On April 28, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Arvinas, APR 28, 2020, View Source [SID1234556668]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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) (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.