On May 5, 2022 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, 2022 and provided a corporate update (Press release, Arvinas, MAY 5, 2022, View Source [SID1234613671]).
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!
"It has been a very productive first quarter for Arvinas, as we prepare to initiate three planned pivotal clinical studies in the second half of 2022 for our two lead programs – ARV-471 in metastatic breast cancer and bavdegalutamide in molecularly defined metastatic castration-resistant prostate cancer," said John Houston, Ph.D., chief executive officer and president at Arvinas. "We have a unique opportunity to bring these two programs into late-stage development at the same time, demonstrating the potential of our PROTAC platform to selectively and efficiently degrade and remove disease-causing proteins."
Business Highlights and Recent Developments
In February, Arvinas presented completed Phase 1 dose escalation data and interim data from the ongoing Phase 2 ARDENT expansion cohort with bavdegalutamide in metastatic castration-resistant prostate cancer (mCRPC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), that showed:
A PSA50 rate (reduced prostate-specific antigen (PSA) levels greater than or equal to 50%) of 46% in patients with AR T878X/H875Y (T878X = T878A or T878S) tumor mutations (n=28)
Two durable, confirmed RECIST (Response Evaluation Criteria in Solid Tumors) partial responses (out of seven RECIST-evaluable patients with AR T878X/H875Y tumor mutations)
Bavdegalutamide had a manageable tolerability profile at the recommended Phase 2 dose (RP2D) of 420 mg oral, once daily
PSA reductions and evidence of anti-tumor activity as measured by RECIST were observed across all subgroups regardless of mutation status, including in patients with tumors not harboring AR T878X/875Y mutations
Anticipated 2022 Milestones and Expectations
ARV-471
Present data from the VERITAC Phase 2 expansion trial (200 mg and 500 mg) (2H 2022)
Present safety data from the Phase 1b combination trial with palbociclib (2H 2022)
Initiate two Phase 3 trials in patients with metastatic breast cancer (as monotherapy and in combination) (2H 2022)
Initiate a Phase 1b combination trial with cyclin dependent kinase (CDK) inhibitors or other targeted therapies (2H 2022)
Initiate a Phase 1b combination trial with everolimus (2H 2022)
Initiate a Phase 2 neoadjuvant trial in patients with early breast cancer (2H 2022)
Bavdegalutamide (ARV-110)
Discuss the potential accelerated approval path with the Food and Drug Administration (FDA) (Q2 2022)
Finalize partnership for a companion diagnostic (Q2 2022)
Initiate a pivotal trial in mCRPC for patients with AR T878/H875 tumor mutations (2H 2022)
ARV-766
Share Phase 1 dose escalation data in mCRPC (2H 2022)
Initiate Phase 2 expansion trial in mCRPC (2H 2022)
First Quarter Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of March 31, 2022, cash, cash equivalents, restricted cash and marketable securities were $1,432.9 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 $74.2 million for the first three months of 2022 was primarily related to cash used in operating activities of $60.5 million (net of $6.5 million received from two collaborators), unrealized loss on marketable securities of $14.1 million, and the purchase of lab equipment and leasehold improvements of $2.1 million, partially offset by proceeds from the exercise of stock options of $2.5 million.
Research and Development Expenses: Research and development expenses were $64.0 million for the quarter ended March 31, 2022, as compared with $34.9 million for the quarter ended March 31, 2021. The increase in research and development expenses of $29.1 million for the quarter was primarily due to an increase in our continued investment in our platform and exploratory programs of $11.0 million, as well as an increase in expenses related to our AR program (which includes bavdegalutamide and ARV-766) of $8.9 million and our ER program of $9.2 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).
General and Administrative Expenses: General and administrative expenses were $20.2 million for the quarter ended March 31, 2022, as compared with $12.3 million for the quarter ended March 31, 2021. The increase of $7.9 million was primarily due to an increase in personnel and facility related costs of $5.5 million and insurance and professional fees of $2.4 million.
Revenues: Revenues were $24.2 million for the quarter ended March 31, 2022, as compared with $5.5 million for the quarter ended March 31, 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 $18.7 million was due to revenue from the ARV-471 Collaboration Agreement.
Income Tax Expense: Income tax expense was $4.5 million for the quarter ended March 31, 2022, as compared with zero for the quarter ended March 31, 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 $63.4 million for the quarter ended March 31, 2022, as compared with $41.0 million for the quarter ended March 31, 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 (ARV-110) is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.
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
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 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.