1. NEW HAVEN, Conn. and NEW YORK, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN) and Pfizer Inc. (NYSE:PFE) announced today that updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471, a novel oral estrogen receptor (ER)-targeting PROteolysis TArgeting Chimera (PROTAC®) protein degrader, will be presented in a spotlight poster-discussion session at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-10, 2021. ARV-471 is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

    Presentation details are as follows:

    Abstract Title

    NEW HAVEN, Conn. and NEW YORK, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN) and Pfizer Inc. (NYSE:PFE) announced today that updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471, a novel oral estrogen receptor (ER)-targeting PROteolysis TArgeting Chimera (PROTAC®) protein degrader, will be presented in a spotlight poster-discussion session at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-10, 2021. ARV-471 is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

    Presentation details are as follows:

    Abstract Title: First-in-human safety and activity of ARV-471, a novel PROTAC® estrogen receptor degrader, in ER+/HER2- locally advanced or metastatic breast cancer

    Session Title: Spotlight Session 13

    Abstract Number: 2343

    Session Type: Spotlight Poster-Discussion Session

    Session Date: Friday, December 10, 2021

    Session Time: 7:00 a.m. - 8:30 a.m. CT

    For a copy of the abstract, please visit the official SABCS website here.

    Investor Call & Webcast Details

    A conference call and webcast will be held at 8:30 a.m. ET on Friday, December 10, 2021, with Arvinas and Pfizer Oncology executives to discuss these data. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 9122219.

    Supporting materials for the conference call and webcast will be available on Arvinas' website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: ARV-110 and ARV-766 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Arvinas Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of our arrangements with our collaborative partnership with Pfizer, the development and regulatory status of our product candidates, such as statements with respect to our lead product candidates, ARV-110, ARV-471 and ARV-766 and other candidates in our pipeline, and the timing of clinical trials and data from those trials and plans for registration for our product candidates, and our discovery programs that may lead to our development of additional product candidates, the potential utility of our technology and therapeutic potential of our product candidates, the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we and Pfizer will be able to successfully conduct and complete clinical development for ARV-471, whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-766, initiate and complete other clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    About Pfizer Oncology

    At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Forward-Looking Statements

    The information contained in this release is as of November 19, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about ARV-471 and a global collaboration between Pfizer and Arvinas to develop and commercialize ARV-471, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for ARV-471 for any potential indications in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for ARV-471 in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ARV-471 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ARV-471; whether the collaboration between Pfizer and Arvinas will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Arvinas Media Contacts

    Investor Contact:

    Jeff Boyle, Arvinas Investor Relations

    347-247-5089

    Media Contact:

    Kirsten Owens, Arvinas Communications

    203-584-0307

    Pfizer Media Contacts

    Investor Contact:

    +1 (212) 733-4848

    Media Contact:

    +1 (212) 733-1226

      



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  2. NEW HAVEN, Conn., Nov. 10, 2021 (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 Sean Cassidy, Chief Financial Officer, and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16 at 10:40 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering…

    NEW HAVEN, Conn., Nov. 10, 2021 (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 Sean Cassidy, Chief Financial Officer, and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16 at 10:40 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: ARV-110 and ARV-766 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Investor Contact:

    Jeff Boyle

    (347) 247-5089

    Media Contact:

    Kirsten Owens

    (203) 584-0307



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  3. 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…

    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 compared with $30.0 million for the quarter ended September 30, 2020. The increase in research and development expenses of $10.6 million for the quarter was primarily due to an increase in our continued investment in our platform and exploratory programs of $9.0 million and an increase in expenses related to our AR program (which includes ARV-110 and ARV-766) of $3.5 million, partially offset by a decrease in our ER program of $1.9 million, which includes the cost sharing of ARV-471 under the ARV-471 Collaboration Agreement with Pfizer.

    General and Administrative Expenses: General and administrative expenses were $16.0 million for the quarter ended September 30, 2021, as compared with $9.3 million for the quarter ended September 30, 2020. The increase of $6.7 million was primarily due to an increase in personnel and facility related costs of $5.0 million and insurance and professional fees of $1.7 million.

    Revenues: Revenues were $9.3 million for the quarter ended September 30, 2021 as compared to $7.6 million for the quarter ended September 30, 2020. Revenue is related to the ARV-471 Collaboration Agreement with Pfizer that was initiated in July 2021, the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The increase in revenues of $1.7 million was primarily due to revenue from the ARV-471 Collaboration Agreement with Pfizer, partially offset by the addition of new targets added in 2020 under the January 2018 Pfizer Collaboration Agreement extending the revenue recognition period.



    Net Loss: Net loss was $46.8 million for the quarter ended September 30, 2021, as compared with $30.8 million for the quarter ended September 30, 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses, partially offset by increased revenue.

    About ARV-110

    ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About ARV-766

    ARV-766 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

    ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: ARV-110 and ARV-766 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of the collaboration and the potential advantages and therapeutic benefits of ARV-471, ARV-110, ARV-766 and our other product candidates, the future development and potential marketing approval and commercialization of ARV-471, ARV-110, ARV-766 and our other product candidates, including the timing of data from and initiation of our clinical trials. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: each party's performance of its obligations under the Pfizer collaboration, whether we and, as applicable, Pfizer will be able to successfully conduct and complete clinical development, including whether we receive results from our clinical trials on our expected timelines or at all, obtain marketing approval for and commercialize ARV-471, ARV-110, ARV-766 and our other product candidates on our current timelines or at all and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.



    Investor Contact:

    Jeff Boyle

    (347) 247-5089

    Media Contact:

    Kirsten Owens

    (203) 584-0307







    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
        
     September 30,  December 31,
      2021   2020 
    Assets   
    Current assets:   
    Cash and cash equivalents$255,662,835  $588,373,232 
    Restricted cash 4,500,000    
    Marketable securities 1,288,814,399   100,157,618 
    Accounts receivable 1,880,180   1,000,000 
    Other receivables 6,755,720   7,443,654 
    Prepaid expenses and other current assets 18,537,587   6,113,122 
    Total current assets 1,576,150,721   703,087,626 
    Property, equipment and leasehold improvements, net 11,628,051   12,259,515 
    Operating lease right of use assets 4,250,463   1,992,669 
    Collaboration contract asset and other assets 12,835,975   28,777 
    Total assets$1,604,865,210  $717,368,587 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$4,671,605  $7,121,879 
    Accrued expenses 13,769,220   18,859,840 
    Deferred revenue 162,943,830   22,150,861 
    Current portion of operating lease liabilities 1,123,101   952,840 
    Total current liabilities 182,507,756   49,085,420 
    Deferred revenue 600,429,165   22,938,233 
    Long term debt 1,000,000   2,000,000 
    Operating lease liability 3,191,132   1,087,422 
    Total liabilities 787,128,053   75,111,075 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock, $0.001 par value; 52,766,020 and 48,455,741 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively 52,766   48,455 
    Accumulated deficit (629,893,515)  (491,888,910)
    Additional paid-in capital 1,448,254,555   1,133,537,171 
    Accumulated other comprehensive (loss) income (676,649)  560,796 
    Total stockholders' equity 817,737,157   642,257,512 
    Total liabilities and stockholders' equity$1,604,865,210  $717,368,587 



    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
          
     Three Months Ended September 30,  Nine Months Ended September 30,
      2021  2020   2021  2020 
    Revenue$9,284,785 $7,596,776  $20,368,568 $19,584,085 
    Operating expenses:     
    Research and development 40,603,631  30,012,918   118,481,320  75,155,694 
    General and administrative 16,012,384  9,331,925   42,741,962  26,072,404 
    Total operating expenses 56,616,015  39,344,843   161,223,282  101,228,098 
    Loss from operations (47,331,230) (31,748,067)  (140,854,714) (81,644,013)
    Interest and other income 579,478  928,201   2,850,109  3,858,437 
    Net loss$(46,751,752)$(30,819,866) $(138,004,605)$(77,785,576)
    Net loss per common share, basic and diluted$(0.94)$(0.79) $(2.81)$(2.01)
    Weighted average common shares outstanding, basic and diluted 49,807,508  39,058,294   49,101,927  38,784,569 


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  4. SAN FRANCISCO, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders, today announced that it has appointed Brad Margus to its board of directors. Mr. Margus brings over 30 years of company building and corporate leadership experience including over 20 years in the development of therapeutics for central nervous system (CNS) diseases.

    "It is my great pleasure to welcome Brad to the Neurona board of directors," said Cory Nicholas, Ph.D., Neurona's president and chief executive officer. "Determined to decode devastating neurodegenerative disease, he has worked tirelessly to advance new technology platforms that fuel novel…

    SAN FRANCISCO, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders, today announced that it has appointed Brad Margus to its board of directors. Mr. Margus brings over 30 years of company building and corporate leadership experience including over 20 years in the development of therapeutics for central nervous system (CNS) diseases.

    "It is my great pleasure to welcome Brad to the Neurona board of directors," said Cory Nicholas, Ph.D., Neurona's president and chief executive officer. "Determined to decode devastating neurodegenerative disease, he has worked tirelessly to advance new technology platforms that fuel novel diagnostic and therapeutic pipelines. He has done everything from forming non-profit initiatives, organizing scientific conferences, creating research funding opportunities and resources and more recently to building successful CNS disease-focused companies. We look forward to benefitting from his broad expertise and passion for advancing therapeutic solutions for disorders of the brain as we work to advance our first NRTX-1001 program into a clinical trial for epilepsy this year."

    "I am excited by Neurona's innovative regenerative cell therapy platform and its initial application in an off-the-shelf therapy that has the potential to broaden treatment options for people with drug resistant focal epilepsy," said Mr. Margus. "I look forward to working with the talented Neurona team and board of directors to help build and grow the company as it brings its neural cell therapy candidates to patients as expeditiously as possible."

    Mr. Margus is a co-founder and the chief executive officer of Cerevance, a private, clinical-stage pharmaceutical company focused on diseases of the central nervous system. His drive to advance new therapeutics for brain diseases was ignited in the mid- 1990s when he formed a nonprofit (the A-T Children's Project), raised over $50 million from donors through nationwide grassroots efforts, organized scientific conferences, funded research projects worldwide, created tissue banks, established a clinic at Johns Hopkins Hospital, and coordinated clinical trials. He also advocated for other genetic disorders, frequently testifying before Congress.

    In addition to Cerevance, Mr. Margus has co-founded several biotechnology companies including Perlegen Sciences, a tools and diagnostics company focused on using genetic variation to improve clinical decision making, and Envoy Therapeutics, focused on advancing a pipeline of compounds that acted on proteins selectively expressed in the disrupted circuitry of brain diseases. Envoy Therapeutics was acquired by Takeda Pharmaceuticals in 2012.

    Mr. Margus helped to form the Global Alliance for Genomics and Health, a coalition of over 500 academic medical centers, funding organizations, patient groups, technology providers and government agencies to establish technical and ethical standards for the secure sharing of genomic data, and served as founding CEO of Genome Bridge, a non-profit subsidiary of the Broad Institute of Harvard and M.I.T., to build a scalable computational platform for aggregating, analyzing and sharing genomic and clinical data.

    Mr. Margus also serves on the board of Arvinas (NASDAQ:ARVN), a protein degradation company, as volunteer Chairman of the A T Children's Project, Co-chair of the Network for Excellence in Neuroscience Clinical Trials External Oversight Board at the NIH and the board of Global Genes, a non-profit organization that advocates on behalf of all rare diseases.

    He has previously served on the Advisory Council to the National Institute of Neurological Disorders and Stroke at the NIH; the Secretary of Health and Human Services' Advisory Committee on Genetics, Health and Society; as a member of the National Center for Advancing Translational Sciences Advisory Council and the Cure Acceleration Network Review Board (both at the NIH), the Board of the Genetic Alliance, an umbrella organization representing hundreds of genetic disease advocacy organizations; as an advisor to Counsyl, Inc. (acquired by Myriad Genetics); the Board of Children's Neurobiological Solutions, an organization aimed at applying brain repair and regeneration to pediatric neurological disorders; the Board of Cellular Research, a molecular biology tool company (acquired by Becton Dickinson); the Board of Second Genome, a microbiome company; the Board of Presage Biosciences, an oncology company, as a Harvard Business School Global Advisor; and on the Stanford University School of Medicine's Stem Cell Research Oversight Committee. Mr. Margus holds an MBA from Harvard Business School.

    About NRTX-1001

    NRTX-1001 is an inhibitory nerve cell therapy derived from human pluripotent stem cells. The nerve cells, called interneurons, secrete the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyperexcitable neural networks that underlie epilepsy as well as other disorders of the nervous system. Neurona is initially focused on developing NRTX-1001 as a restorative treatment for mesial temporal lobe epilepsy (MTLE), which is the most common type of focal epilepsy.

    About MTLE

    Mesial temporal lobe epilepsy (MTLE) involves the internal structures of the temporal lobe. Seizures often begin in a structure of the brain called the hippocampus. MTLE accounts for almost 80% of all temporal lobe seizures. For people with seizures that are resistant to drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or laser ablated, can be an option for some. However, current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.

    About Neurona

    Neurona's cell therapies have single-dose curative potential. Based on a novel neural cell lineage developed by the company's scientific founders, Neurona has built a robust regenerative platform and is developing restorative neuronal, glial, and gene-edited cell therapy candidates that provide long-term integration and repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit www.neuronatherapeutics.com

    Neurona Therapeutics

    Investor and Media Contacts:

    Sylvia Wheeler

    Wheelhouse LSA





    Elizabeth Wolffe, Ph.D.

    Wheelhouse LSA







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  5. NEW HAVEN, Conn., Sept. 01, 2021 (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 it will participate in two upcoming virtual investor conferences:

    Citi 16th Annual BioPharma Virtual Conference on Thursday, September 9, 2021. John Houston, Ph.D., President and Chief Executive Officer, and Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at 9:45 a.m. ET. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company's website.

    2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021. Sean Cassidy, Chief Financial…

    NEW HAVEN, Conn., Sept. 01, 2021 (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 it will participate in two upcoming virtual investor conferences:

    Citi 16th Annual BioPharma Virtual Conference on Thursday, September 9, 2021. John Houston, Ph.D., President and Chief Executive Officer, and Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at 9:45 a.m. ET. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company's website.

    2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021. Sean Cassidy, Chief Financial Officer, and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at 9:20 a.m. ET. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company's website.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: ARV-110 and ARV-766 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  6. HONG KONG, Aug. 9, 2021 /PRNewswire/ -- Insilico Medicine is proud to announce an R&D collaboration with Arvinas (NASDAQ:ARVN). This strategic partnership will involve Insilico Medicine's AI-augmented platforms and close cooperation between Arvinas' and Insilico Medicine's scientists on novel PROTACs. The collaboration will include the design of transformative treatment modalities for existing and next-generation targets; and demonstrate the impact of combining AI with one of the most significant breakthrough technologies in drug discovery - PROTACs.

    "Arvinas is the pioneer of PROTAC technology and a leader in protein degradation therapeutics. We look forward to collaborating with Arvinas in this innovative field and to building a lasting relationship," said Alex Zhavoronkov Ph.D., CEO of Insilico Medicine.

    In July the company announced the completion of a $255 million round led by Warburg Pincus and joined by over 25 high-profile investors, and in August,  it nominated the second preclinical candidate for kidney fibrosis.

    About Insilico Medicine

    Insilico Medicine, an end-to-end artificial intelligence-driven drug discovery company, is developing artificial intelligence platforms. These platforms use deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, infectious diseases, autoimmune diseases, and ageing-related diseases. Since its inception, Insilico Medicine has raised over $300 million from reputable financial, biotechnology, and information technology investors.

    Website http://insilico.com/

    Media Contact

    For further information, images, or interviews, please contact .

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/insilico-medicine-announces-an-ai-driven-protac-rd-collaboration-with-arvinas-301351106.html

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  7. NEW HAVEN, Conn., Aug. 05, 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 second quarter ended June 30, 2021 and provided a corporate update.

    "Arvinas has made tremendous progress throughout the first half of 2021 and July, highlighted by our global collaboration with Pfizer to co-develop and potentially co-commercialize our estrogen receptor-targeting PROTAC degrader, ARV-471. This collaboration has the potential to be transformational, combining Arvinas' leadership in targeted protein degradation with Pfizer's global capabilities to enhance and potentially accelerate the development…

    NEW HAVEN, Conn., Aug. 05, 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 second quarter ended June 30, 2021 and provided a corporate update.

    "Arvinas has made tremendous progress throughout the first half of 2021 and July, highlighted by our global collaboration with Pfizer to co-develop and potentially co-commercialize our estrogen receptor-targeting PROTAC degrader, ARV-471. This collaboration has the potential to be transformational, combining Arvinas' leadership in targeted protein degradation with Pfizer's global capabilities to enhance and potentially accelerate the development of ARV-471," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas.

    "Through the rest of the year, we look forward to advancing our entire pipeline of PROTAC® targeted protein degraders and to several important data milestones, including interim data from the ARDENT Phase 2 trial of our androgen receptor-degrading PROTAC degrader, ARV-110, and Phase 1 dose escalation data from ARV-471 and ARV-110," continued Dr. Houston.

    Business Highlights and Recent Developments

    • Announced a global collaboration with Pfizer to co-develop and co-commercialize ARV-471 for the treatment of patients with ER+ breast cancer. The deal includes an upfront payment to Arvinas of $650 million, a $350 million equity investment from Pfizer, and $1.4 billion in potential milestone payments. Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.
    • Initiated the first-in-human study of ARV-766, an androgen receptor (AR) degrader with a differentiated profile from ARV-110, in patients with metastatic castration-resistant prostate cancer.
    • Completed dose escalation in the Phase 1 study of ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.
    • Completed dose escalation in the Phase 1 study of ARV-110 for the treatment of metastatic castrate-resistant prostate cancer.

    Anticipated Milestones and Expectations

    ARV-471

    • Presentation of Phase 1 dose escalation trial data (at the San Antonio Breast Cancer Symposium, December 2021)
    • Initiation of a neoadjuvant study in early breast cancer (2H21)
    • Initiation of a combination trial of ARV-471 and everolimus in 2L/3L metastatic breast cancer (2H21)

    ARV-110

    • Presentation of completed Phase 1 dose escalation data (2H21)
    • Presentation of interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
    • Initiation of combination trial with abiraterone (2H21)

    Second Quarter Financial Results

    Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2021, cash, cash equivalents, and marketable securities were $605.1 million as compared with $688.5 million as of December 31, 2020. The cash, cash equivalents and marketable securities amounts do not reflect the global Pfizer collaboration agreement upfront payment of $650 million that was received in July 2021, or the equity investment by Pfizer of $350 million (which is subject to certain conditions including clearance under the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended). The decrease in cash, cash equivalents and marketable securities of $83.4 million for the first six months of 2021 was primarily related to net cash used in operating activities of $86.4 million (net of $4.0 million received from two collaborators), the purchase of lab equipment and lease-hold improvements of $1.5 million and net accretion of discounts/premiums and unrealized loss on marketable securities of $3.6 million, partially offset by cash provided from the exercise of stock options of $8.1 million.

    Research and Development Expenses: Research and development expenses were $43.0 million for the quarter ended June 30, 2021, as compared with $23.4 million for the quarter ended June 30, 2020. The increase in research and development expenses of $19.6 million for the quarter was primarily related to increases in clinical trial and CMC expenses associated with our AR program of $7.3 million and our ER program of $3.4 million, in addition to increases in preclinical expenses of $8.9 million associated with exploratory programs and investments in platform research.

    General and Administrative Expenses: General and administrative expenses were $14.4 million for the quarter ended June 30, 2021, as compared to $8.8 million for the quarter ended June 30, 2020. The increase of $5.6 million was primarily related to an increase in personnel costs, facility related costs and professional fees.

    Revenue: Revenue was $5.5 million for the quarter ended June 30, 2021, as compared with $5.7 million for the quarter ended June 30, 2020. Revenue is generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The decrease of $0.2 million for the quarter was primarily related to a collaborator adding new targets in previous periods that extended the period of revenue recognition for that collaboration agreement.

    Interest and Other Income:  Interest and other Income was $1.6 million for the quarter ended June 30, 2021 as compared with $1.3 million for the quarter ended June 30, 2020. The increase of $0.3 million was primarily due to forgiveness of debt of $1.0 million, related to a State of Connecticut loan which was partially forgiven upon our satisfaction of certain jobs criteria, partially offset by lower interest income and lower refundable research and development credits from the State of Connecticut.

    Net Loss: Net loss was $50.3 million for the quarter ended June 30, 2021, as compared with $25.2 million for the quarter ended June 30, 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.

    About ARV-110

    ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

    About ARV-766

    ARV-766 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade androgen receptor (AR). In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR tested, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

    ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: ARV-110 and ARV-766 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the receipt of upfront, milestone and other payments under the Pfizer collaboration, the investment by Pfizer in Arvinas common stock in connection with the collaboration, the potential benefits of the collaboration and the potential advantages and therapeutic benefits of ARV-471, ARV-110, ARV-766 and our other product candidates, the future development and potential marketing approval and commercialization of ARV-471, ARV-110, ARV-766 and our other product candidates, including the timing of data from our clinical trials. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: the satisfaction or waiver of the conditions to the closing of the Pfizer equity investment, each party's performance of its obligations under the collaboration, whether we and, as applicable, Pfizer will be able to successfully conduct and complete clinical development, including whether we receive results from our clinical trials on our expected timelines or at all, obtain marketing approval for and commercialize ARV-471, ARV-110, ARV-766 and our other product candidates on our current timelines or at all and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
        
     June 30,  December 31,
      2021   2020 
    Assets   
    Current assets:   
    Cash and cash equivalents$48,726,443  $588,373,232 
    Restricted cash 4,500,000    
    Marketable securities 551,849,110   100,157,618 
    Account receivable    1,000,000 
    Other receivables 7,415,611   7,443,654 
    Prepaid expenses and other current assets 15,242,798   6,113,122 
    Total current assets 627,733,962   703,087,626 
    Property, equipment and leasehold improvements, net 11,699,480   12,259,515 
    Operating lease right of use assets 4,564,666   1,992,669 
    Other assets 28,777   28,777 
    Total assets$644,026,885  $717,368,587 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$4,975,367  $7,121,879 
    Accrued expenses 13,472,966   18,859,840 
    Deferred revenue 22,150,861   22,150,861 
    Current portion of operating lease liabilities 1,221,152   952,840 
    Total current liabilities 41,820,346   49,085,420 
    Deferred revenue 14,862,802   22,938,233 
    Long term debt, net of current portion 1,000,000   2,000,000 
    Operating lease liabilities 3,396,563   1,087,422 
    Total liabilities 61,079,711   75,111,075 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock, $0.001 par value, 48,994,869 and 48,455,741 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively 48,995   48,455 
    Accumulated deficit (583,141,763)  (491,888,910)
    Additional paid-in capital 1,166,526,486   1,133,537,171 
    Accumulated other comprehensive income (486,544)  560,796 
    Total stockholders' equity 582,947,174   642,257,512 
    Total liabilities and stockholders' equity$644,026,885  $717,368,587 
        



    Arvinas, Inc.   
    Consolidated Statement of Operations (Unaudited)   
          
     Three Months Ended June 30,  Six Months Ended June 30,
      2021  2020   2021  2020 
    Revenue$5,544,418 $5,747,681  $11,083,783 $11,987,309 
    Operating expenses:     
    Research and development 43,010,807  23,416,090   77,877,689  45,142,776 
    General and administrative 14,410,865  8,815,474   26,729,578  16,740,479 
    Total operating expenses 57,421,672  32,231,564   104,607,267  61,883,255 
    Loss from operations (51,877,254) (26,483,883)  (93,523,484) (49,895,946)
    Interest and other income 1,588,692  1,257,344   2,270,631  2,930,236 
    Net loss$(50,288,562)$(25,226,539) $(91,252,853)$(46,965,710)
    Net loss per common share, basic and diluted$(1.03)$(0.65) $(1.87)$(1.22)
    Weighted average common shares outstanding, basic and diluted 48,860,930  38,739,922   48,741,296  38,644,209 
          

     



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  8. – Collaboration combines Arvinas' investigational estrogen receptor-targeting breast cancer therapy with Pfizer's deep experience in breast oncology therapeutics –

    – ARV-471 is currently in Phase 2 development for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer –

    – Arvinas to receive $650 million in an upfront payment, in addition to a potential $1.4 billion in milestone payments; profits and costs to be shared 50/50 worldwide –

    – Pfizer to complete a $350 million equity investment in Arvinas –

    – Investor call on ARV-471 collaboration to take place at 8:30AM ET today with Arvinas and Pfizer Oncology executives -

    NEW HAVEN, Conn. and NEW YORK, July 22, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ…

    – Collaboration combines Arvinas' investigational estrogen receptor-targeting breast cancer therapy with Pfizer's deep experience in breast oncology therapeutics –

    – ARV-471 is currently in Phase 2 development for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer –

    – Arvinas to receive $650 million in an upfront payment, in addition to a potential $1.4 billion in milestone payments; profits and costs to be shared 50/50 worldwide –

    – Pfizer to complete a $350 million equity investment in Arvinas –

    – Investor call on ARV-471 collaboration to take place at 8:30AM ET today with Arvinas and Pfizer Oncology executives -

    NEW HAVEN, Conn. and NEW YORK, July 22, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN) and Pfizer Inc. (NYSE:PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. Under the terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will make a $350 million equity investment in Arvinas. The companies will equally share worldwide development costs, commercialization expenses, and profits.

    "This collaboration has the potential to be transformational, as it combines our leadership in targeted protein degradation with Pfizer's global capabilities and deep expertise in breast cancer. This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas' strategy of building a global, integrated biopharmaceutical company," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "We share Pfizer's deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer. Together with Pfizer, we will deploy our PROTAC technology in an effort to help people with this devastating disease."

    "Building on Pfizer's established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer," said Jeff Settleman, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer. "This partnership complements Pfizer's robust research activities in breast cancer, including our multiple next-generation CDK inhibitors currently in early clinical development."

    ER is the primary driver of hormone receptor (HR) positive breast cancer, which is the most common breast cancer subtype. Endocrine therapy is a backbone of ER+ breast cancer treatment and is used as monotherapy or as combination therapy as a standard of care across treatment settings. Arvinas and Pfizer are seeking to develop ARV-471 as the potential endocrine therapy of choice for patients and their physicians.

    Interim data presented in December 2020 from the ongoing Phase 1 dose escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer indicated its potential as a novel oral ER targeted therapy. This study has enrolled heavily pretreated patients, with all patients having received prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors. Despite the advanced stage of disease and heavy pretreatment, these interim data, as of December 2020, demonstrated that ARV-471 can promote substantial ER degradation and exhibits an encouraging clinical efficacy and tolerability profile.

    ARV-471 currently is being evaluated as a treatment for metastatic breast cancer in a Phase 1 dose escalation study, a Phase 1b combination study with Pfizer's IBRANCE® (palbociclib), and a Phase 2 monotherapy dose expansion study (VERITAC). Arvinas and Pfizer expect to initiate two additional trials of ARV-471 in 2021, including a second Phase 1b combination trial with everolimus and a trial in the neoadjuvant setting. In 2022, Arvinas and Pfizer expect to initiate Phase 3 studies across lines of therapy in metastatic breast cancer, including combinations with IBRANCE, followed by pivotal studies in the early breast cancer setting. The two companies had previously announced in 2018 a separate research collaboration and license agreement for the discovery and development of drug candidates using Arvinas' PROTAC technology.

    Terms of the Collaboration

    The agreement is a worldwide co-development and co-commercialization collaboration. ARV-471 is wholly owned by Arvinas and under the financial terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will invest $350 million in Arvinas, receiving approximately 3.5 million newly issued shares of Arvinas common stock, priced at a 30% premium to the 30-day volume weighted average price on July 20, 2021. This represents an equity ownership stake by Pfizer of approximately 7%.

    Arvinas is also eligible to receive up to $400 million in approval milestones and up to $1 billion in commercial milestones, in addition to sharing profits on ARV-471 worldwide.

    Arvinas and Pfizer will jointly develop ARV-471 through a robust clinical program designed to position ARV-471 as an endocrine backbone therapy of choice across the breast cancer treatment paradigm, from the adjuvant setting through late-line metastatic disease.

    Closing of the equity investment agreement is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

    Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.

    Investor Conference Call Details

    A conference call and webcast will be held at 8:30 AM ET today with Arvinas and Pfizer Oncology executives to discuss the collaboration. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 6569429.

    Supporting materials for the conference call and webcast will be available here or on the Company's website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Arvinas Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the closing of the collaboration with Pfizer, the receipt of upfront, milestone and other payments under the Pfizer collaboration, the investment by Pfizer in Arvinas common stock in connection with the collaboration, the future development and potential marketing approval and commercialization of ARV-471, the potential benefits of the collaboration and the potential advantages and therapeutic benefits of ARV-471 and our other product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: the satisfaction or waiver of the conditions to the closing of the Pfizer collaboration and equity investment, each party's performance of its obligations under the collaboration, whether we and Pfizer will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-471 on our current timelines or at all and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    About IBRANCE® (palbociclib) 125 mg tablets and capsules

    IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

    The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.

    IMPORTANT IBRANCE® (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

    Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

    Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

    Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

    Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.

    Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

    The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

    The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

    Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

    The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

    The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

    Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

    Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

    For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis.

    About Pfizer Oncology

    At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Forward-Looking Statements

    The information contained in this release is as of July 22, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about ARV-471 and a global collaboration between Pfizer and Arvinas to develop and commercialize ARV-471, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for ARV-471 for any potential indications in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for ARV-471 in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ARV-471 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ARV-471; risks related to the satisfaction or waiver of the conditions to closing the transaction in the anticipated timeframe or at all; whether the collaboration between Pfizer and Arvinas will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com

    1 IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2019.

    2 Weinberg, RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.

    3 Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.

    Contacts

    Arvinas Investor Contact:

    Will O'Connor, Stern Investor Relations

    Arvinas Media Contact:

    Kirsten Owens, Arvinas Communications

    Pfizer Investor Contact:

    Chuck Triano

    +1 (212) 733-3901

    Pfizer Media Contact:

    Eamonn Nolan

    +1 (212) 733-4626



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  9. NEW HAVEN, Conn., June 07, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today joined state and local officials, fellow tenants, and community partners, in a groundbreaking ceremony for 101 College Street, a new 525,000-square-foot-building to be constructed as part of New Haven's Downtown Crossing revitalization project. Arvinas will lease three of the 10 floors at 101 College and this space will serve as the Company's headquarters beginning in 2024.

    "Today's groundbreaking ceremony marks an exciting milestone for Arvinas and will allow us to continue our rapid growth in the years ahead," said John Houston, Ph.D., President…

    NEW HAVEN, Conn., June 07, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today joined state and local officials, fellow tenants, and community partners, in a groundbreaking ceremony for 101 College Street, a new 525,000-square-foot-building to be constructed as part of New Haven's Downtown Crossing revitalization project. Arvinas will lease three of the 10 floors at 101 College and this space will serve as the Company's headquarters beginning in 2024.

    "Today's groundbreaking ceremony marks an exciting milestone for Arvinas and will allow us to continue our rapid growth in the years ahead," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "We are thrilled to contribute to the growing biopharmaceutical hub and development of the overall community."

    Construction of 101 College is scheduled to begin in the first half of 2021, and the Arvinas space is estimated to be complete and open for occupancy in 2024. Arvinas will occupy approximately 160,000-square-feet of lab and office accommodations. Arvinas will remain at its current location in Science Park until 101 College is available for occupancy.

    Construction of 101 College in the Downtown Crossing section of New Haven is an important step in the revitalization of the City's downtown neighborhoods. When complete, Downtown Crossing will create a connected, walkable community in New Haven's life sciences district, ease traffic, and bolster Connecticut's economy. Notably, the project will help connect Yale's medical and central campuses with world-class life science companies and hundreds of skilled employees. Downtown Crossing is funded by the U.S. Department of Transportation's TIGER II grant, the City of New Haven, and the State of Connecticut. Winstanley Enterprises, LLC., is the developer on this multi-tenant project.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties,. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/36f43554-3353-4335-8726-96ef1e345712

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

     



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  10. NEW HAVEN, Conn., June 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 announced that Ron Peck, M.D., Chief Medical Officer, and Sean Cassidy, Chief Financial Officer, will participate in a fireside chat at the 42nd Annual Goldman Sachs Global Healthcare Conference on Thursday, June 10 at 10:30 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients…

    NEW HAVEN, Conn., June 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 announced that Ron Peck, M.D., Chief Medical Officer, and Sean Cassidy, Chief Financial Officer, will participate in a fireside chat at the 42nd Annual Goldman Sachs Global Healthcare Conference on Thursday, June 10 at 10:30 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  11. NEW HAVEN, Conn., May 20, 2021 (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 John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Tuesday, May 25 at 10:00 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives…

    NEW HAVEN, Conn., May 20, 2021 (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 John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Tuesday, May 25 at 10:00 a.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

     



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  12. NEW HAVEN, Conn., May 04, 2021 (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 it will be leasing three of the 10 floors at 101 College Street in New Haven, Conn. Winstanley Enterprises, LLC., is the developer on this multi-tenant project.

    The 101 College Street building is part of the Downtown Crossing revitalization project near the Yale School of Medicine and Yale-New Haven Hospital. Construction of 101 College is scheduled to begin in the first half of 2021, and the Arvinas space is estimated to be complete and open for occupancy in 2024. Arvinas will occupy approximately 160,000-square-feet of lab and office…

    NEW HAVEN, Conn., May 04, 2021 (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 it will be leasing three of the 10 floors at 101 College Street in New Haven, Conn. Winstanley Enterprises, LLC., is the developer on this multi-tenant project.

    The 101 College Street building is part of the Downtown Crossing revitalization project near the Yale School of Medicine and Yale-New Haven Hospital. Construction of 101 College is scheduled to begin in the first half of 2021, and the Arvinas space is estimated to be complete and open for occupancy in 2024. Arvinas will occupy approximately 160,000-square-feet of lab and office accommodations. Arvinas will remain at its current location in Science Park until 101 College is available for occupancy.

    "Arvinas has experienced significant growth over the last several years as we have led the development of a completely new treatment approach for cancers and other difficult-to-treat diseases," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "As a company incubated out of Yale, our commitment to New Haven is strong. We're proud to continue to be a part of this rapidly growing biopharmaceutical hub and contribute to the continued development of the downtown area."

    "The City of New Haven is thrilled that Arvinas has selected 101 College Street for their future headquarters location. This is an exciting milestone for Arvinas, New Haven, and Connecticut," said New Haven Mayor Justin Elicker. "New Haven has a lot to offer, and we look forward to continuing the progress of the Downtown Crossing project."

    "Arvinas' decision to join 101 College Street is clear reinforcement of Connecticut's commitment to the bioscience sector," said Governor Ned Lamont. "This is another critical step in realizing New Haven and Connecticut's shared vision for the Downtown Crossing project – an important revitalization effort and economic investment."

    Construction of 101 College in the Downtown Crossing section of New Haven is an important step in the revitalization of the City's downtown neighborhoods. When complete, Downtown Crossing will create a connected, walkable community in New Haven's life sciences district, ease traffic, and bolster Connecticut's economy. Notably, the project will help connect Yale's medical and central campuses with world-class life science companies and hundreds of skilled employees. Downtown Crossing is funded by the U.S. Department of Transportation's TIGER II grant, the City of New Haven, and the State of Connecticut.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates,and the potential advantages and therapeutic potential of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for our current product candidates, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

    Aerial view of 101 College Street in the Downtown Crossing section of New Haven, Conn. is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6a9f2066-a2da-4339-9797-50028fdf0b17.

    Street view of 101 College Street in the Downtown Crossing section of New Haven, Conn. is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8c683120-1cd1-4b03-b8b1-5024792ed164.

    A view of the outdoor courtyard and sidewalk area adjacent to 101 College Street is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fd2d2c23-bf2e-45e5-aa2c-a612e233dffd.



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  13. NEW HAVEN, Conn., May 04, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    "Last quarter we reinforced our leadership position in the targeted protein degradation space by sharing the discovery and chemical structures of ARV-110 and ARV-471 at the American Association for Cancer Research (AACR) Annual Meeting, the first such disclosure of our clinical-stage PROTAC degraders," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "We look forward to further demonstrating the potential of our PROTAC…

    NEW HAVEN, Conn., May 04, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    "Last quarter we reinforced our leadership position in the targeted protein degradation space by sharing the discovery and chemical structures of ARV-110 and ARV-471 at the American Association for Cancer Research (AACR) Annual Meeting, the first such disclosure of our clinical-stage PROTAC degraders," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "We look forward to further demonstrating the potential of our PROTAC platform to change the lives of patients with few or no therapeutic options."

    Business Highlights and Recent Developments

    • Presented preclinical data describing the discovery of Arvinas' two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures at AACR

    Anticipated Milestones and Expectations

    ARV-471

    • Completion of the Phase 1 dose escalation (1H21)
    • Presentation of completed Phase 1 dose escalation data (2H21)
    • Interim review of safety and dose finding data from the Phase 1b trial in combination with Ibrance® (palbociclib) (2H21)
    • Initiation of a window of opportunity study in early breast cancer (2H21)
    • Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21)

    ARV-110

    • Completion of the Phase 1 dose escalation (1H21)
    • Presentation of completed Phase 1 dose escalation data (2H21)
    • Presentation of interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
    • Initiation of combination trial(s) with standard(s)-of-care (2021)

    Other Clinical Milestones

    • Initiation of first-in-human study of ARV-766, an androgen receptor (AR) degrader with a differentiated profile from ARV-110, in patients with metastatic castration-resistant prostate cancer (1H21)

    Financial Guidance

    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2024.

    First Quarter Financial Results

    Cash, Cash Equivalents and Marketable Securities Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $651.3 million as compared with $688.5 million as of December 31, 2020. The decrease primarily related to cash used to fund operations of $43.9 million, cash used to purchase fixed assets and leasehold improvements of $1.0 million and unrealized losses of $0.8 million, partially off-set by proceeds from two collaborators of $4.0 million and proceeds from the exercise of stock options of $4.5 million.

    Research and Development Expenses: Research and development expenses were $34.9 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in research and development expenses for the quarter of $13.2 million primarily related to Arvinas' continued investment in its platform, exploratory and lead optimization programs of $8.3 million, its AR program of $1.5 million and estrogen receptor program (ER) of $3.4 million.

    General and Administrative Expenses: General and administrative expenses were $12.3 million for the quarter ended March 31, 2021 as compared with $7.9 million for the quarter ended March 31, 2020. The increase in general and administrative expenses for the quarter of $4.4 million related to an increase of $3.6 million in personnel and facility related costs, including $1.8 million related to stock compensation expense, and insurance, taxes and professional fees of $0.8 million.

    Revenues: Revenues were $5.5 million for the quarter ended March 31, 2021 as compared with $6.2 million for the quarter ended March 31, 2020 and was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The decrease in collaboration revenue of $0.7 million for the quarter was primarily related to a collaborator adding new targets that extended the period of revenue recognition for that collaboration agreement.   

    Net Loss: Net loss was $41.0 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in net loss for the quarter ended March 31, 2021 of $19.3 million primarily related to Arvinas' continued investment in its platform, exploratory and lead optimization programs, its AR program, its ER program, and an increase in general and administrative costs.

    About ARV-110

    ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About ARV-766

    ARV-766 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

    ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, including the timing of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471 or conduct a Phase 1 clinical trial for ARV-766, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
       
     Three Months Ended March 31,
      2021   2020 
    Revenue$5,539,365  $6,239,628 
    Operating expenses:       
    Research and development 34,866,882   21,726,686 
    General and administrative 12,318,713   7,925,005 
    Total operating expenses 47,185,595   29,651,691 
    Loss from operations (41,646,230)  (23,412,063)
    Interest and other income 681,939   1,672,892 
    Net loss (40,964,291)  (21,739,171)
    Net loss per common share, basic and diluted (0.84)  (0.56)
    Weighted average common shares outstanding, basic and diluted 48,621,663   38,548,483 
       





    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
        
     March 31,
      2021   2020 
            
    Assets   
    Current assets:   
    Cash and cash equivalents$346,068,406  $588,373,232 
    Marketable securities 305,203,086   100,157,618 
    Account receivable    1,000,000 
    Other receivables 5,175,378   7,443,654 
    Prepaid expenses and other current assets 8,209,888   6,113,122 
    Total current assets 664,656,758   703,087,626 
    Property, equipment and leasehold improvements, net 12,210,324   12,259,515 
    Operating lease right of use assets 4,876,584   1,992,669 
    Other assets 28,777   28,777 
    Total assets$681,772,443  $717,368,587 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$9,002,938  $7,121,879 
    Accrued expenses 8,001,201   18,859,840 
    Deferred revenue 22,150,861   22,150,861 
    Current portion of operating lease liabilities 1,216,914   952,840 
    Total current liabilities 40,371,914   49,085,420 
    Deferred revenue 20,400,518   22,938,233 
    Long term debt, net of current portion 2,000,000   2,000,000 
    Operating lease liabilities 3,701,991   1,087,422 
    Total liabilities 66,474,423   75,111,075 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock, $0.001 par value, 48,785,692 and 48,455,741 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 48,786   48,455 
    Accumulated deficit (532,853,201)  (491,888,910)
    Additional paid-in capital 1,148,345,190   1,133,537,171 
    Accumulated other comprehensive income (242,755)  560,796 
    Total stockholders' equity 615,298,020   642,257,512 
    Total liabilities and stockholders' equity$681,772,443  $717,368,587 
        


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  14. NEW HAVEN, Conn., April 05, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021. These presentations will describe the discovery of Arvinas' two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

    Details for the presentations are as follows:

    Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC® for the treatment of men with metastatic castration resistant prostate…

    NEW HAVEN, Conn., April 05, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021. These presentations will describe the discovery of Arvinas' two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

    Details for the presentations are as follows:

    Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC® for the treatment of men with metastatic castration resistant prostate cancer

    Date and Time: April 11, 2021 from 2:05 PM - 2:15 PM ET

    Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas

    Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

    Title: The discovery of ARV-471, an orally bioavailable estrogen receptor degrading PROTAC® for the treatment of patients with breast cancer

    Date and Time: April 11, 2021 from 2:20 PM - 2:30 PM ET

    Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas

    Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

    Abstracts will be available for registered attendees on the AACR website beginning on April 9, 2021.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  15. NEW HAVEN, Conn., March 10, 2021 (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 it will participate in two upcoming virtual investor conferences. John Houston, Ph.D., President and Chief Executive Officer, will participate in panel discussions at both conferences.

    • Guggenheim Targeted Protein Degradation Day panel discussion on Tuesday, March 16, 2021 at 10:30 a.m. ET
    • 33rd Annual Roth Conference panel discussion on Wednesday, March 17, 2021 at 5:00 p.m. ET

    A live audio webcast of each panel will be available on Arvinas' website at www.arvinas.com. A replay of each webcast will be archived on Arvinas' website for…

    NEW HAVEN, Conn., March 10, 2021 (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 it will participate in two upcoming virtual investor conferences. John Houston, Ph.D., President and Chief Executive Officer, will participate in panel discussions at both conferences.

    • Guggenheim Targeted Protein Degradation Day panel discussion on Tuesday, March 16, 2021 at 10:30 a.m. ET
    • 33rd Annual Roth Conference panel discussion on Wednesday, March 17, 2021 at 5:00 p.m. ET

    A live audio webcast of each panel will be available on Arvinas' website at www.arvinas.com. A replay of each webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  16. NEW HAVEN, Conn., March 01, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    "2020 was a breakthrough year for Arvinas and for the patients we aim to serve, as we reported clear signals of efficacy in both of our clinical-stage programs. These data provided further validation that our approach to protein degradation could potentially change the lives of patients with few or no therapeutic options," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "Despite the unprecedented circumstances…

    NEW HAVEN, Conn., March 01, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    "2020 was a breakthrough year for Arvinas and for the patients we aim to serve, as we reported clear signals of efficacy in both of our clinical-stage programs. These data provided further validation that our approach to protein degradation could potentially change the lives of patients with few or no therapeutic options," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "Despite the unprecedented circumstances of a pandemic, our clinical trials and preclinical research continued to deliver, and we enter 2021 well positioned to extend our success and progress our programs in oncology and neurodegeneration."

    Business Highlights and Recent Developments

    • Presented interim Phase 1 data for ARV-471 showing potential for best-in-class safety and tolerability, estrogen receptor (ER) degradation greater than that previously reported for the current standard of care agent (fulvestrant), and a robust efficacy signal in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer
    • Presented data from the ongoing dose escalation portion of the Phase 1/2 trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC), providing additional evidence of anti-tumor activity and patient benefit, including a prostate specific antigen reduction ≥50% (PSA50) in 2 of 5 (40%) in a molecularly defined patient population
    • Closed an underwritten public offering of 6,571,428 shares of common stock at a public offering price of $70.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Arvinas received net proceeds of $431.9 million, after deducting underwriting discounts and commissions and offering expenses
    • Initiated the ARDENT Phase 2 dose expansion study of ARV-110 (Dose: 420 mg daily)
    • Initiated the VERITAC Phase 2 dose expansion study of ARV-471 (Dose: 200 mg daily)
    • Initiated a Phase 1b trial of ARV-471 in combination with Ibrance® (palbociclib)

    Anticipated Milestones and Expectations

    ARV-471

    • Completion of the Phase 1 dose escalation (1H21)
    • Presentation of completed Phase 1 dose escalation data (2H21)
    • Announcement of safety data from the Phase 1b trial in combination with Ibrance® (palbociclib) (2H21)
    • Initiation of a window of opportunity study in adjuvant breast cancer (2H21)
    • Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21)

    ARV-110

    • Completion of the Phase 1 dose escalation (1H21)
    • Presentation of completed Phase 1 dose escalation data (2H21)
    • Announcement of interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
    • Initiation of combination trial(s) with standards-of-care (2021)

    Other Clinical Milestones

    • Initiation of first-in-human study of ARV-766, an androgen receptor (AR) degrader with a differentiated profile from ARV-110, in patients with metastatic castration-resistant prostate cancer (1H21)

    Financial Guidance

    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2024.

    Full Year and Fourth Quarter Financial Results

    Cash, Cash Equivalents and Marketable Securities Position: As of December 31, 2020, cash, cash equivalents and marketable securities were $688.5 million as compared with $280.9 million as of December 31, 2019. The increase primarily related to net proceeds from the issuance of common stock and proceeds from the exercise of stock options of $504.7 million, proceeds from two collaborators of $7.4 million, partially offset by cash used to fund operations of approximately $98.1 million and cash used to purchase fixed assets and leasehold improvements of $6.4 million.

    Research and Development Expenses: Research and development expenses were $108.4 million and $33.2 million for the year and quarter ended December 31, 2020, respectively, as compared with $67.2 million and $20.4 million for the year and quarter ended December 31, 2019, respectively. The increase in research and development expenses for the year of $41.2 million primarily related to Arvinas' continued investment in its wholly owned platform, exploratory and lead optimization programs of $17.6 million, its androgen receptor (AR) program of $12.3 million and estrogen receptor program (ER) of $11.3 million. The increase in research and development expense for the quarter of $12.8 million primarily related to Arvinas' continued investment in its wholly owned platform, exploratory and lead optimization programs of $5.1 million, its AR program of $4.8 million and ER program of $2.9 million.

    General and Administrative Expenses: General and administrative expenses were $38.3 million and $12.2 million for the year and quarter ended December 31, 2020, respectively, as compared with $27.3 million and $7.3 million for the year and quarter ended December 31, 2019, respectively. The increase in general and administrative expenses for the year of $11.0 million related to an increase of $9.6 million in personnel and facility related costs, including $4.8 million related to stock compensation expense, and insurance, taxes and professional fees of $1.4 million. The increase in general and administrative expenses for the quarter of $5.0 million primarily related to an increase of $2.9 in personnel and facility cost, including $1.4 million related to stock compensation expense and $1.7 million of legal and other professional services.

    Revenues: Revenues were $21.8 million and $2.2 million for the year and quarter ended December 31, 2020, respectively, as compared with $43.0 million and $4.9 million for the year and quarter ended December 31, 2019, respectively. Revenue for the year ended December 31, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC® technology in agricultural applications (the Joint Venture). The remaining collaboration revenue of $18.3 million and revenue of $4.9 million for the year and quarter ended December 31, 2019, respectively, was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The increase in collaboration revenue of $3.5 million for the year was primarily related to the Bayer agreement having only a partial year of revenue recognized in 2019 and an increase in activities related to the Pfizer agreement. The decrease in collaboration revenue of $2.7 million in the quarter primarily related to a collaborator adding new targets that extended the period of revenue recognition for the collaboration agreement.   

    Loss from Equity Method Investment: Loss from equity method investment for the year ended December 31, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture's expensing the values associated with the contributed intellectual property from the Joint Venture partners.

    Net Loss: Net loss was $119.3 million and $41.5 million for the year and quarter ended December 31, 2020, respectively, as compared with $70.3 million and $21.0 million for the year and quarter ended December 31, 2019, respectively. The increase in net loss for the year and quarter ended December 31, 2020 of $49.0 million and $20.5 million, respectively, primarily related to Arvinas' continued investment in its platform, exploratory and lead optimization programs, its AR program, its ER program, and an increase in general and administrative infrastructure costs.

    About ARV-110

    ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, including the timing of initiation or completion of or availability of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, conduct a Phase 1 clinical trial of ARV-766 complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications





    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
          
     Quarter Ended December 31, Year Ended December 31,
      2020  2019   2020  2019 
    Revenue$2,217,692 $4,893,273  $21,801,777 $42,976,478 
    Operating expenses:     
    Research and development 33,200,159  20,414,783   108,355,853  67,193,830 
    General and administrative 12,230,997  7,268,390   38,303,401  27,307,162 
    Total operating expenses 45,431,156  27,683,173   146,659,254  94,500,992 
    Loss from operations (43,213,464) (22,789,900)  (124,857,477) (51,524,514)
    Interest and other income 1,666,976  1,742,184   5,525,413  5,907,287 
    Loss from equity method investment        (24,675,000)
    Net loss (41,546,488) (21,047,716)  (119,332,064) (70,292,227)
    Net loss per common share, basic and diluted (0.99)$(0.56)  (3.02) (2.13)
    Weighted average common shares outstanding, basic and diluted 41,767,980  37,338,484   39,534,497  32,927,697 
          



    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
        
     December 31,
      2020   2019 
    Assets   
    Current assets:   
    Cash and cash equivalents$588,373,232  $9,211,057 
    Marketable securities 100,157,618   271,661,456 
    Account receivable 1,000,000    
    Other receivables 7,443,654   6,280,828 
    Prepaid expenses and other current assets 6,113,122   3,727,294 
    Total current assets 703,087,626   290,880,635 
    Property, equipment and leasehold improvements, net 12,259,515   8,455,411 
    Operating lease right of use assets 1,992,669   2,278,623 
    Other assets 28,777   26,757 
    Total assets$717,368,587  $301,641,426 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$7,121,879  $4,556,827 
    Accrued expenses 18,859,840   7,602,904 
    Deferred revenue 22,150,861   19,979,525 
    Current portion of operating lease liabilities 952,840   673,896 
    Total current liabilities 49,085,420   32,813,152 
    Deferred revenue 22,938,233   38,427,882 
    Long term debt, net of current portion 2,000,000   2,000,000 
    Operating lease liabilities 1,087,422   1,714,111 
    Total liabilities 75,111,075   74,955,145 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock, $0.001 par value, 48,455,741 and 38,461,353 shares issued and outstanding as of December 31, 2020 and 2019, respectively 48,455   38,461 
    Accumulated deficit (491,888,910)  (372,556,846)
    Additional paid-in capital 1,133,537,171   599,097,090 
    Accumulated other comprehensive income 560,796   107,576 
    Total stockholders' equity 642,257,512   226,686,281 
    Total liabilities and stockholders' equity$717,368,587  $301,641,426 
        

     

     



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  17. NEW HAVEN, Conn., Feb. 08, 2021 (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 John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks: 2021 Oncology Day on Thursday, February 11 at 4:30 p.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving…

    NEW HAVEN, Conn., Feb. 08, 2021 (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 John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks: 2021 Oncology Day on Thursday, February 11 at 4:30 p.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  18. NEW HAVEN, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced that the underwriters of its previously announced underwritten public offering of common stock, which closed on December 18, 2020, have exercised in full their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. After giving effect to the sale of 857,142 additional shares of common stock in the option closing, the total number of shares of common stock sold by Arvinas in the offering increased to 6,571,428 shares, which resulted…

    NEW HAVEN, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced that the underwriters of its previously announced underwritten public offering of common stock, which closed on December 18, 2020, have exercised in full their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. After giving effect to the sale of 857,142 additional shares of common stock in the option closing, the total number of shares of common stock sold by Arvinas in the offering increased to 6,571,428 shares, which resulted in aggregate net proceeds of approximately $431.9 million.   All of the shares were offered by Arvinas.

    Goldman Sachs & Co. LLC and Piper Sandler & Co. acted as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BMO Capital Markets acted as co-managers for the offering.

    An automatically effective shelf registration statement relating to the shares of common stock offered in the public offering was previously filed with the Securities and Exchange Commission. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at .

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Arvinas, Inc.

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    Investors:        

    Will O'Connor, Stern Investor Relations

    Media:

    Kirsten Owens, Arvinas Communications



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  19. NEW HAVEN, Conn., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced the pricing of an underwritten public offering of 5,714,286 shares of its common stock at a price of $70.00 per share, before underwriting discounts and commissions. In addition, Arvinas has granted the underwriters an option for a period of 30 days to purchase up to an additional 857,142 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arvinas.

    Goldman Sachs & Co. LLC and Piper Sandler & Co. are acting as joint…

    NEW HAVEN, Conn., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced the pricing of an underwritten public offering of 5,714,286 shares of its common stock at a price of $70.00 per share, before underwriting discounts and commissions. In addition, Arvinas has granted the underwriters an option for a period of 30 days to purchase up to an additional 857,142 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arvinas.

    Goldman Sachs & Co. LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BMO Capital Markets are acting as co-managers for the offering. The offering is expected to close on or about December 18, 2020, subject to customary closing conditions.

    An automatically effective shelf registration statement on Form S-3 (File No. 333-251326) relating to the shares of common stock offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") on December 14, 2020. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at .

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Arvinas, Inc.

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the proposed public offering, including the closing of the public offering. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to satisfaction of customary closing conditions related to the public offering, whether we will be able to conduct, complete and receive results from clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the SEC. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Investors:

    Will O'Connor, Stern Investor Relations

    Media:

    Kirsten Owens, Arvinas Communications



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  20. NEW HAVEN, Conn., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced that it is commencing an underwritten public offering of $250.0 million of its common stock. In addition, Arvinas intends to grant the underwriters an option for a period of 30 days to purchase up to an additional $37.5 million of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by Arvinas.

    Goldman Sachs & Co. LLC…

    NEW HAVEN, Conn., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced that it is commencing an underwritten public offering of $250.0 million of its common stock. In addition, Arvinas intends to grant the underwriters an option for a period of 30 days to purchase up to an additional $37.5 million of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by Arvinas.

    Goldman Sachs & Co. LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

    An automatically effective shelf registration statement on Form S-3 relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") on December 14, 2020. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering is being filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at .

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Arvinas, Inc.

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the proposed public offering, including the completion of the public offering on the anticipated terms, or at all. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to market and other financial conditions, satisfaction of customary closing conditions related to the proposed public offering, whether we will be able to conduct, complete and receive results from clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the SEC. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Investors:        

    Will O'Connor, Stern Investor Relations

    Media:        

    Kirsten Owens, Arvinas Communications



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  21. – ARV-471 demonstrates evidence of anti-tumor activity, and potential for best-in-class safety, and estrogen receptor (ER) degradation profile and robust efficacy signals in a heavily pretreated patient population –

    – Initiation of a combination trial of ARV-471 and Ibrance® (palbociclib) expected this month; three additional trials of ARV-471 in patients with breast cancer expected to begin in 2021 –

    – ARV-110 continues to demonstrate a favorable safety profile, tolerability, and anti-tumor activity in a heavily pretreated patient population as Phase 1 dose escalation continues in parallel with the ARDENT Phase 2 expansion –

    – The ARDENT Phase 2 expansion trial for ARV-110 is designed to evaluate the potential for accelerated approval in

    – ARV-471 demonstrates evidence of anti-tumor activity, and potential for best-in-class safety, and estrogen receptor (ER) degradation profile and robust efficacy signals in a heavily pretreated patient population –

    – Initiation of a combination trial of ARV-471 and Ibrance® (palbociclib) expected this month; three additional trials of ARV-471 in patients with breast cancer expected to begin in 2021 –

    – ARV-110 continues to demonstrate a favorable safety profile, tolerability, and anti-tumor activity in a heavily pretreated patient population as Phase 1 dose escalation continues in parallel with the ARDENT Phase 2 expansion –

    – The ARDENT Phase 2 expansion trial for ARV-110 is designed to evaluate the potential for accelerated approval in a molecularly defined population and broader approval in earlier mCRPC –

    NEW HAVEN, Conn., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation using its PROTAC® Discovery Engine, today announced clinical program updates for its PROTAC® protein degraders ARV-471 and ARV-110. For ARV-471, interim Phase 1 data show potential for best-in-class safety and tolerability, estrogen receptor (ER) degradation superior to that previously reported for the current standard of care agent (fulvestrant), and robust efficacy signals in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer. The efficacy signals include one Response Evaluation Criteria in Solid Tumors (RECIST) confirmed partial response (PR), two additional patients with unconfirmed PRs, and a clinical benefit rate (CBR) of 42%. For ARV-110, the ongoing dose escalation portion of the Phase 1/2 trial in men with metastatic castration-resistant prostate cancer (mCRPC) has provided additional evidence of anti-tumor activity and patient benefit, including a prostate specific antigen reduction of more than 50% (PSA50) rate of 40% in a molecularly defined patient population. Arvinas has initiated a Phase 2 dose expansion to explore a two-pronged development strategy, including the potential for accelerated approval in molecularly defined, late-line patients, and broader development in less-heavily pretreated mCRPC patients with fewer androgen receptor (AR)-independent mechanisms of tumor resistance.

    Both ARV-471 and ARV-110 have been well tolerated, neither has reached a maximum tolerated dose, and the Phase 1 dose escalation trials for both programs continue. A Phase 1b combination trial of ARV-471 and Ibrance® (palbociclib) is expected to begin in December 2020, and a Phase 2 expansion cohort for ARV-471 is scheduled to begin in the first half of 2021.

    "After initiating our clinical efforts just last year, we now have what we believe are clear signals of efficacy in both of our clinical-stage development programs," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "The clinical benefits we've seen in both patient populations, including tumor shrinkage and low incidence of adverse effects, are compelling and reinforce our belief that our PROTAC protein degraders could dramatically change the lives of patients who have few or no therapeutic options."

    "Based on data to date, we believe ARV-471 is the most promising ER-targeting therapy in the clinic, showing early signs of efficacy, a favorable tolerability profile, and better ER degradation than that previously reported for fulvestrant, the current standard of care," said Ron Peck, Ph.D., Chief Medical Officer at Arvinas. "It is exciting to see that ARV-110 continues to be active and well tolerated in what we believe is the most heavily pretreated patient population that has ever been studied with an AR-directed therapy. Our recently initiated ARDENT Phase 2 cohort expansion is specifically designed to investigate the potential of a precision medicine approach in molecularly defined, late-line patients with few available treatment options, while also fully characterizing the safety and activity of ARV-110 in earlier line patients irrespective of molecular profile, setting ARV-110 on a potential two-pronged registrational path."

    ARV-471 Clinical Update

    As of the data cut-off date of November 11, 2020, 21 adult patients with locally advanced or metastatic ER+/HER2- breast cancer completed at least one treatment cycle with ARV-471 (orally, once-daily) in the Phase 1 clinical trial. 100% of these patients were previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor, 71% of patients received prior fulvestrant, and 23% of patients were pretreated with investigational selective estrogen receptor degraders (SERDs). Overall, patients had a median of five prior therapies.

    In metastatic breast cancer, prior treatment with CDK4/6 inhibitors predicts high tumor ER-independence, rendering ER-targeting therapies ineffective. However, one patient in the ARV-471 trial had a confirmed PR with a 51% reduction in target lesion size as assessed by RECIST. Two additional patients had unconfirmed PRs and one additional patient demonstrated stable disease with >50% target lesion shrinkage. For evaluation of CBR, 12 patients had sufficient follow-up to be included. Five of 12 patients (42%) achieved CBR (CBR defined as PRs + complete responses + stable disease at 6 months). Three of these five patients had previously received fulvestrant, and another was treated with two investigational SERDs.

    ARV-471 has been well tolerated at all dose levels, as of the data cut-off date. The most common treatment-related Grade 1-2 adverse events were nausea (24%), arthralgia (19%), fatigue (19%), and decreased appetite (14%). None of these led to discontinuation or dose reduction of ARV-471. No patients reported treatment-related Grade 3 of 4 adverse events, and no dose-limiting toxicities (DLTs) have been reported. A maximum tolerated dose (MTD) has not been reached and dose escalation continues.

    The plasma exposures of ARV-471 have been dose proportional up to and including 360 mg orally once daily and have substantially exceeded Arvinas' predicted thresholds of efficacy based on preclinical studies. The estimated half-life of ARV-471 is 28 hours, supporting a once-daily schedule of administration. Analysis of five paired tumor biopsies at doses up to 120 mg provide compelling proof of mechanism for ARV-471, which has demonstrated ER degradation up to 90% (average of 62%) at those doses, while dose escalation continues.

    The combined profile of ARV-471, including efficacy signals in a highly refractory population, excellent tolerability profile, and high levels of ER degradation, support a potential best-in-class ER-targeting therapy.

    A Phase 2 dose expansion of ARV-471 is expected to begin in the first half of 2021. Arvinas also expects to initiate a Phase 1b cohort expansion of ARV-471 in combination with Ibrance® (palbociclib) in December 2020. This trial will evaluate the safety and tolerability of ARV-471 in combination with palbociclib and seek to identify a recommended combination dose. Arvinas expects to begin two additional studies of ARV-471 in the second half of 2021: a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer, and a window of opportunity study in adjuvant breast cancer. The combined data from these studies will inform Arvinas' global development strategy and path forward toward the goal for ARV-471 to become the leading endocrine therapy in ER+/HER2- breast cancer.

    ARV-110 Clinical Update

    In the Phase 1 clinical trial in men with mCRPC, ARV-110 continues to show promising activity in a very late-line population, with PSA reductions >50% observed at doses greater than 280 mg, the last reported cohort.

    In the dose escalation, ARV-110 exposures have risen dose proportionally, and at 420 mg oral daily dosing, exposures in nearly all patients have surpassed a threshold associated with tumor responses with ARV-110 in enzalutamide-resistant preclinical models of prostate cancer. Increases in exposure are associated with increased frequency of PSA reductions.

    In the Phase 1 dose escalation trial, 76% of patients had been treated with prior chemotherapy, and 82% previously received both abiraterone and enzalutamide. Patients had a median of five prior lines of therapy. Multiple lines of therapy in nonmetastatic and metastatic castrate resistant prostate cancer are associated with a decreased responsiveness to AR-directed therapies and an increase in tumor heterogeneity, including in genetic mutations, which reduce the tumor's dependence on the AR signaling axis. Genetic profiling of trial patient tumors has led to significant learnings about the ARV-110 Phase 1 patient population, especially regarding genetic variability. 84% of patients in the trial have non-AR gene mutations, and as such, they would not be expected to respond. In addition, rates of specific AR mutations have been found to be higher than reported in publications that have characterized prevalence of AR mutations in men with mCRPC.

    Despite the highly heterogeneous nature of the Phase 1 patient population, Arvinas has identified a molecularly defined, late-line population with a particularly strong response to ARV-110. Two of five patients (40%) with T878 or H875 mutations in AR had PSA reductions >50%, including one patient with a confirmed PR by RECIST and tumor size reduction of 80%.

    In addition, two of 15 patients (13%) with wild-type AR also had PSA reductions >50%, representing activity in a broader patient population. In the full group of patients with exposures above the minimum threshold Arvinas predicted to be efficacious by preclinical studies, four of 28 (14%) had PSA reductions >50%. These PSA50 rates are higher than would be expected from approved AR-directed therapies in such late-line patients. Specifically, PSA50 response rates from standard-of-care AR-directed therapies generally decrease to 8-15% in mCRPC patients with fewer prior therapies than the patients in the ARV-110 trial.

    The dual signals of ARV-110 activity in a molecularly defined population (T878/H875) and in wild-type patients supports Arvinas' two-pronged strategy for ARV-110 development and suggest a robust opportunity to address unmet need in patients with mCRPC.

    A daily dose of 420 mg was selected as a Phase 2 expansion dose based on pharmacokinetics, safety profile, and the activity signals in both T878/H875 and wild-type patients. In the ARDENT Phase 2 expansion, T878/H875 patients will be enriched in a subgroup to ensure sufficient patient numbers to support the potential for accelerated approval in this population. A separate subgroup will enrich for less-pretreated patients (i.e., no prior chemotherapy and with only one previous second-generation AR-directed therapy, such as enzalutamide or abiraterone), to ensure sufficient numbers of patients whose tumors are expected to be more AR-dependent, less genetically complex, and more responsive to ARV-110.

    The ARDENT Phase 2 expansion (N = ~100) began enrolling in October 2020, and Arvinas expects to provide interim data from the trial in the second half of 2021. In 2021, Arvinas also expects to begin at least one Phase 1b combination trial with a standard-of-care prostate cancer therapy and provide complete data from the Phase 1 dose escalation.

    Anticipated 2020/2021 Milestones

    ARV-471

    • Initiation of a Phase 1b trial in combination with Ibrance® (palbociclib) (December 2020)
    • Initiation of a Phase 2 dose expansion (1H21)
    • Completion of the Phase 1 dose escalation (1H21)
    • Safety data from the Phase 1b trial in combination with Ibrance® (palbociclib) (2H21)
    • Initiation of a window of opportunity study in adjuvant breast cancer (2H21)
    • Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21)

    ARV-110

    • Completion of the Phase 1 dose escalation (1H21)
    • Interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
    • Initiation of combination trial(s) with standards-of-care (2021)

    Other clinical milestones

    • First-in-human start for ARV-766, an AR degrader with a different profile from ARV-110 (1H21)

    Arvinas Webcast Investor Meeting

    Arvinas will host a conference call and webcast at 8:00 AM ET on Monday, December 14, 2020 to discuss these data. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 9681734. A live webcast presentation will be available here or on the Company's website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

    About ARV-110

    ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates ARV-110, ARV-471, ARV-766, and other candidates in our pipeline, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, our planned Phase 1b combination trial for ARV-471, our planned Phase 1b combination trials for ARV-110, the plans for presentation of data from our Phase 1/2 clinical trials for ARV-110 and ARV-471, the planned first-in-human start for ARV-766,and the potential advantages and therapeutic potential of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471 and Phase 1b combination trials for ARV-110 or ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

     



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  22. – Event to be webcast live on Monday, December 14, 2020 at 8:00 a.m. ET –

    NEW HAVEN, Conn., Dec. 11, 2020 (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 it will host a live webcast presentation on Monday, December 14, 2020 at 8:00 a.m. ET to provide clinical program updates for its PROTAC® protein degraders ARV-471 and ARV-110. The presentation will include updates from the Phase 1 dose escalation studies of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer and ARV-110 in men with metastatic castrate-resistant prostate cancer. The event will also include an…

    – Event to be webcast live on Monday, December 14, 2020 at 8:00 a.m. ET –

    NEW HAVEN, Conn., Dec. 11, 2020 (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 it will host a live webcast presentation on Monday, December 14, 2020 at 8:00 a.m. ET to provide clinical program updates for its PROTAC® protein degraders ARV-471 and ARV-110. The presentation will include updates from the Phase 1 dose escalation studies of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer and ARV-110 in men with metastatic castrate-resistant prostate cancer. The event will also include an overview of the recently initiated Phase 2 dose expansion study for ARV-110.

    The live webcast presentation will be available here or on the Company's website at www.arvinas.com under Events + Presentations. To access the event via dial-in, please dial (844) 467-7654 (domestic) or (602) 563-8497 (international) and refer to conference ID 9681734. A replay of the webcast will be archived on the Arvinas website following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

     

    Media

    Kirsten Owens, Arvinas Communications

     



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  23. NEW HAVEN, Conn., Nov. 25, 2020 (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 participate in two upcoming virtual investor conferences:

    Piper Sandler 32nd Annual Virtual Healthcare Conference on Tuesday, December 1, 2020. A pre-recorded fireside chat held with John Houston, Ph.D., President and Chief Executive Officer, and Ian Taylor, Ph.D., Chief Scientific Officer, is available here and on the Events + Presentations section of the Company's website.

    3rd Annual Evercore ISI HealthCONx Virtual Conference on Thursday, December 3, 2020. Ian Taylor, Ph.D., Chief Scientific Officer, and Randy Teel…

    NEW HAVEN, Conn., Nov. 25, 2020 (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 participate in two upcoming virtual investor conferences:

    Piper Sandler 32nd Annual Virtual Healthcare Conference on Tuesday, December 1, 2020. A pre-recorded fireside chat held with John Houston, Ph.D., President and Chief Executive Officer, and Ian Taylor, Ph.D., Chief Scientific Officer, is available here and on the Events + Presentations section of the Company's website.

    3rd Annual Evercore ISI HealthCONx Virtual Conference on Thursday, December 3, 2020. Ian Taylor, Ph.D., Chief Scientific Officer, and Randy Teel, Ph.D., Vice President of Corporate Development, will participate in a fireside chat at 8:50 a.m. ET. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company's website.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications



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  24. First patient dosed in Phase 2 dose expansion cohort of ARV-110 trial

    – Dose escalation for Phase 1/2 clinical trials of ARV-110 and ARV-471 continues; program updates planned for December 2020

    Arvinas and Pfizer enter collaboration and supply agreement; initiation of Phase 1b combination of ARV-471 and Ibrance® expected in the fourth quarter of 2020

    NEW HAVEN, Conn., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    "Beginning the Phase 2 portion of the ARV-110 clinical trial marks another significant…

    First patient dosed in Phase 2 dose expansion cohort of ARV-110 trial

    – Dose escalation for Phase 1/2 clinical trials of ARV-110 and ARV-471 continues; program updates planned for December 2020

    Arvinas and Pfizer enter collaboration and supply agreement; initiation of Phase 1b combination of ARV-471 and Ibrance® expected in the fourth quarter of 2020

    NEW HAVEN, Conn., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    "Beginning the Phase 2 portion of the ARV-110 clinical trial marks another significant milestone for Arvinas," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "Together with the expected initiation of a cohort expansion of ARV-471 in combination with a CDK4/6 inhibitor before the end of the year, we're gratified by the strong momentum of our lead programs heading into 2021."

    "When combined with our recent disclosure of five additional programs in our preclinical pipeline, these clinical milestones further validate our PROTAC® Discovery Engine and the opportunity to create PROTAC® degraders that meaningfully improve patient care," added Dr. Houston.

    Business Highlights and Recent Developments

    • Dose escalation in each of the Phase 1/2 clinical trials of ARV-110 and ARV-471 continues.
    • Arvinas has initiated dosing at a first dose level in a Phase 2 cohort expansion for ARV-110.
    • The company announced platform updates and disclosed five additional programs from its preclinical pipeline. Arvinas' portfolio encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. The newly disclosed programs were B-cell lymphoma 6 protein (BCL6), Kirsten rat sarcoma (KRAS) protein, c-Myc, hematopoietic progenitor kinase 1 (HPK1), and mutant huntingtin (mHTT).
    • Arvinas entered into a collaboration and supply agreement with Pfizer in connection with a planned Phase 1b cohort expansion evaluating ARV-471 in combination with Pfizer's Ibrance® (palbociclib), an oral CDK4/6 inhibitor.

    Anticipated Milestones and Expectations

    2020 Milestones and Expectations

    • Arvinas expects to provide a program update for ARV-110, including a Phase 1 dose escalation update and an overview of the recently initiated Phase 2 dose expansion, in December 2020.
    • For the ARV-471 program, Arvinas expects to provide an update from its Phase 1 dose escalation in December 2020.
    • Arvinas expects to initiate a Phase 1b cohort expansion of ARV-471 in combination with Ibrance® (palbociclib) in the fourth quarter of 2020. The study will evaluate the safety and tolerability of ARV-471 in combination with palbociclib and identify the recommended combination dose of ARV-471 for use with palbociclib.

    2021 Milestones and Expectations

    • Arvinas expects to initiate the first of potentially two Phase 1b investigations of ARV-110 in combination with standard of care agents for mCRPC (e.g., abiraterone) in 2021.
    • Arvinas expects to share interim data from the Phase 2 dose expansion trial of ARV-110 in 2021.
    • Arvinas expects to initiate a Phase 2 dose expansion of ARV-471 in 2021.
    • Arvinas expects to share data from the Phase 1b cohort expansion of ARV-471 in combination with Ibrance® (palbociclib) in the second half of 2021.
    • Arvinas expects to file an investigational new drug (IND) application for ARV-766, an androgen receptor degrader, in the first half of 2021.

    Financial Guidance

    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.

    Financial Highlights

    Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2020, cash, cash equivalents, and marketable securities were $248.6 million as compared with $280.9 million as of December 31, 2019. The decrease in cash, cash equivalents and marketable securities of $32.3 million for the first nine months of 2020 was primarily related to cash used for operations of $64.8 million and the purchase of lab equipment and leasehold improvements of $4.6 million, partially offset by net proceeds from the issuance of common stock and exercises of stock options of $33.1 million and $4.0 million received from two collaborators.

    Research and Development Expenses: Research and development expenses were $30.0 million for the quarter ended September 30, 2020, as compared with $16.6 million for the quarter ended September 30, 2019. The increase in research and development expenses of $13.4 million for the quarter was primarily related to increases in clinical trials and chemistry, manufacturing and controls expenses associated with our AR program of $4.2 million and our ER program of $5.1 million, in addition to increases in expenses of $4.1 million associated with exploratory programs and investments in platform research.

    General and Administrative Expenses: General and administrative expenses were $9.3 million for the quarter ended September 30, 2020, as compared with $8.0 million for the quarter ended September 30, 2019. The increase of $1.3 million was primarily related to an increase in personnel and facility related costs of $2.4 million, offset by a reduction in legal costs of $1.1 million.

    Revenues: Revenue related to the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer (Bayer Collaboration Agreement) that was initiated in July 2019, the collaboration and license agreement with Pfizer (Pfizer Collaboration Agreement) that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017 (collectively Collaboration Revenue) was $7.6 million for the quarter ended September 30, 2020, as compared with $5.4 million for the quarter ended September 30, 2019. The increase in Collaboration Revenue of $2.2 million primarily related to the revenues from the Bayer Collaboration Agreement and the Pfizer Collaboration Agreement. Total revenue of $30.1 for the three months ended September 30, 2019 included $24.7 million for the contribution of a license to Oerth Bio LLC (the Joint Venture).

    Loss from Equity Method Investment: Loss from equity method investment for the quarter ended September 30, 2019 was $24.7 million. This loss was generated from the Joint Venture's expensing the values associated with the contributed intellectual property from the Joint Venture partners.

    Net Loss: Net loss was $30.8 million for the quarter ended September 30, 2020, as compared with $17.7 million for the quarter ended September 30, 2019. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.

    About ARV-110

    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates ARV-110, ARV-471, ARV-766, and other candidates in our pipeline, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, our planned Phase 1b combination trial for ARV-471, our planned Phase 1b combination trials for ARV-110, our planned IND filing for ARV-766, the plans for presentation of data from our Phase 1/1b/2 clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471 and Phase 1b combination trials for ARV-110 or ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications





    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
            
     For the Three Months Ended September 30, For the Nine Months Ended September 30,
      2020   2019   2020   2019 
    Revenue$7,596,776  $30,050,227  $19,584,085  $38,083,205 
    Operating expenses:       
    Research and development 30,012,918   16,588,050   75,155,694   46,779,047 
    General and administrative 9,331,925   7,957,364   26,072,404   20,038,772 
    Total operating expenses 39,344,843   24,545,414   101,228,098   66,817,819 
    Income (loss) from operations (31,748,067)  5,504,813   (81,644,013)  (28,734,614)
    Other income (expenses)       
    Other income, net 144,215   405,302   841,967   840,153 
    Interest income 800,236   1,112,415   3,065,220   3,394,269 
    Interest expense (16,250)  (22,903)  (48,750)  (69,319)
    Total other income 928,201   1,494,814   3,858,437   4,165,103 
    Loss from equity method investment    (24,675,000)     (24,675,000)
    Net loss$(30,819,866) $(17,675,373) $(77,785,576) $(49,244,511)
    Net loss per common share, basic and diluted$(0.79) $(0.54) $(2.01) $(1.54)
    Weighted average common shares outstanding, basic and diluted 39,058,294   32,740,486   38,784,569   31,876,074 





    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
        
     September 30,

    2020
     December 31,

    2019
    Assets   
    Current assets:   
    Cash and cash equivalents$88,988,921  $9,211,057 
    Marketable securities 159,574,963   271,661,456 
    Account receivable 2,444,450    
    Other receivables 3,511,633   6,280,828 
    Prepaid expenses and other current assets 3,459,862   3,727,294 
    Total current assets 257,979,829   290,880,635 
    Property, equipment and leasehold improvements, net 11,712,403   8,455,411 
    Operating lease right of use assets 2,226,422   2,278,623 
    Other assets 28,777   26,757 
    Total assets$271,947,431  $301,641,426 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$5,088,034  $4,556,827 
    Accrued expenses 12,143,734   7,602,904 
    Deferred revenue 21,358,989   19,979,525 
    Current portion of operating lease liability 939,761   673,896 
    Total current liabilities 39,530,518   32,813,152 
    Deferred revenue 23,945,470   38,427,882 
    Long term debt 2,000,000   2,000,000 
    Operating lease liability 1,351,476   1,714,111 
    Total liabilities 66,827,464   74,955,145 
    Commitments and Contingencies   
    Stockholders' equity:   
    Common stock, $0.001 par value; 40,096,001 and 38,461,353 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 40,096   38,461 
    Accumulated deficit (450,342,422)  (372,556,846)
    Additional paid-in capital 654,342,486   599,097,090 
    Accumulated other comprehensive income 1,079,807   107,576 
    Total stockholders' equity 205,119,967   226,686,281 
    Total liabilities and stockholders' equity$271,947,431  $301,641,426 

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  25. NEW HAVEN, Conn., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced platform updates and disclosed five additional programs from its preclinical pipeline. Arvinas' portfolio encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience.

    "We continue to expand our pipeline and further our leadership position in targeted protein degradation by leveraging the PROTAC® Discovery Engine, our integrated platform that we've been advancing since 2013," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "With the programs introduced today, and the…

    NEW HAVEN, Conn., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced platform updates and disclosed five additional programs from its preclinical pipeline. Arvinas' portfolio encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience.

    "We continue to expand our pipeline and further our leadership position in targeted protein degradation by leveraging the PROTAC® Discovery Engine, our integrated platform that we've been advancing since 2013," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "With the programs introduced today, and the important breakthroughs we've made over the years – such as achieving oral bioavailability in human patients and successfully penetrating the blood-brain barrier in preclinical studies – we make it clear that we have the ability to rapidly progress Arvinas' deep pipeline in order to benefit patients in multiple areas of high unmet need."

    "The targets we announced today represent a mix of oncology, immuno-oncology and neuroscience programs," said Ian Taylor, Ph.D., Chief Scientific Officer of Arvinas. "Our progress with classic ‘undruggable' targets like KRAS reinforces our commitment to finding solutions for patients and demonstrates the power of Arvinas' PROTAC® Discovery Engine in generating novel therapies."

    In addition to progressing its platform and preclinical pipeline, Arvinas is testing two PROTAC® protein degraders in human clinical trials: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. Arvinas plans to share updated data for these programs later in the fourth quarter of 2020.

    Newly Announced Programs

    BCL6 (Oncology)

    • B-cell lymphoma 6 protein (BCL6) is a transcriptional repressor implicated in B cell lymphomas and facilitates B cell tolerance of rapid proliferation and somatic gene recombination via repressing cell cycle checkpoints, terminal differentiation, apoptosis, and the DNA damage response. PROTAC®-mediated degradation would address the scaffolding function of BCL6. Arvinas anticipates filing an IND for this program in 2022.

    KRAS (Oncology)

    • Kirsten rat sarcoma (KRAS) is a classic "undruggable" target, due to its lack of deep "pockets," and is associated with poor prognosis and resistance to standards of care in several tumor types. Arvinas is developing pan-KRAS mutant and mutant-specific KRAS degraders, e.g., G12D and G12V. Arvinas anticipates filing an IND for this program in 2023.

    Myc (Oncology)

    • Myelocytomatosis (Myc) proteins are implicated in up to 70% of all human cancers. Targeting Myc indirectly, such as by inhibiting transcription modulators, has not been successful, but PROTAC®-mediated degradation has the potential to directly target and degrade Myc. This is an Exploratory-stage program.

    HPK1 (Immuno-oncology)

    • Hematopoietic progenitor kinase 1 (HPK1) is a suppressor of T cell activation and targeting HPK1 can enhance anti-tumor immune responses. PROTAC®-mediated degradation has the potential to address the proposed scaffolding component of HPK1's activity. This is an Exploratory-stage program.

    mHTT (Neuroscience)

    • Huntington's disease is caused by a mutation in the huntingtin (HTT) gene. PROTAC® degradation has the potential to allow the selective targeting of mutant HTT protein without impacting wild-type HTT protein. This is an Exploratory-stage program.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, such as statements with respect to our lead product candidates, ARV-110 and ARV-471 and other candidates in our pipeline, and the timing of clinical trials and data from those trials, and our development programs that may lead to our development of additional product candidates, the potential utility of our technology and therapeutic potential of our product candidates and the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

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  26. NEW HAVEN, Conn., Oct. 06, 2020 (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 John Houston, Ph.D., President and Chief Executive Officer, will present a keynote plenary session at the 3rd Annual Targeted Protein Degradation Summit being held virtually October 14-15, 2020. The presentation will reflect on Arvinas' advances in its PROTAC® platform and introduce new pipeline programs.

    Presentation Details:

    Title: The Promise of PROTAC® Protein Degraders: What's Next for Arvinas' Pipeline & Platform
    Date: Wednesday, October 14, 2020
    Time: 11:30 a.m. ET

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company…

    NEW HAVEN, Conn., Oct. 06, 2020 (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 John Houston, Ph.D., President and Chief Executive Officer, will present a keynote plenary session at the 3rd Annual Targeted Protein Degradation Summit being held virtually October 14-15, 2020. The presentation will reflect on Arvinas' advances in its PROTAC® platform and introduce new pipeline programs.

    Presentation Details:

    Title: The Promise of PROTAC® Protein Degraders: What's Next for Arvinas' Pipeline & Platform

    Date: Wednesday, October 14, 2020

    Time: 11:30 a.m. ET

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

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  27. NEW HAVEN, Conn., Sept. 04, 2020 (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 Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Citi 15th Annual BioPharma Virtual Conference on Thursday, September 10 at 2:25 p.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening…

    NEW HAVEN, Conn., Sept. 04, 2020 (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 Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Citi 15th Annual BioPharma Virtual Conference on Thursday, September 10 at 2:25 p.m. ET.

    A live audio webcast of the presentation will be available here and on Arvinas' website at www.arvinas.com. A replay of the webcast will be archived on Arvinas' website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

    Primary Logo

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  28. NEW HAVEN, Conn., Aug. 07, 2020 (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 Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the 2020 Wedbush PacGrow Virtual Healthcare Conference on Tuesday, August 11 at 10:20 a.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening…

    NEW HAVEN, Conn., Aug. 07, 2020 (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 Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the 2020 Wedbush PacGrow Virtual Healthcare Conference on Tuesday, August 11 at 10:20 a.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

    Primary Logo

    View Full Article Hide Full Article
  29. NEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.

    "We were pleased to report updated dose escalation data from our Phase 1/2 trial of ARV-110 in men with metastatic castration-resistant prostate cancer. These data demonstrated safety and showed an early efficacy signal in a heavily pretreated patient population, highlighting the potential benefit of our PROTAC® platform. These data are a first for a targeted PROTAC® protein degrader, and we are excited to report more mature data from our…

    NEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.

    "We were pleased to report updated dose escalation data from our Phase 1/2 trial of ARV-110 in men with metastatic castration-resistant prostate cancer. These data demonstrated safety and showed an early efficacy signal in a heavily pretreated patient population, highlighting the potential benefit of our PROTAC® platform. These data are a first for a targeted PROTAC® protein degrader, and we are excited to report more mature data from our ARV-110 program, and to announce interim data from our ARV-471 Phase 1/2 trial, in the fourth quarter of 2020," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas.

    "As we look to the balance of 2020, we are in a stronger position than ever to lead the creation of an entirely new class of therapies that targets and degrades disease-causing proteins," added Dr. Houston. 

     Business Highlights and Recent Developments

    • The company presented early efficacy and updated safety data for ARV-110 at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The data demonstrated that Arvinas' PROTAC protein degrader ARV-110 had an acceptable safety profile (as of the data cut-off) and are the first to show early signs of clinical efficacy for ARV-110 in a heavily pretreated patient population.
    • The company enhanced its Board of Directors with the appointments of Linda Bain and Wendy Dixon, Ph.D.

    Anticipated Milestones and Expectations

    • For the ARV-110 program, Arvinas expects to provide an update from its Phase 1/2 trial in the fourth quarter of 2020.
    • For the ARV-471 program, Arvinas expects to share Phase 1 dose escalation clinical data in the fourth quarter of 2020.
    • Arvinas expects to provide information about the advancement of additional programs in its robust preclinical pipeline in the second half of 2020.

    Financial Guidance

    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.

    Financial Highlights

    Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2020, cash, cash equivalents, and marketable securities were $242.7 million as compared with $280.9 million as of December 31, 2019. The decrease in cash, cash equivalents and marketable securities of $38.2 million for the first six months of 2020 was primarily related to cash used for operations of $43.2 million and the purchase of lab equipment and lease hold improvements of $3.2 million, partially offset by $4.0 million received from two collaborators, cash provided from the exercise of stock options of $2.6 million and changes in unrealized gain on marketable securities of $1.6 million.

    Research and Development Expenses: Research and development expenses were $23.4 million for the quarter ended June 30, 2020, as compared with $16.0 million for the quarter ended June 30, 2019. The increase in research and development expenses of $7.4 million for the quarter was primarily related to increases in clinical trial and CMC expenses associated with our AR program of $2.3 million and our ER program of $1.0 million, in addition to increases in preclinical expenses of $4.1 million associated with exploratory programs and investments in platform research.

    General and Administrative Expenses: General and administrative expenses were $8.8 million for the quarter ended June 30, 2020, as compared to $6.4 million for the quarter ended June 30, 2019. The increase of $2.4 million was primarily related to an increase in personnel and facility related costs of $2.2 million.

    Revenues: Revenue was $5.7 million for the quarter ended June 30, 2020, as compared with $4.0 million for the quarter ended June 30, 2019. The increase of $1.7 million was primarily related to the collaboration and license agreement with Bayer that was initiated in July 2019. Revenues are generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.

    Net Loss: Net loss was $25.2 million for the quarter ended June 30, 2020, as compared with $17.2 million for the quarter ended June 30, 2019. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.

    About ARV-110

    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471

    ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.



    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
             
      For the Three Months

    Ended June 30,
     For the Six Months

    Ended June 30,
       2020   2019   2020   2019 
    Revenue $5,747,681  $4,016,489  $11,987,309  $8,032,979 
    Operating expenses:        
    Research and development  23,416,090   16,000,638   45,142,776   30,190,996 
    General and administrative  8,815,474   6,440,779   16,740,479   12,081,409 
    Total operating expenses  32,231,564   22,441,417   61,883,255   42,272,405 
    Income (loss) from operations  (26,483,883)  (18,424,928)  (49,895,946)  (34,239,426)
    Other income (expenses)        
    Other income, net  307,743   191,729   697,752   434,850 
    Interest income  965,851   1,091,331   2,264,984   2,281,853 
    Interest expense  (16,250)  (22,778)  (32,500)  (46,416)
    Total other income  1,257,344   1,260,282   2,930,236   2,670,287 
    Net loss $(25,226,539) $(17,164,646) $(46,965,710) $(31,569,139)
    Net loss per common share, basic and diluted $(0.65) $(0.55) $(1.22) $(1.01)
    Weighted average common shares outstanding, basic

      and diluted
      38,739,922   31,440,051   38,644,209   31,408,658 



    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
         
      June 30,

    2020
     December 31,

    2019
    Assets    
    Current assets:    
    Cash and cash equivalents $21,593,656  $9,211,057 
    Marketable securities  221,103,306   271,661,456 
    Other receivables  3,564,317   6,280,828 
    Prepaid expenses and other current assets  3,320,609   3,727,294 
    Total current assets  249,581,888   290,880,635 
    Property, equipment and leasehold improvements, net  10,541,408   8,455,411 
    Operating lease right of use assets  2,429,500   2,278,623 
    Other assets  28,777   26,757 
    Total assets $262,581,573  $301,641,426 
    Liabilities and stockholders' equity    
    Current liabilities:    
    Accounts payable $2,429,757  $4,556,827 
    Accrued expenses  7,404,460   7,602,904 
    Deferred revenue  22,964,819   19,979,525 
    Current portion of operating lease liability  920,765   673,896 
    Total current liabilities  33,719,801   32,813,152 
    Deferred revenue  27,489,590   38,427,882 
    Long term debt  2,000,000   2,000,000 
    Operating lease liability  1,590,758   1,714,111 
    Total liabilities  64,800,149   74,955,145 
    Commitments and Contingencies    
    Stockholders' equity:    
    Common stock, $0.001 par value; 38,825,190 and 38,461,353 shares

      issued and outstanding as of June 30, 2020 and December 31,

      2019, respectively
      38,825   38,461 
    Accumulated deficit  (419,522,556)  (372,556,846)
    Additional paid-in capital  615,601,031   599,097,090 
    Accumulated other comprehensive income  1,664,124   107,576 
    Total stockholders' equity  197,781,424   226,686,281 
    Total liabilities and stockholders' equity $262,581,573  $301,641,426 

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications 

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  30. NEW HAVEN, Conn., June 29, 2020 (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 Wendy Dixon, Ph.D., has joined its Board of Directors. Dr. Dixon is a well-respected leader with 40 years of broad and deep experience in the biopharmaceutical industry, including a strong track record of successful product launches.

    "We are pleased to welcome Wendy to Arvinas' Board of Directors and look forward to her valuable insight related to key functions such as marketing, strategic planning, and business development," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "Wendy is joining Arvinas at a…

    NEW HAVEN, Conn., June 29, 2020 (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 Wendy Dixon, Ph.D., has joined its Board of Directors. Dr. Dixon is a well-respected leader with 40 years of broad and deep experience in the biopharmaceutical industry, including a strong track record of successful product launches.

    "We are pleased to welcome Wendy to Arvinas' Board of Directors and look forward to her valuable insight related to key functions such as marketing, strategic planning, and business development," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "Wendy is joining Arvinas at a very exciting time as we continue to grow and accomplish milestones that bring us closer to our mission of offering therapeutic options to patients who have few or none."

    Dr. Dixon currently serves as a Director for Incyte Corporation, Alkermes plc, bluebird bio, and Voyager Therapeutics. She previously served as a Director and Chair of Sesen Bio and as a Director for Ardea Biosciences, Furiex Pharmaceuticals, and Dentsply International. Additionally, she served as an Independent Director for Edimer Therapeutics, a private company. From 2001 to 2009, Dr. Dixon was Chief Marketing Officer & President of Global Marketing at Bristol-Myers Squibb, as well as a member of the CEO's Executive Committee. Prior to this she served as Senior Vice President of Marketing for Merck & Co., Inc. Dr. Dixon also held senior vice president roles at West Pharmaceuticals, Osteotech, Inc., Centocor, Inc., and Smith Kline & French Pharmaceuticals. Throughout her career in the pharmaceutical and biotechnology industry, Dr. Dixon has been responsible for building and leading organizations, and launching and growing more than 20 pharmaceutical products including Tagamet, Fosamax, Singulair, Plavix, Abilify, Reyataz and Baraclude. Dr. Dixon received her B.Sc., M.Sc. and Ph.D. from the University of Cambridge, UK.

    "Arvinas is leading the way in targeted protein degradation and has already proven the concept of their proprietary PROTAC® platform," added Dr. Dixon. "The company has a promising future ahead and I am very pleased to contribute to its continued success."

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Media Contacts

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

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  31. NEW HAVEN, Conn., June 17, 2020 (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 Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23 at 8:30 a.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating…

    NEW HAVEN, Conn., June 17, 2020 (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 Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23 at 8:30 a.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

    Primary Logo

    View Full Article Hide Full Article
  32. NEW HAVEN, Conn., June 11, 2020 (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 Linda Bain has joined its Board of Directors. Ms. Bain, who is currently the Chief Financial Officer of Codiak BioSciences, Inc., is an experienced business and financial leader with a strong track record of driving results, accelerating growth, and building shareholder value.  

    "Linda is an excellent addition to Arvinas' Board of Directors and her deep operational expertise will be highly valuable as Arvinas continues to grow," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "Linda's experience in biotech…

    NEW HAVEN, Conn., June 11, 2020 (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 Linda Bain has joined its Board of Directors. Ms. Bain, who is currently the Chief Financial Officer of Codiak BioSciences, Inc., is an experienced business and financial leader with a strong track record of driving results, accelerating growth, and building shareholder value.  

    "Linda is an excellent addition to Arvinas' Board of Directors and her deep operational expertise will be highly valuable as Arvinas continues to grow," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "Linda's experience in biotech will be a tremendous asset as we progress our trials and execute our strategic plan."

    Ms. Bain is an accomplished executive with extensive experience influencing strategy and leading the finances and operations of biotechnology and pharmaceutical companies. Prior to joining Codiak, Ms. Bain served as Chief Financial Officer of Avalanche Biotechnologies, where she led a successful initial public offering (IPO) and follow-on financing. Additionally, she served as Vice President of Finance, Business Operations, and Treasurer, as well as Chief Accounting Officer, at bluebird bio, where she led a successful Series D financing and IPO. Prior to bluebird bio, Ms. Bain held senior roles at Genzyme Corporation and was Vice President of Finance, Global Manufacturing and Operations, and Vice President of Finance, Genzyme Genetics. Earlier in her career she held senior roles at Fidelity Investments, AstraZeneca, and Deloitte & Touche. Ms. Bain is a Certified Public Accountant and earned a Bachelor of Science in Accounting and Business Administration and an Honors degree in Accounting and Business Administration from the University of the Free State, Bloemfontein South Africa.

    "It's an incredibly exciting time to join Arvinas' Board of Directors," added Ms. Bain. "Arvinas has made tremendous progress in targeted protein degradation and proven the concept of their PROTAC® platform targeted protein degradation, and I very much look forward to contributing to its continued success."

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Media Contacts

    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

     

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  33. NEW HAVEN, Conn., June 05, 2020 (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 Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the Goldman Sachs 41st  Annual Global Healthcare Conference on Thursday, June 11 at 4:40 p.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating…

    NEW HAVEN, Conn., June 05, 2020 (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 Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the Goldman Sachs 41st  Annual Global Healthcare Conference on Thursday, June 11 at 4:40 p.m. ET.

    A live audio webcast of the presentation will be available here and on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas



    Investors

    Will O'Connor, Stern Investor Relations

    Media

    Kirsten Owens, Arvinas Communications

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  34. - Clear efficacy signal with two ongoing confirmed PSA responses, including one associated with a confirmed RECIST response -

    - Data represent the first demonstration of PROTAC®-mediated degradation of a disease-causing protein in humans -

    NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) --  Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated data from the dose escalation portion of the company's Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC), to be shared as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020. ARV-110 is…

    - Clear efficacy signal with two ongoing confirmed PSA responses, including one associated with a confirmed RECIST response -

    - Data represent the first demonstration of PROTAC®-mediated degradation of a disease-causing protein in humans -

    NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) --  Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated data from the dose escalation portion of the company's Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC), to be shared as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020. ARV-110 is a potent, selective, orally available androgen receptor (AR) degrader, and the ASCO presentation highlights promising clinical activity, including both efficacy and AR degradation, in a heavily pretreated patient population. ­

    "For ARV-110 to show signs of efficacy in these patients at this early stage of development is strong validation of our PROTAC® technology," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "In addition, seeing AR degradation demonstrates that ARV-110 is acting on-mechanism to achieve this result, and we are excited to continue clinical development in the hope of bringing a new therapeutic option to patients with significant unmet need."

    "The responses we see are the first powerful examples in patients of the potential benefits of protein degradation pharmacology compared to classic inhibition or antagonism, which failed in these patients while degradation showed clinical benefit," added Ron Peck, M.D., Chief Medical Officer at Arvinas. "This is a patient population where other therapies would be expected to have little to no benefit, and we are very pleased with the early clinical efficacy data and safety profile we are seeing and think it bodes well for both ARV-110 and the PROTAC® platform."

    The dose escalation portion of Arvinas' Phase 1/2 clinical trial of ARV-110 is designed to assess safety, tolerability, and pharmacokinetics (PK) in men with mCRPC who have progressed on standard of care therapies, as well as to identify a recommended Phase 2 dose. To date, ARV-110 has shown a favorable safety profile, and PK have been generally dose proportional, reaching exposures associated with tumor inhibition in preclinical models at 140 mg. In the data released today, Arvinas also shared evidence of in-tumor AR reduction, the first demonstration of successful targeted protein degradation by a PROTAC® protein degrader in humans.

    ARV-110 has demonstrated evidence of activity at doses and in AR mutational backgrounds in which responses would be expected based on preclinical data. As of the April 20, 2020 data cut-off, 20 patients were evaluable for prostate-specific antigen (PSA) response, including 12 patients treated at 140 mg or higher (these 12 patients exclude one patient who received two weeks of therapy prior to discontinuing due to a rosuvastatin-related dose limiting toxicity).

    Of those 12 patients treated at 140 mg and above, circulating tumor DNA (ctDNA) analysis of five patients showed AR forms not degradable by ARV-110 in preclinical studies (i.e., L702H point mutations and AR-V7 splice variants). In the group of seven remaining patients who had forms of AR degradable by ARV-110 (other AR point mutations, AR amplification, and wildtype AR), two patients achieved confirmed PSA responses that remain ongoing with additional follow-up since the abstract was submitted.

    One of these patients had a 74% decline from baseline in PSA and remained without progression after 30 weeks, as of the data cut-off. This patient did not have measurable disease at baseline for assessment by Response Evaluation Criteria in Solid Tumors (RECIST). The second patient had both a deep PSA response (97% decline from baseline) and a confirmed RECIST response (80% decrease from baseline in tumor mass) and remains without progression after 18 weeks. Both responses, which were in patients at the 140 mg dose, were achieved by ARV-110 despite prior enzalutamide, abiraterone, chemotherapy, and other therapies. Tumors from both patients have H875Y and T878A point mutations in AR, which are known to drive resistance to current standard of care treatments and have been degraded by ARV-110 in preclinical studies. In addition to these two patients, PSA reductions were observed in other patients but did not meet a 50% reduction in PSA threshold at data cutoff, and four patients remain on ARV-110 without radiographic progression for at least 20 weeks.

    A potential drug-drug interaction between ARV-110 and rosuvastatin (ROS) was identified during the trial. Of the 22 patients enrolled, two had concurrent use of ROS. One patient receiving 280 mg ARV-110 experienced a Grade 4 dose-limiting toxicity (DLT) of elevated aspartate transaminase/alanine transaminase (AST/ALT) followed by acute renal failure. The second patient, receiving 70 mg ARV-110, experienced a Grade 3 AST/ALT elevation, which resolved after the removal of ROS, and the patient was retreated with ARV-110. Follow-up exploratory findings indicate that ROS concentrations were elevated in both patients who had liver function test (LFT) increases. Subsequent in vitro transport pump studies indicate that ARV-110 inhibits breast cancer resistant pump (BCRP) transporter, of which ROS is a substrate. Following the initial data that supported a potential interaction with ROS, concomitant use of ROS was precluded, and no other related Grade 3 or 4 adverse events have since been reported. Six other patients have received concomitant non-ROS statins without AST/ALT adverse events. 

    Dose escalation and enrollment continues, with the most recent cohort initiating dosing in May 2020 at 420 mg. The expansion portion of the Phase 1/2 trial is expected to begin once the recommended Phase 2 dose has been determined and will evaluate the anti-tumor activity of ARV-110 through assessment of PSA response, using the Prostate Cancer Working Group 3 Criteria, and overall RECIST response rate in patients with measurable disease. The expansion will further investigate a link between AR genomic profile and efficacy, which could inform an enrichment strategy. Arvinas plans to provide updated information on the ARV-110 Phase 1/2 study by the end of 2020. 

    Arvinas Webcast Investor Meeting
    The company will host a conference call and webcast at 8:30 AM ET today to discuss these data. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode access code 8069179. A listen-only webcast of the conference call can also be accessed through the "Investors + Media" tab on the Arvinas website, www.arvinas.com, and a replay will be available for six weeks following the call.

    About ARV-110
    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

    Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Up to 25 percent of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the vast majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements, our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Media Contacts

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Kirsten Owens, Arvinas Communications

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  35. NEW HAVEN, Conn., May 20, 2020 (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 its 2020 Annual Meeting of Stockholders, to be held on Wednesday, June 3, 2020 at 8:30 a.m. Eastern Time, has been changed to a virtual meeting. Stockholders will only be able to participate in this year's Annual Meeting via the virtual meeting. This change is reflective of the public health impact of the novel coronavirus (COVID-19) outbreak, government restrictions limiting the size of gatherings, and supporting the health and well-being of Arvinas' stockholders, employees, and communities.

    Stockholders are entitled to participate…

    NEW HAVEN, Conn., May 20, 2020 (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 its 2020 Annual Meeting of Stockholders, to be held on Wednesday, June 3, 2020 at 8:30 a.m. Eastern Time, has been changed to a virtual meeting. Stockholders will only be able to participate in this year's Annual Meeting via the virtual meeting. This change is reflective of the public health impact of the novel coronavirus (COVID-19) outbreak, government restrictions limiting the size of gatherings, and supporting the health and well-being of Arvinas' stockholders, employees, and communities.

    Stockholders are entitled to participate in and vote at the Annual Meeting if they were a stockholder at the close of business on April 6, 2020, the record date, or hold a legal proxy for the meeting provided by the stockholder's bank, broker or nominee as of such record date. To access, participate in, and vote at the Annual Meeting, stockholders must register in advance at the Annual Meeting Website (viewproxy.com/Arvinas/2020) prior to the deadline of 11:59 p.m. MDT on May 31, 2020. Upon completing registration, eligible participants will receive further instructions via email, including unique links that will allow such eligible participants to access the meeting.

    Stockholders may submit questions during the Annual Meeting through the virtual meeting platform. Additional information regarding the virtual meeting are included in a proxy supplement that the company has filed today with the Securities and Exchange Commission.

    Please note that the proxy card included with the proxy materials previously distributed will not be updated to reflect the change in location and may continue to be used to vote your shares in connection with the Annual Meeting.

    All stockholders – whether attending the Annual Meeting or not – are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. Stockholders may also vote online during the Annual Meeting by following the instructions available on the Annual Meeting Website.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Media Contacts

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Kirsten Owens, Arvinas Communications

    Primary Logo

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  36. - Describes the first evidence of clinical benefit for PROTAC® protein degraders, a novel therapeutic modality -

    - Data to be presented during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting -

    NEW HAVEN, Conn., May 13, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated safety and initial efficacy data contained in an abstract scheduled as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29–31, 2020. The presentation will share updated data from the dose escalation portion of Arvinas' Phase 1/2 clinical trial of ARV-110 in men…

    - Describes the first evidence of clinical benefit for PROTAC® protein degraders, a novel therapeutic modality -

    - Data to be presented during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting -

    NEW HAVEN, Conn., May 13, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated safety and initial efficacy data contained in an abstract scheduled as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29–31, 2020. The presentation will share updated data from the dose escalation portion of Arvinas' Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer. The abstract describes two patients with ongoing confirmed prostate-specific antigen (PSA) responses, including one with an unconfirmed partial tumor response.

    "We are thrilled to present the first evidence that our PROTAC® protein degrader, ARV-110, can provide clinical efficacy," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "This is a significant milestone for our technology platform and for the field of targeted protein degradation."

    "While still early, we are pleased to see a safety profile to date for ARV-110 that continues to support dose escalation," added Ron Peck, M.D., Chief Medical Officer at Arvinas. "Our trial of ARV-110 has enrolled a particularly heavily pre-treated population of patients who have exhausted most available treatment options. Most patients received both enzalutamide and abiraterone as well as prior chemotherapy. Despite this, ARV-110 demonstrated the first evidence of antitumor activity in this difficult-to-treat patient population."

    The presentation will include data collected since the abstract submission date. Dose escalation continues, with enrollment initiated above the previously disclosed daily dose of 280 milligrams.

    Abstract details are as follows:
    Presentation Title: First-in-human phase I study of ARV-110, an androgen receptor PROTAC degrader in patients with metastatic castrate-resistant prostate cancer following enzalutamide and/or abiraterone
    Abstract Number: 3500
    Session Type: Oral Abstract Session
    Session Track: Development Therapeutics – Molecularly Targeted Agents and Tumor Biology

    For a copy of the abstract, please visit ASCO's official website.

    About ARV-110
    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

    Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Up to 25 percent of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the vast majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements, our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Media Contacts

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Kirsten Owens, Arvinas Communications

    Primary Logo

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  37. NEW HAVEN, Conn., April 28, 2020 (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 first quarter ended March 31, 2020 and provided a corporate update.

    "Throughout the first quarter, we continued to execute our plan and have made steady progress in our clinical pipeline. We are excited to present updated clinical data from our Phase 1/2 dose escalation trial of ARV-110, as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC), at the American Society of Clinical Oncology (ASCO) annual meeting this quarter. We look forward to further discussing the potential…

    NEW HAVEN, Conn., April 28, 2020 (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 first quarter ended March 31, 2020 and provided a corporate update.

    "Throughout the first quarter, we continued to execute our plan and have made steady progress in our clinical pipeline. We are excited to present updated clinical data from our Phase 1/2 dose escalation trial of ARV-110, as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC), at the American Society of Clinical Oncology (ASCO) annual meeting this quarter. We look forward to further discussing the potential of ARV-110 in this vulnerable patient population," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas.

    "As we move through the year, we remain committed to implementing a strategy that leverages our innovative PROTAC® protein degradation platform and continuing to invest in advancing our entire pipeline," added Dr. Houston.

    Anticipated Milestones and Expectations

    • For the ARV-110 program, Arvinas expects to share updated data from the dose escalation portion of its Phase 1/2 clinical study in men with mCRPC in a presentation at the virtual ASCO annual meeting in the second quarter of 2020.
    • For the ARV-471 program, which is being studied in patients with locally advanced or metastatic ER+/HER2- breast cancer, Arvinas expects to share data from the dose escalation portion of its Phase 1/2 clinical trial in the second half of 2020.
    • In the second half of 2020, Arvinas expects to provide information about the advancement of additional programs in its robust preclinical pipeline.

    Financial Guidance
    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.

    • Cash, Cash Equivalents, and Marketable Securities Position: As of March 31, 2020, cash, cash equivalents, and marketable securities were $262.8 million as compared with $280.9 million as of December 31, 2019. The decrease of $18.1 million primarily related to cash used to fund operations of $20.9 million and cash used to purchase fixed assets and leasehold improvements of $1.4 million, partially offset by receipts from collaborators of $4.0 million.
    • Research and Development Expenses: Research and development expenses were $21.7 million for the quarter ended March 31, 2020 as compared with $14.2 million for the quarter ended March 31, 2019. The increase of $7.5 million in research and development expenses for the quarter primarily related to increasing investments in platform research, exploratory and lead optimization programs, our estrogen receptor (ER) clinical program and our androgen receptor (AR) clinical program.
    • General and Administrative Expenses: General and administrative expenses were $7.9 million for the quarter ended March 31, 2020 as compared with $5.6 million for the quarter ended March 31, 2019. The increase of $2.3 million in general and administrative expenses for the quarter was primarily related to increases in personnel and facility-related costs.
    • Revenue: Revenue was $6.2 million for the quarter ended March 31, 2020 as compared with $4.0 million for the quarter ended March 31, 2019. The increase of $2.2 million in revenue is primarily due to revenue related to the Bayer collaboration agreement, which was initiated in July 2019, and an increase in license and rights to technology fees and research and development activities related to the Pfizer collaboration agreement.
    • Net Loss: Net loss was $21.7 million for the quarter ended March 31, 2020 as compared with $14.4 million for the quarter ended March 31, 2019. The increase of $7.3 million in net loss for the quarter primarily related to our increasing investments in platform research, exploratory and lead optimization programs, our ARV-471 clinical program, our ARV-110 clinical program, and increases in general and administrative personnel costs partially offset by an increase in revenue primarily related to the Bayer collaboration agreement that was initiated in July 2019 and an increase in license and rights to technology fees and research and development activities related to the Pfizer collaboration agreement.

    About ARV-110
    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC).

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471
    ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. 

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements, our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.


    Arvinas, Inc.
    Consolidated Statement of Operations (Unaudited)
             
        For the Three Months
    Ended March 31,
          2020       2019  
    Revenue   $   6,239,628     $   4,016,489  
    Operating expenses:        
    Research and development       21,726,686         14,190,359  
    General and administrative       7,925,005         5,640,629  
    Total operating expenses       29,651,691         19,830,988  
    Income (loss) from operations       (23,412,063 )       (15,814,499 )
    Other income (expenses)        
    Other income, net       390,009         243,122  
    Interest income       1,299,133         1,190,523  
    Interest expense       (16,250 )       (23,638 )
    Total other income       1,672,892         1,410,007  
    Net loss       (21,739,171 )       (14,404,492 )
    Net loss per common share, basic and diluted   $   (0.56 )   $   (0.46 )
    Weighted average common shares outstanding, basic
      and diluted
          38,548,483         31,325,516  



    Arvinas, Inc.
    Consolidated Balance Sheet (Unaudited)
             
        March 31,
    2020
      December 31,
    2019
    Assets        
    Current assets:        
    Cash and cash equivalents   $   36,106,323     $   9,211,057  
    Marketable securities       226,728,165         271,661,456  
    Other receivables       3,878,438         6,280,828  
    Prepaid expenses and other current assets       3,482,238         3,727,294  
    Total current assets       270,195,164         290,880,635  
    Property, equipment and leasehold improvements, net       9,575,768         8,455,411  
    Operating lease right of use assets       2,650,090         2,278,623  
    Other assets       28,777         26,757  
    Total assets   $   282,449,799     $   301,641,426  
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable   $   3,020,794     $   4,556,827  
    Accrued expenses       6,783,724         7,602,904  
    Deferred revenue       22,464,819         19,979,525  
    Current portion of operating lease liability       899,653         673,896  
    Total current liabilities       33,168,990         32,813,152  
    Deferred revenue       33,730,795         38,427,882  
    Long term debt       2,000,000         2,000,000  
    Operating lease liability       1,842,901         1,714,111  
    Total liabilities       70,742,686         74,955,145  
    Commitments and Contingencies        
    Stockholders' equity:        
    Common stock, $0.001 par value; 38,672,433 and 38,461,353 shares
      issued and outstanding as of March 31, 2020 and December 31, 2019,
      respectively
          38,672         38,461  
    Accumulated deficit       (394,296,017 )       (372,556,846 )
    Additional paid-in capital       606,567,072         599,097,090  
    Accumulated other comprehensive income (loss)       (602,614 )       107,576  
    Total stockholders' equity       211,707,113         226,686,281  
    Total liabilities and stockholders' equity   $   282,449,799     $   301,641,426  


    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR

     

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  38. NEW HAVEN, Conn., April 13, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today provided an update regarding the impact of the COVID-19 pandemic on its overall business continuity, including clinical trials, supply chain, and discovery research.

    Throughout the ongoing COVID-19 pandemic, Arvinas remains committed to keeping employees and their families safe and to reduce the number of people exposed to the virus. Arvinas also remains committed to continuing to create a new class of drugs based on targeted protein degradation, including continued development of the company's PROTAC® protein degraders currently in ongoing clinical…

    NEW HAVEN, Conn., April 13, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today provided an update regarding the impact of the COVID-19 pandemic on its overall business continuity, including clinical trials, supply chain, and discovery research.

    Throughout the ongoing COVID-19 pandemic, Arvinas remains committed to keeping employees and their families safe and to reduce the number of people exposed to the virus. Arvinas also remains committed to continuing to create a new class of drugs based on targeted protein degradation, including continued development of the company's PROTAC® protein degraders currently in ongoing clinical trials.

    In early March 2020, Arvinas activated business continuity plans to minimize business disruption and ensure employee well-being. Arvinas continues to expect planned clinical data releases for ARV-110 or ARV-471. Nonetheless, the company cannot rule out future business impacts and will, if necessary, provide further updates on business performance when reporting financial results for the first quarter of 2020.

    Clinical Trials

    Arvinas continues to monitor the impact of COVID-19 on its ongoing clinical trials. The safety of patients and staff at the sites engaged in ARV-110 and ARV-471 studies remains Arvinas' priority.

    Arvinas is working closely with the study centers to understand the potential impact of COVID-19 on trial enrollment. Arvinas' clinical trials each utilize four sites for enrollment and the company expects that sites that can safely continue to enroll patients will continue to do so. Recently, Yale-New Haven Hospital (YNHH) and Massachusetts General Hospital (MGH), both sites in Arvinas' ARV-110 study, as well as the University of California – Los Angeles (UCLA), a site in Arvinas' ARV-471 study, all have publicly announced pauses in patient enrollment for clinical trials, including Arvinas' trials. The pause at UCLA has already been lifted and new patients for the ARV-471 trial are permitted to enroll. Arvinas will continue to collaborate with YNHH and MGH to understand the timing of enrollment restarts while maintaining the safety of patients as our top priority.  

    At sites that have paused enrollment, patients already enrolled and who remain on study will continue to receive scheduled doses and be assessed for safety and other clinical endpoints. Arvinas is working with all sites to develop contingency plans that maintain the highest standards for patient care and study data integrity while affording flexibility in study visits during the COVID-19 pandemic, consistent with recent FDA guidance on the management of clinical studies during the pandemic. These contingency plans include the potential use of telemedicine and local testing for laboratory assessments, instituting remote monitoring plans, providing study drug directly to patients, and allowing certain assessments to be completed virtually while maintaining data integrity. The contract research organizations (CROs) Arvinas relies on for the conduct of its clinical trials and the third parties used for monitoring secondary endpoints continue to operate without interruption in services.

    Arvinas does not expect COVID-19 to have any impact to the planned timing of clinical data releases for ARV-110 (at the 2020 annual meeting of the American Society for Clinical Oncology) and ARV-471 (in the second half of 2020).

    Supply Chain
                 
    Arvinas continues to monitor the activities of our suppliers of starting materials, drug substances, and drug products. The Arvinas supply chain is geographically distributed, and while there have been some delays at contract manufacturing organizations (CMOs), Arvinas does not currently anticipate impacts to the clinical supply requirements for ongoing clinical trials of ARV-110 and ARV-471.

    Discovery Research

    Arvinas' chemistry work on early-stage programs continues, including both PROTAC® design and synthesis. While Arvinas has significantly reduced work in its biology laboratories as part of a company-wide effort to protect its employees and the community, the company is engaging third party contract research organizations to minimize disruption to ongoing research activities beyond ARV-110 and ARV-471.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the plans for our ongoing clinical trials, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates, our plans and expectations in light of and in response to the COVID-19 pandemic and its impacts on the United States healthcare systems, global pharmaceutical supply chain and our business. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: the risks that the COVID-19 pandemic may disrupt our business and/or the United States healthcare system and global pharmaceutical supply chain more severely than we have anticipated, which may have the effect of delaying our ability to enroll and complete our ongoing Phase 1 clinical trials for ARV-110 and ARV-471, complete other clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR


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  39. NEW HAVEN, Conn., March 31, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the acceptance of an abstract for presentation at the American Society of Clinical Oncology (ASCO) annual meeting being held virtually May 29 - June 2, 2020. The presentation will include updated clinical data from the Arvinas' Phase 1 dose escalation trial of ARV-110.  

    ARV-110 is one of Arvinas' two clinical-stage PROTAC® protein degraders and is being developed for the treatment of men with metastatic castration-resistant prostate cancer.  The second is ARV-471, which is in a Phase 1 dose escalation trial for patients with locally advanced…

    NEW HAVEN, Conn., March 31, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the acceptance of an abstract for presentation at the American Society of Clinical Oncology (ASCO) annual meeting being held virtually May 29 - June 2, 2020. The presentation will include updated clinical data from the Arvinas' Phase 1 dose escalation trial of ARV-110.  

    ARV-110 is one of Arvinas' two clinical-stage PROTAC® protein degraders and is being developed for the treatment of men with metastatic castration-resistant prostate cancer.  The second is ARV-471, which is in a Phase 1 dose escalation trial for patients with locally advanced or metastatic ER+/HER2- breast cancer. The next clinical update for ARV-471 is planned for the second half of 2020.

    About ARV-110
    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas' Phase 1 trial of ARV-110 is designed to assess its safety, tolerability, and pharmacokinetics, and includes measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471
    ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic breast cancer. Arvinas' Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, our scheduled participation at the ASCO annual meeting, the presentation of data from our clinical trials for ARV-110 and ARV-471, and the potential advantages and therapeutic potential of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, complete other clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR

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  40. NEW HAVEN, Conn., March 16, 2020 (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 fourth quarter and full year ended December 31, 2019 and provided a corporate update.

    "2019 was an exciting year for Arvinas, marked by tremendous clinical and corporate progress. We were delighted to present the first human clinical data from targeted protein degraders along with preclinical data demonstrating the brain-penetrating potential of our PROTAC® protein degraders. These data underscore the potential of our platform to create safe and well-tolerated drugs for the treatment of a variety of life-threatening…

    NEW HAVEN, Conn., March 16, 2020 (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 fourth quarter and full year ended December 31, 2019 and provided a corporate update.

    "2019 was an exciting year for Arvinas, marked by tremendous clinical and corporate progress. We were delighted to present the first human clinical data from targeted protein degraders along with preclinical data demonstrating the brain-penetrating potential of our PROTAC® protein degraders. These data underscore the potential of our platform to create safe and well-tolerated drugs for the treatment of a variety of life-threatening diseases," said John Houston, Ph.D., Chief Executive Officer of Arvinas.

    Business Highlights and Recent Developments

    • Presented initial clinical safety and pharmacokinetic data for ARV-110 (as a treatment for men with metastatic castration-resistant prostate cancer) and ARV-471 (as a therapy for patients with locally advanced or metastatic ER+/HER2- breast cancer). These data showed that ARV-110 and ARV-471 were well-tolerated and safe for further development at the doses disclosed in October 2019. Further, both PROTAC® protein degraders reached exposure levels in human patients that were correlated with tumor inhibition oral regression in preclinical models.
    • Closed an underwritten public offering of 5,227,273 shares of common stock at a public offering price of $22.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Arvinas received net proceeds of approximately $107.6 million, after deducting underwriting discounts and commissions and offering expenses.
    • Presented preclinical data demonstrating that oligomer-specific PROTAC® molecules degraded aggregates of human alpha-synuclein in primary rat neurons.
    • Announced the appointment of Laurie Smaldone Alsup, M.D., to Arvinas' board of directors. Dr. Smaldone Alsup currently serves as Chief Scientific Officer and Chief Medical Officer for NDA Group. She brings experience leading commercially successful product approvals and global regulatory strategies that have successfully advanced programs through all stages of clinical development.

    Anticipated Milestones and Expectations

    • For the ARV-110 program, Arvinas expects to share Phase 1 dose escalation clinical data in the second quarter of 2020.
    • For the ARV-471 program, Arvinas expects to share Phase 1 dose escalation clinical data in the second half of 2020.
    • In the second half of 2020, Arvinas expects to provide information about the advancement of additional programs in its robust preclinical pipeline. 

    Financial Guidance
    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.

    Full Year and Fourth Quarter Financial Results

    • Cash, Cash Equivalents and Marketable Securities Position: As of December 31, 2019, cash, cash equivalents and marketable securities were $280.9 million as compared with $187.8 million as of December 31, 2018. The increase primarily related to net proceeds from a public offering of common stock of $107.6 million, aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer and collaborator milestone and other payments of $7.8 million, partially offset by cash used to fund operations of approximately $67.6 million and cash used to purchase fixed assets and leasehold improvements of $6.2 million. Cash, cash equivalents, and marketable securities increased by $90.4 million in the fourth quarter of 2019. This increase primarily related to net proceeds from a public offering of common stock of $107.6 million and collaborator milestone and other payments of $2.2 million, partially offset by cash used to fund operations of approximately $17.6 million and cash used to purchase fixed assets and leasehold improvements of $1.8 million.
    • Research and Development Expenses: Research and development expenses were $67.2 million and $20.4 million for the year and quarter ended December 31, 2019, respectively as compared with $45.2 million and $14.6 million for the year and quarter ended December 31, 2018, respectively. The increase in research and development expenses for the year and quarter primarily related to Arvinas' continued investment in its platform, exploratory and lead optimization programs and its estrogen receptor (ER) and androgen receptor (AR) clinical development programs.
    • General and Administrative Expenses: General and administrative expenses were $27.3 million and $7.3 million for the year and quarter ended December 31, 2019, respectively, as compared with $12.9 million and $5.8 million for the year and quarter ended December 31, 2018, respectively. The increase in general and administrative expenses for the year and quarter primarily related to increasing infrastructure costs and being a public company for a full year in 2019.
    • Revenues: Revenue was $43.0 million and $4.9 million for the year and quarter ended December 31, 2019, respectively, as compared with $14.3 million and $3.4 million for the year and quarter ended December 31, 2018, respectively. Revenue for the year ended December 31, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC® technology in agricultural applications (the Joint Venture). The remaining revenue of $18.3 million and revenue of $4.9 million for the year and quarter ended December 31, 2019, respectively, was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.
    • Loss from Equity Method Investment: Loss from equity method investment for the year ended December 31, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture's expensing the values associated with the contributed intellectual property from the Joint Venture partners.
    • Net Loss: Net loss was $70.3 million and $21.0 million for the year and quarter ended December 31, 2019, respectively, as compared with $41.5 million and $16.1 million for the year and quarter ended December 31, 2018, respectively. The increase in net loss for the year and quarter primarily related to Arvinas' continued investment in its platform, exploratory and lead optimization programs, its ER program, its AR program and increase in general and administrative infrastructure costs related to the first full year as a public company offset by an increase in revenue primarily related to the Bayer collaboration that was initiated in July 2019.

    About ARV-110
    ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas' Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

    About ARV-471
    ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic ER+/HER2- breast cancer. Arvinas' Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, including the timing of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

      Arvinas, Inc.
      Consolidated Statement of Operations (Unaudited)
                   
          Quarter Ended December 31, Year Ended December 31,
            2019     2018       2019     2018  
      Revenue   $ 4,893,273   $ 3,440,165     $ 42,976,478   $ 14,323,920  
      Operating expenses:            
      Research and development     20,414,783     14,562,299       67,193,830     45,193,830  
      General and administrative     7,268,390     5,821,445       27,307,162     12,932,168  
      Total operating expenses     27,683,173     20,383,744       94,500,992     58,125,998  
      Loss from operations     (22,789,900 )   (16,943,579 )     (51,524,514 )   (43,802,078 )
      Interest and other income     1,742,184     855,713       5,907,287     2,321,612  
      Loss from equity method investment     -     -       (24,675,000 )   -  
      Net loss     (21,047,716 )   (16,087,866 )     (70,292,227 )   (41,480,466 )
      Change in redemption value of redeemable preferred units                   (198,366,756 )
      Net loss attributable to common units/shares   $ (21,047,716 ) $ (16,087,866 )   $ (70,292,227 ) $ (239,847,222 )
      Net loss per common unit/share, basic and diluted   $ (0.56 ) $ (0.52 )   $ (2.13 ) $ (25.45 )
      Weighted average common units/shares outstanding, basic and diluted     37,338,484     31,098,634       32,927,697     9,422,799  
                   


      Arvinas, Inc.
      Consolidated Balance Sheet (Unaudited)
               
          December 31,
            2019       2018  
      Assets        
      Current assets:        
      Cash and cash equivalents   $ 9,211,057     $ 3,190,056  
      Marketable securities     271,661,456       184,637,640  
      Account receivable     -       2,775,831  
      Other receivables     6,280,828       2,255,966  
      Prepaid expenses and other current assets     3,727,294       2,818,286  
      Total current assets     290,880,635       195,677,779  
      Property, equipment and leasehold improvements, net     8,455,411       3,583,036  
      Operating lease right of use assets     2,278,623       -  
      Other assets     26,757       20,760  
      Total assets   $ 301,641,426     $ 199,281,575  
      Liabilities and stockholders' equity        
      Current liabilities:        
      Accounts payable   $ 4,556,827     $ 2,758,184  
      Accrued expenses     7,602,904       4,001,276  
      Deferred revenue     19,979,525       16,065,957  
      Current portion of long-term debt     -       154,461  
      Current portion of operating lease liability     673,896       -  
      Total current liabilities     32,813,152       22,979,878  
      Deferred revenue     38,427,882       37,484,714  
      Long term debt, net of current portion     2,000,000       2,000,000  
      Operating lease liability     1,714,111       -  
      Other non-current liability     -       150,000  
      Total liabilities     74,955,145       62,614,592  
      Commitments and contingencies        
      Stockholders' equity:        
      Common stock, $0.001 par value, 38,461,353 and 31,235,458 shares issued and outstanding as of December 31, 2019 and 2018, respectively     38,461       31,236  
      Accumulated deficit     (372,556,846 )     (302,264,619 )
      Additional paid-in capital     599,097,090       439,118,089  
      Accumulated other comprehensive loss     107,576       (217,723 )
      Total stockholders' equity     226,686,281       136,666,983  
      Total liabilities and stockholders' equity   $ 301,641,426     $ 199,281,575  
               

    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR

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  41. NEW HAVEN, Conn., Nov. 27, 2019 (GLOBE NEWSWIRE) -- Arvinas Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Thursday, December 5 at 12:00 p.m. ET in New York, NY.

    A live audio webcast of the presentation will be available on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening…

    NEW HAVEN, Conn., Nov. 27, 2019 (GLOBE NEWSWIRE) -- Arvinas Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Thursday, December 5 at 12:00 p.m. ET in New York, NY.

    A live audio webcast of the presentation will be available on the Company's website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

    About Arvinas
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.

    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR

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  42. NEW HAVEN, Conn., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, announced today that Laurie Smaldone Alsup, M.D., has joined its board of directors. Dr. Smaldone Alsup, who is currently the Chief Scientific Officer and Chief Medical Officer for NDA Group, brings experience leading commercially successful product approvals and global regulatory strategies that have advanced programs through all stages of clinical development.

    "Laurie has a track record of leading the regulatory approval efforts for dozens of marketed products, increasing patient access to new medicines around the globe," said John Houston, Ph.D., President and CEO…

    NEW HAVEN, Conn., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, announced today that Laurie Smaldone Alsup, M.D., has joined its board of directors. Dr. Smaldone Alsup, who is currently the Chief Scientific Officer and Chief Medical Officer for NDA Group, brings experience leading commercially successful product approvals and global regulatory strategies that have advanced programs through all stages of clinical development.

    "Laurie has a track record of leading the regulatory approval efforts for dozens of marketed products, increasing patient access to new medicines around the globe," said John Houston, Ph.D., President and CEO of Arvinas. "At Arvinas, our mission is to bring innovative new medicines to patients with limited treatment options. Laurie's guidance will be important as we advance our lead programs through development and begin preparing for commercialization."

    Dr. Smaldone Alsup has nearly 30 years of experience in the pharmaceutical industry, helping companies develop accelerated commercialization and market access strategies in the U.S. and global markets. Her expertise is broadly focused across therapeutic areas including cancer, HIV/AIDS, infectious diseases, rare diseases, and metabolic, neurologic, and immunologic disorders. She spent over 20 years at Bristol Myers Squibb in roles of increasing responsibility in clinical development, regulatory strategy, and corporate risk management. Dr. Smaldone Alsup received her M.D. from the Yale School of Medicine and completed her residency in Internal Medicine at Yale New Haven Hospital and a fellowship in Medical Oncology at Yale. She currently serves on the boards of Blackberry Ltd. and Theravance Biopharma.

    "Arvinas is advancing the first targeted protein degraders through clinical development, recently presenting their first clinical data on lead programs ARV-110 and ARV-471," said Dr. Smaldone Alsup. "Throughout my career, I have had the great pleasure of helping companies build effective global development strategies to bring valuable new medicines to patients. I look forward to joining the Arvinas team as they prepare to advance their novel programs through the regulatory approval process."

    About ARV-110
    ARV-110 is an orally-bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas' Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. 

    About ARV-471
    ARV-471 is a PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic breast cancer. Arvinas' Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

    In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

    About Arvinas:
    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates and the potential advantages and therapeutic potential of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, complete our other clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements, our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Contacts for Arvinas

    Investors
    Will O'Connor, Stern Investor Relations

    Media
    Cory Tromblee, ScientPR

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  43. NEW HAVEN, Conn., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the pricing of an underwritten public offering of 4,545,455 shares of its common stock at a price of $22.00 per share, before underwriting discounts and commissions. In addition, Arvinas has granted the underwriters an option for a period of 30 days to purchase up to an additional 681,818 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arvinas.

    Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray & Co. are acting as joint book-running managers for the offering…

    NEW HAVEN, Conn., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the pricing of an underwritten public offering of 4,545,455 shares of its common stock at a price of $22.00 per share, before underwriting discounts and commissions. In addition, Arvinas has granted the underwriters an option for a period of 30 days to purchase up to an additional 681,818 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arvinas.

    Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray & Co. are acting as joint book-running managers for the offering. The offering is expected to close on or about November 12, 2019, subject to customary closing conditions.

    A shelf registration statement on Form S-3 (File No. 333-234035) relating to the shares of common stock offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on October 10, 2019. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing ; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 800-831-9146; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at .

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Arvinas, Inc.

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the proposed public offering, including the closing of the public offering. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to satisfaction of customary closing conditions related to the public offering, whether we will be able to conduct, complete and receive results from clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the SEC. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Investor Relations:
    Will O'Connor
    Stern Investor Relations

    Media:
    Cory Tromblee
    ScientPR

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  44. NEW HAVEN, Conn., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that it is commencing an underwritten public offering of $90.0 million of shares of its common stock.  In addition, Arvinas intends to grant the underwriters an option for a period of 30 days to purchase up to an additional $13.5 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by Arvinas.

    Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray…

    NEW HAVEN, Conn., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that it is commencing an underwritten public offering of $90.0 million of shares of its common stock.  In addition, Arvinas intends to grant the underwriters an option for a period of 30 days to purchase up to an additional $13.5 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by Arvinas.

    Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray & Co. are acting as joint book-running managers for the offering.

    A shelf registration statement on Form S-3 (File No. 333-234035) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on October 10, 2019. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering is being filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing ; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 800-831-9146; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at .

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Arvinas, Inc.

    Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the proposed public offering, including the completion of the public offering on the anticipated terms, or at all. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to market and other financial conditions, satisfaction of customary closing conditions related to the proposed public offering, whether we will be able to conduct, complete and receive results from clinical trials for our product candidates on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the SEC. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

    Investor Relations:   
    Will O'Connor
    Stern Investor Relations

    Media:           
    Cory Tromblee
    ScientPR

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  45. NEW HAVEN, Conn., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter of 2019 and provided a corporate update.

    "We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs. In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC® protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our PROTAC® platform," said John Houston, Ph.D., Chief Executive Officer of Arvinas. "We look forward to the continued progress of…

    NEW HAVEN, Conn., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter of 2019 and provided a corporate update.

    "We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs. In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC® protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our PROTAC® platform," said John Houston, Ph.D., Chief Executive Officer of Arvinas. "We look forward to the continued progress of our lead programs and pipeline, and ultimately to making a difference in the lives of patients."

    Business Highlights and Recent Developments

    • Presented initial data from the company's ongoing Phase 1 clinical trials of ARV-110 and ARV-471. The initial data showed dose proportionality for ARV-110 and that exposures of both ARV-110 and ARV-471 have reached levels associated with tumor growth inhibition in preclinical studies. In addition, both ARV-110 and ARV-471, at each dose tested to date, were well tolerated, with no dose-limiting toxicities and no observed grade 2, 3, or 4 adverse events related to treatment.
    • Presented preclinical data from the company's alpha-synuclein (a-synuclein)-targeted PROTAC® protein degrader program. The data showed that the company has created a-synuclein-targeted degraders that degrade oligomeric a-synuclein. In addition, the company has created a-synuclein-targeting PROTAC® protein degraders that cross the blood-brain barrier following parenteral (peripheral) administration.
    • Announced that six new oncology and neurology thought leaders in the areas of oncology and neurological disorders have joined the company's scientific advisory board (SAB). The new members are Tomasz M. Beer, M.D., F.A.C.P., Adam L. Boxer, M.D., Ph.D., Sara Courtneidge, Ph.D., Lennart Mucke, M.D., Benjamin G. Neel, M.D., Ph.D., and Lillian L. Siu, M.D. For full details on our new SAB members, visit www.arvinas.com.
    • Initiated patient dosing in its ongoing Phase 1 clinical trial of ARV-471, which is evaluating the safety, tolerability, and pharmacokinetics of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer.

    Anticipated Milestones and Expectations

    • For the ARV-110 program, Arvinas expects to next share completed Phase 1 dose escalation clinical data in the first half of 2020.
    • For the ARV-471 program, Arvinas expects to next share clinical data in the second half of 2020.

    Financial Guidance

    Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient