NEW HAVEN, Conn., April 28, 2020 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2020 and provided a corporate update.
“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) 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
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.
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.
About Arvinas
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 locally advanced or metastatic ER+/HER2- 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, the plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation 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 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our 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, 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.
| Arvinas, Inc. | ||||||||
| Consolidated Statement of Operations (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenue | $ | 6,239,628 | $ | 4,016,489 | ||||
| Operating expenses: | ||||||||
| Research and development | 21,726,686 | 14,190,359 | ||||||
| General and administrative | 7,925,005 | 5,640,629 | ||||||
| Total operating expenses | 29,651,691 | 19,830,988 | ||||||
| Income (loss) from operations | (23,412,063 | ) | (15,814,499 | ) | ||||
| Other income (expenses) | ||||||||
| Other income, net | 390,009 | 243,122 | ||||||
| Interest income | 1,299,133 | 1,190,523 | ||||||
| Interest expense | (16,250 | ) | (23,638 | ) | ||||
| Total other income | 1,672,892 | 1,410,007 | ||||||
| Net loss | (21,739,171 | ) | (14,404,492 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.56 | ) | $ | (0.46 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 38,548,483 | 31,325,516 | ||||||
| Arvinas, Inc. | ||||||||
| Consolidated Balance Sheet (Unaudited) | ||||||||
| March 31, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,106,323 | $ | 9,211,057 | ||||
| Marketable securities | 226,728,165 | 271,661,456 | ||||||
| Other receivables | 3,878,438 | 6,280,828 | ||||||
| Prepaid expenses and other current assets | 3,482,238 | 3,727,294 | ||||||
| Total current assets | 270,195,164 | 290,880,635 | ||||||
| Property, equipment and leasehold improvements, net | 9,575,768 | 8,455,411 | ||||||
| Operating lease right of use assets | 2,650,090 | 2,278,623 | ||||||
| Other assets | 28,777 | 26,757 | ||||||
| Total assets | $ | 282,449,799 | $ | 301,641,426 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,020,794 | $ | 4,556,827 | ||||
| Accrued expenses | 6,783,724 | 7,602,904 | ||||||
| Deferred revenue | 22,464,819 | 19,979,525 | ||||||
| Current portion of operating lease liability | 899,653 | 673,896 | ||||||
| Total current liabilities | 33,168,990 | 32,813,152 | ||||||
| Deferred revenue | 33,730,795 | 38,427,882 | ||||||
| Long term debt | 2,000,000 | 2,000,000 | ||||||
| Operating lease liability | 1,842,901 | 1,714,111 | ||||||
| Total liabilities | 70,742,686 | 74,955,145 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par value; 38,672,433 and 38,461,353 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 38,672 | 38,461 | ||||||
| Accumulated deficit | (394,296,017 | ) | (372,556,846 | ) | ||||
| Additional paid-in capital | 606,567,072 | 599,097,090 | ||||||
| Accumulated other comprehensive income (loss) | (602,614 | ) | 107,576 | |||||
| Total stockholders’ equity | 211,707,113 | 226,686,281 | ||||||
| Total liabilities and stockholders’ equity | $ | 282,449,799 | $ | 301,641,426 | ||||
Contacts for Arvinas
Investors
Will O’Connor, Stern Investor Relations
ir@arvinas.com
Media
Cory Tromblee, ScientPR
pr@arvinas.com