Full Press Release Details
Arvinas Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
NEW HAVEN, Conn. March 16, 2020 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 fourth quarter and full year ended December 31, 2019 and provided a corporate update.
2019 was an exciting year for Arvinas, marked by tremendous clinical and corporate progress. We were delighted to present the first human clinical data
from targeted protein degraders along with preclinical data demonstrating the brain-penetrating potential of our PROTAC protein degraders. These data underscore the potential of our platform
to create safe and well-tolerated drugs for the treatment of a variety of life-threatening diseases, said John Houston, Ph.D., Chief Executive Officer of Arvinas.
Business Highlights and Recent Developments
Anticipated Milestones and Expectations
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.
Full Year and Fourth Quarter Financial Results
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.
ARV-471 is an orally bioavailable PROTAC protein
degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic ER+/HER2- 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 when compared to a standard of care
agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening
diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The
company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of
patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the
development and regulatory status of our product candidates, including the timing of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and
therapeutic potential of our product candidates and the sufficiency of cash resources. 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: whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, 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
Contacts for Arvinas
Will O Connor, Stern Investor
Cory Tromblee, ScientPR
Consolidated Statement of Operations (Unaudited)
| Quarter Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue | $ | 4,893,273 | $ | 3,440,165 | $ | 42,976,478 | $ | 14,323,920 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 20,414,783 | 14,562,299 | 67,193,830 | 45,193,830 | ||||||||||||
| General and administrative | 7,268,390 | 5,821,445 | 27,307,162 | 12,932,168 | ||||||||||||
| Total operating expenses | 27,683,173 | 20,383,744 | 94,500,992 | 58,125,998 | ||||||||||||
| Loss from operations | (22,789,900 | ) | (16,943,579 | ) | (51,524,514 | ) | (43,802,078 | ) | ||||||||
| Interest and other income | 1,742,184 | 855,713 | 5,907,287 | 2,321,612 | ||||||||||||
| Loss from equity method investment | (24,675,000 | ) | ||||||||||||||
| Net loss | (21,047,716 | ) | (16,087,866 | ) | (70,292,227 | ) | (41,480,466 | ) | ||||||||
| Change in redemption value of redeemable preferred units | (198,366,756 | ) | ||||||||||||||
| Net loss attributable to common units/shares | $ | (21,047,716 | ) | $ | (16,087,866 | ) | $ | (70,292,227 | ) | $ | (239,847,222 | ) | ||||
| Net loss per common unit/share, basic and diluted | $ | (0.56 | ) | $ | (0.52 | ) | $ | (2.13 | ) | $ | (25.45 | ) | ||||
| Weighted average common units/shares outstanding, basic and diluted | 37,338,484 | 31,098,634 | 32,927,697 | 9,422,799 |
Consolidated Balance Sheet (Unaudited)
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,211,057 | $ | 3,190,056 | ||||
| Marketable securities | 271,661,456 | 184,637,640 | ||||||
| Account receivable | 2,775,831 | |||||||
| Other receivables | 6,280,828 | 2,255,966 | ||||||
| Prepaid expenses and other current assets | 3,727,294 | 2,818,286 | ||||||
| Total current assets | 290,880,635 | 195,677,779 | ||||||
| Property, equipment and leasehold improvements, net | 8,455,411 | 3,583,036 | ||||||
| Operating lease right of use assets | 2,278,623 | |||||||
| Other assets | 26,757 | 20,760 | ||||||
| Total assets | $ | 301,641,426 | $ | 199,281,575 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,556,827 | $ | 2,758,184 | ||||
| Accrued expenses | 7,602,904 | 4,001,276 | ||||||
| Deferred revenue | 19,979,525 | 16,065,957 | ||||||
| Current portion of long-term debt | 154,461 | |||||||
| Current portion of operating lease liability | 673,896 | |||||||
| Total current liabilities | 32,813,152 | 22,979,878 | ||||||
| Deferred revenue | 38,427,882 | 37,484,714 | ||||||
| Long term debt, net of current portion | 2,000,000 | 2,000,000 | ||||||
| Operating lease liability | 1,714,111 | |||||||
| Other non-current liability | 150,000 | |||||||
| Total liabilities | 74,955,145 | 62,614,592 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.001 par value, 38,461,353 and 31,235,458 shares issued and outstanding as of December 31, 2019 and 2018, respectively | 38,461 | 31,236 | ||||||
| Accumulated deficit | (372,556,846 | ) | (302,264,619 | ) | ||||
| Additional paid-in capital | 599,097,090 | 439,118,089 | ||||||
| Accumulated other comprehensive loss | 107,576 | (217,723 | ) | |||||
| Total stockholders equity | 226,686,281 | 136,666,983 | ||||||
| Total liabilities and stockholders equity | $ | 301,641,426 | $ | 199,281,575 |