On November 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter of 2019 and provided a corporate update (Press release, Arvinas, NOV 4, 2019, View Source [SID1234550226]).
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"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 to fund its planned operating expenses and capital expenditure requirements into the second half of 2021.
Financial Highlights
Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2019, cash, cash equivalents, and marketable securities were $190.5 million as compared to $187.8 million as of December 31, 2018. The increase in cash, cash equivalents and marketable securities of $2.7 million in the first nine months of 2019 primarily related to aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer, partially offset by the purchase of lab equipment and leasehold improvements of $4.5 million and cash used to fund operations of $49.7 million.
Research and Development Expenses: Research and development expenses were $16.6 million for the quarter ended September 30, 2019, as compared to $13.1 million for the quarter ended September 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with our ongoing Phase 1 clinical trial of ARV-110 and the initiation of our Phase 1 clinical trial of ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory programs research.
General and Administrative Expenses: General and administrative expenses were $8.0 million for the quarter ended September 30, 2019, as compared to $4.3 million for the quarter ended September 30, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming a public company in the fourth quarter of 2018.
Revenues: Revenue was $30.1 million for the quarter ended September 30, 2019, as compared to $3.4 million for the quarter ended September 30, 2018. Revenue for the quarter ended September 30, 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 $5.4 million for the quarter 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 quarter ended September 30, 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 $17.7 million for the quarter ended September 30, 2019, as compared to $13.4 million for the quarter ended September 30, 2018. The increased revenue that related to the Joint Venture was offset by the loss from equity method investment in the Joint Venture for the quarter ended September 30, 2019 and as such, 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 (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 as a single agent and in combination with a CDK4/6 inhibitor when compared to a standard of care agent, fulvestrant (as a single agent and in combination with a CDK4/6 inhibitor).