Arvinas Reports First Quarter Financial Results and Provides Corporate Update
“The first quarter of 2019 was Arvinas’ first quarter as a clinical-stage company and we remain laser-focused on moving our clinical and preclinical programs ahead,” said
Business Highlights and Recent Developments
- Began dosing patients in our first clinical trial, a Phase 1 clinical trial of ARV-110, which will evaluate the safety and tolerability of ARV-110 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on standard of care therapies. We anticipate preliminary data from the study in the second half of 2019 and believe ARV-110 is the first in a new class of targeted protein degraders to enter human clinical trials.
- Completed our initial public offering (IPO) in
October 2018, issuing an aggregate of 7,700,482 shares of common stock, including 200,482 additional shares of common stock upon the exercise, in part by the underwriters, of their option to purchase additional shares at a public offering price of $16.00 per share. The company received aggregate gross proceeds of approximately $123.2 million.
Anticipated Milestones and Expectations
- Present preliminary safety, tolerability and pharmacokinetic data from the Phase 1 clinical trial of ARV-110 in the second half of 2019.
- Initiate a Phase 1 clinical trial of ARV-471 in patients with locally advanced or metastatic ER-positive / HER2-negative breast cancer in the third quarter of 2019 and share preliminary clinical data in 2020.
- Discuss our neuroscience strategy and present preclinical data from our tau program in the second half of 2019.
Based on its current operating plan,
First Quarter Financial Highlights
Cash, Cash Equivalents, and Marketable Securities Position: As of
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Revenues: Revenue was
Net Loss: Net loss was $14.4 million for the quarter ended
ARV-110 is an orally-bioavailable PROTAC® protein degrader designed to selectively target and degrade androgen receptor protein (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.
ARV-471 is an orally-bioavailable PROTAC® protein degrader designed to target the estrogen receptor (ER) for the treatment of patients with locally-advanced or metastatic ER-positive / HER2-negative breast cancer. A Phase 1 clinical trial for ARV-471 in patients with locally-advanced or metastatic ER-positive / HER2-negative breast cancer is expected to begin in the third quarter of 2019 and preliminary clinical data is expected in 2020.
Arvinas is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies to 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. For more information, see www.arvinas.com.
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 our clinical trial for ARV-471, preliminary data from our clinical trial for ARV-110 and ARV-471 and preclinical data from our tau program, 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 a Phase 1 clinical trial for ARV-110, successfully initiate and conduct a Phase 1 clinical trial for ARV-471, complete other 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
|Consolidated Statement of Operations (Unaudited)|
|Quarter ended March 31,|
|Research and development||14,190,359||7,143,817|
|General and administrative||5,640,629||1,246,887|
|Total operating expenses||19,830,988||8,390,704|
|Loss from operations||(15,814,499||)||(4,282,108||)|
|Interest and other income||1,410,007||131,722|
|Change in fair value of redeemable convertible preferred units||—||(71,482,098||)|
|Net loss attributable to common shares/units||$||(14,404,492||)||$||(75,632,484||)|
|Net loss per common share/unit, basic and diluted||$||(0.46||)||$||(39.86||)|
|Weighted average common shares/units outstanding, basic and diluted||31,325,516||1,897,544|
|Consolidated Balance Sheet (Unaudited)|
|Cash and cash equivalents||$||28,786,247||$||3,190,056|
|Prepaid expenses and other current assets||2,304,852||2,818,286|
|Total current assets||179,735,878||195,677,779|
|Property, equipment and leasehold improvements, net||4,227,487||3,583,036|
|Operating lease right of use assets||2,584,002||—|
|Liabilities and stockholders' equity|
|Current portion of long-term debt||113,410||154,461|
|Current portion of operating lease liability||534,340||—|
|Total current liabilities||20,600,172||22,979,878|
|Long term debt, net of current portion||2,000,000||2,000,000|
|Operating lease liability||2,137,037||—|
|Other noncurrent liability||—||150,000|
|Commitments and Contingencies|
|Common stock, $0.001 par value; 31,368,864 and 31,235,458 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||31,369||31,236|
|Additional paid-in capital||444,295,404||439,118,089|
|Accumulated other comprehensive loss||80,031||(217,723||)|
|Total stockholders’ equity||127,737,693||136,666,983|
|Total liabilities and stockholders’ equity||$||186,568,127||$||199,281,575|
Source: Arvinas Inc.