ARVN Arvinas Inc.

84.5
-3.59  -4%
Previous Close 88.09
Open 86.41
52 Week Low 19.68
52 Week High 108.465
Market Cap $4,449,238,749
Shares 52,653,713
Float 41,824,958
Enterprise Value $3,885,346,601
Volume 152,216
Av. Daily Volume 324,363
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Upcoming Catalysts

Drug Stage Catalyst Date
ARV-471
ER+ positive / HER2- negative breast cancer
Phase 1b
Phase 1b
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ARV-110 (ARDENT)
Castration-resistant prostate cancer (CRPC)
Phase 1/2
Phase 1/2
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Latest News

  1. 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

    swheeler@wheelhouselsa.com



    Elizabeth Wolffe, Ph.D.

    Wheelhouse LSA

    lwolffe@wheelhouselsa.com





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  2. 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

    ir@arvinas.com

    Media

    Kirsten Owens, Arvinas Communications

    kirsten.owens@arvinas.com



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  3. 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 pr@insilico.com.

     

    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

    SOURCE Insilico Medicine

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  4. 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

    ir@arvinas.com

    Media

    Kirsten Owens, Arvinas Communications

    kirsten.owens@arvinas.com

    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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  5. – 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

    ir@arvinas.com

    Arvinas Media Contact:

    Kirsten Owens, Arvinas Communications

    kirsten.owens@arvinas.com

    Pfizer Investor Contact:

    Chuck Triano

    +1 (212) 733-3901

    Charles.E.Triano@Pfizer.com

    Pfizer Media Contact:

    Eamonn Nolan

    +1 (212) 733-4626

    Eamonn.Nolan@pfizer.com



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