to present the full dose escalation data from the ARV - 110 Phase 1 trial and an interim readout from the ARDENT Phase 2 expansion trial at ASCO Genitourinary Cancers Symposium in February 2022 , an opportunity to showcase a more complete picture of the potential of ARV - 110 in metastatic castration - resistant prostate cancer . " Business Highlights and Recent Developments • Initiated Phase 1b combination trial with ARV - 110 and abiraterone for the treatment of metastatic castration - resistant prostate cancer ( mCRPC ) . • Completed global collaboration with Pfizer that included an upfront payment to Arvinas of $ 650 million , a $ 350 million equity investment from Pfizer , and $ 1.4 billion in potential milestone payments to co - develop and co - commercialize ARV - 471 to the treatment of patients with ER + breast cancer . Arvinas and Pfizer will equally share worldwide development costs , commercialization expenses , and profits . Anticipated Milestones and Expectations ARV - 471 • Present Phase 1 dose escalation trial data ( San Antonio Breast Cancer Symposium , December 2021 ) • Present data from the VERITAC Phase 2 expansion trial ( 200 and 500 mg ) ( 2022 ) • Present safety data from the Phase 1b combination study with palbociclib ( 2022 ) • Initiate multiple Phase 3 trials in metastatic breast cancer ( as monotherapy and in combination ) ( 2022 ) • Initiate Phase 1b combination trial with everolimus in 2L / 3L metastatic breast cancer , potentially as part of a planned umbrella study with Pfizer to explore multiple combination agents ( 2022 ) • Initiate Phase 2 neoadjuvant trial in early breast cancer ( 2022 ) ARV - 110 • Present completed Phase 1 dose escalation data at ASCO Genitourinary Cancers Symposium ( February 2022 ) • Present interim data from the ARDENT Phase 2 dose expansion ( 420 mg ) at ASCO Genitourinary Cancers Symposium ( February 2022 ) ARV - 766 • Announce Phase 1 dose escalation data in mCRPC ( 2022 ) • Initiate Phase 2 expansion trial in mCRPC ( 2022 ) Third Quarter Financial Results Cash , Cash Equivalents , Restricted Cash and Marketable Securities Position : As of September 30 , 2021 , cash , cash equivalents , restricted cash and marketable securities were $ 1,549.0 million as compared with $ 688.5 million as of December 31 , 2020. The increase in cash , cash equivalents , restricted cash and marketable securities of $ 860.5 million for the first nine months of 2021 was primarily related to cash received from the global Pfizer collaboration agreement to develop and commercialize ARV - 471 ( ARV - 471 Collaboration Agreement ) of $ 650.0 million , the equity investment by Pfizer of $ 350.0 million and proceeds from the exercise of stock options of $ 14.7 million , partially offset by cash used in operating activities of $ 133.9 million ( net of $ 4.2 million received from two collaborators ) , professional fees associated with the global Pfizer collaboration and equity investment of $ 17.5 million , and the purchase of lab equipment and leasehold improvements of $ 2.8 million . Research and Development Expenses : Research and development expenses were $ 40.6 million for the quarter ended September 30 , 2021 , as