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Arvinas Reports Second Quarter 2022 Financial Results and Provides Corporate Update | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: GlobeNewswire - 04 Aug 2022 | Back to overview list |
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NEW HAVEN, Conn., Aug. 04, 2022 (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, 2022 and provided a corporate update. “This is an exciting time at Arvinas as we remain on track to initiate two pivotal programs with ARV-471 in metastatic breast cancer in the second half of this year, have a clear development pathway for bavdegalutamide in molecularly defined metastatic castration-resistant prostate cancer, and are preparing to initiate our Phase 2 trial with ARV-766 by end of year,” said John Houston, Ph.D., president and chief executive officer at Arvinas. “In June, we had a collaborative meeting with the U.S. Food and Drug Administration to gain alignment on the registrational trial design for bavdegalutamide. Based on our goal of advancing this important potential treatment for prostate cancer as quickly as possible, the promising clinical data we’ve seen to date, and a productive meeting with the Agency, we have decided to move directly into a pivotal Phase 3 trial. If successful, we think this approach may lead to the fastest potential path to availability for patients in need, both inside and outside the United States, and who are most likely to benefit from this innovative therapy.” Business Highlights and Recent Developments
Anticipated Upcoming Milestones and Expectations ARV-471
Bavdegalutamide (ARV-110)
ARV-766
Financial Guidance Second Quarter Financial Results Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of June 30, 2022, cash, cash equivalents, restricted cash and marketable securities were $1,347.7 million as compared with $1,507.1 million as of December 31, 2021. The decrease in cash, cash equivalents, restricted cash and marketable securities of $159.4 million for the first six months of 2022 was primarily related to cash used in operating activities of $141.5 million (net of $6.5 million received from two collaborators), unrealized loss on marketable securities of $17.4 million, and the purchase of lab equipment and leasehold improvements of $3.5 million, partially offset by proceeds from the exercise of stock options of $3.0 million. Research and Development Expenses: Research and development expenses were $75.3 million for the quarter ended June 30, 2022, as compared with $43.0 million for the quarter ended June 30, 2021. The increase in research and development expenses of $32.3 million for the quarter was primarily due to an increase in our continued investment in our platform and exploratory programs of $19.6 million, as well as an increase in expenses related to our ER program of $14.1 million, which is net of the cost sharing of ARV-471 under the global Pfizer collaboration agreement to develop and commercialize ARV-471 that was initiated in July 2021 (ARV-471 Collaboration Agreement), offset by a decrease in our AR program (which includes bavdegalutamide and ARV-766) of $1.4 million. General and Administrative Expenses: General and administrative expenses were $24.3 million for the quarter ended June 30, 2022, as compared with $14.4 million for the quarter ended June 30, 2021. The increase of $9.9 million was primarily due to an increase in personnel and facility related costs of $6.9 million and insurance, taxes and professional fees of $2.9 million. Revenues: Revenues were $31.3 million for the quarter ended June 30, 2022 as compared with $5.5 million for the quarter ended June 30, 2021. Revenue is related to the ARV-471 Collaboration Agreement, 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 $25.8 million was primarily due to revenue from the ARV-471 Collaboration Agreement. Income Tax Expense: Income tax expense was $3.4 million for the quarter ended June 30, 2022, as compared with zero for the quarter ended June 30, 2021 due to taxable income projected for fiscal year 2022 primarily related to revenue recognized in 2022 for tax purposes from the ARV-471 Collaboration Agreement. Net Loss: Net loss was $70.0 million for the quarter ended June 30, 2022, as compared with $50.3 million for the quarter ended June 30, 2021. The increase in net loss for the quarter was primarily due to increased research and development expenses, general and administrative expenses, and income tax expense, partially offset by increased revenue. About bavdegalutamide (ARV-110) Bavdegalutamide 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 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 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 Forward-Looking Statements 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, as applicable, Pfizer, will be able to successfully conduct and complete clinical development of our product candidates, including whether we initiate and receive results from our clinical trials on our expected timelines or at all, obtain marketing approval for and commercialize ARV-471, bavdegalutamide, 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. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of the Pfizer collaboration and the potential advantages and therapeutic benefits of ARV-471, bavdegalutamide, ARV-766 and our other product candidates, the future development and potential marketing approval and commercialization of ARV-471, bavdegalutamide, ARV-766 and our other product candidates, including the initiation of and 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: 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 initiate and receive results from our clinical trials on our expected timelines or at all, obtain marketing approval for and commercialize ARV-471, bavdegalutamide, 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 Media:
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Copyright 2022 GlobeNewswire | Back to overview list |