Arvinas Reports First Quarter 2021 Financial Results and Provides Corporate Update
05/04/2021 - 07:00 AM
NEW HAVEN, Conn., May 04, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
“Last quarter we reinforced our leadership position in the targeted protein degradation space by sharing the discovery and chemical structures of ARV-110 and ARV-471 at the American Association for Cancer Research (AACR) Annual Meeting, the first such disclosure of our clinical-stage PROTAC degraders,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “We look forward to further demonstrating the potential of our PROTAC platform to change the lives of patients with few or no therapeutic options.”
Business Highlights and Recent Developments
Presented preclinical data describing the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures at AACR Anticipated Milestones and Expectations
ARV-471
Completion of the Phase 1 dose escalation (1H21) Presentation of completed Phase 1 dose escalation data (2H21) Interim review of safety and dose finding data from the Phase 1b trial in combination with Ibrance® (palbociclib) (2H21) Initiation of a window of opportunity study in early breast cancer (2H21) Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21) ARV-110
Completion of the Phase 1 dose escalation (1H21) 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(s) with standard(s)-of-care (2021) Other Clinical Milestones
Initiation of 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 (1H21) 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 2024.
First Quarter Financial Results
Cash, Cash Equivalents and Marketable Securities Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $651.3 million as compared with $688.5 million as of December 31, 2020. The decrease primarily related to cash used to fund operations of $43.9 million , cash used to purchase fixed assets and leasehold improvements of $1.0 million and unrealized losses of $0.8 million , partially off-set by proceeds from two collaborators of $4.0 million and proceeds from the exercise of stock options of $4.5 million .
Research and Development Expenses: Research and development expenses were $34.9 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in research and development expenses for the quarter of $13.2 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs of $8.3 million , its AR program of $1.5 million and estrogen receptor program (ER) of $3.4 million .
General and Administrative Expenses: General and administrative expenses were $12.3 million for the quarter ended March 31, 2021 as compared with $7.9 million for the quarter ended March 31, 2020. The increase in general and administrative expenses for the quarter of $4.4 million related to an increase of $3.6 million in personnel and facility related costs, including $1.8 million related to stock compensation expense, and insurance, taxes and professional fees of $0.8 million .
Revenues : Revenues were $5.5 million for the quarter ended March 31, 2021 as compared with $6.2 million for the quarter ended March 31, 2020 and 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. The decrease in collaboration revenue of $0.7 million for the quarter was primarily related to a collaborator adding new targets that extended the period of revenue recognition for that collaboration agreement.
Net Loss: Net loss was $41.0 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in net loss for the quarter ended March 31, 2021 of $19.3 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs, its AR program, its ER program, and an increase in general and administrative costs.
About ARV-110
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
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.
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 www.arvinas.com .
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 will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471 or conduct a Phase 1 clinical trial for ARV-766, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline 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 ir@arvinas.com
Media kirsten.owens@arvinas.com
Arvinas, Inc. Consolidated Statement of Operations (Unaudited) Three Months Ended March 31, 2021 2020 Revenue $ 5,539,365 $ 6,239,628 Operating expenses: Research and development 34,866,882 21,726,686 General and administrative 12,318,713 7,925,005 Total operating expenses 47,185,595 29,651,691 Loss from operations (41,646,230 ) (23,412,063 ) Interest and other income 681,939 1,672,892 Net loss (40,964,291 ) (21,739,171 ) Net loss per common share, basic and diluted (0.84 ) (0.56 ) Weighted average common shares outstanding, basic and diluted 48,621,663 38,548,483
Arvinas, Inc. Consolidated Balance Sheet (Unaudited) March 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 346,068,406 $ 588,373,232 Marketable securities 305,203,086 100,157,618 Account receivable — 1,000,000 Other receivables 5,175,378 7,443,654 Prepaid expenses and other current assets 8,209,888 6,113,122 Total current assets 664,656,758 703,087,626 Property, equipment and leasehold improvements, net 12,210,324 12,259,515 Operating lease right of use assets 4,876,584 1,992,669 Other assets 28,777 28,777 Total assets $ 681,772,443 $ 717,368,587 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 9,002,938 $ 7,121,879 Accrued expenses 8,001,201 18,859,840 Deferred revenue 22,150,861 22,150,861 Current portion of operating lease liabilities 1,216,914 952,840 Total current liabilities 40,371,914 49,085,420 Deferred revenue 20,400,518 22,938,233 Long term debt, net of current portion 2,000,000 2,000,000 Operating lease liabilities 3,701,991 1,087,422 Total liabilities 66,474,423 75,111,075 Commitments and contingencies Stockholders' equity: Common stock, $0.00 1 par value, 48,785,692 and 48,455,741 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 48,786 48,455 Accumulated deficit (532,853,201 ) (491,888,910 ) Additional paid-in capital 1,148,345,190 1,133,537,171 Accumulated other comprehensive income (242,755 ) 560,796 Total stockholders' equity 615,298,020 642,257,512 Total liabilities and stockholders' equity $ 681,772,443 $ 717,368,587
