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NEW HAVEN, Conn., Aug. 05, 2019 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter of 2019 and provided a corporate update.
“We made significant progress throughout the first half of 2019, highlighted by both clinical and corporate advances. We initiated first-in-human studies with ARV-110 in metastatic castration-resistant prostate cancer and received Fast Track designation from the U.S. Food and Drug Administration (FDA) for this indication. The FDA also cleared our IND for ARV-471 in ER positive/HER2 negative breast cancer,” said John Houston, Ph.D., Chief Executive Officer of Arvinas. “The potential of our targeted protein degrader technology was further validated by our agreement with Bayer, which expands the application of our technology beyond human health and therapeutics to include agricultural applications.”
“In addition, we greatly enhanced our leadership strength with the addition of Ronald Peck, M.D., as our Chief Medical Officer and with the appointment of Leslie Norwalk, Esq., to our Board of Directors. Both are experienced executives with significant and relevant experience that will be instrumental in guiding Arvinas forward with a new class of drugs based on our proprietary targeted protein degradation platform,” added Dr. Houston.
Business Highlights and Recent Developments
Anticipated Milestones and Expectations
Based on its current operating plan, Arvinas expects its cash, cash equivalents, marketable securities and proceeds from Bayer will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2021.
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2019, cash, cash equivalents, and marketable securities were $159.2 million as compared to $187.8 million as of December 31, 2018. These amounts exclude proceeds from the private placement and collaboration agreement with Bayer, which closed on July 16, 2019 and will provide an additional $51.5 million. The decrease in cash, cash equivalents and marketable securities of $28.6 million in the first six months of 2019 was primarily related to net cash used in operating activities of $26.3 million, the purchase of lab equipment and lease hold improvements of $3.3 million partially offset by net cash provided by financing activities of $0.3 million and changes in unrealized gain on marketable securities of $0.5 million. During the six months ended June 30, 2019 we received $2.7 million from a collaborator and $1.0 million related to the exchange of research and development tax credits with the State of Connecticut. Our cash used to fund operations for the six months ended June 30, 2019 was $33.3 million.
Research and Development Expenses: Research and development expenses were $16.0 million for the quarter ended June 30, 2019, as compared to $10.3 million for the quarter ended June 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with the initiation of our Phase 1 clinical trial of ARV-110 and IND-enabling expenses associated with ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory programs research.
General and Administrative Expenses: General and administrative expenses were $6.4 million for the quarter ended June 30, 2019, as compared to $1.6 million for the quarter ended June 30, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming a public company in the fourth quarter of 2018.
Revenues: Revenue was $4.0 million for the quarter ended June 2019, as compared to $3.4 million for the quarter ended June 30, 2018. Revenues are generated from the license and rights to technology fees and research and development activities related to 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.
Net Loss: Net loss was $17.2 million for the quarter ended June 30, 2019, as compared to $7.9 million for the quarter ended June 30, 2018. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.
ARV-110 is an orally-bioavailable PROTAC® protein degrader designed to selectively target and degrade the 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. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative mechanism of action, has the potential to translate into improved clinical outcomes for patients. Arvinas expects to present preliminary clinical data regarding ARV-110 in the fourth quarter of 2019, and to present additional clinical data for the Phase 1 trial in the first half of 2020.
ARV-471 is an orally-bioavailable PROTAC® protein degrader designed to target the estrogen receptor protein (ER). 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 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 disease-causing proteins. The company’s lead program, ARV-110 for the treatment of patients with metastatic castration-resistant prostate cancer, began a Phase 1 clinical trial in the first quarter of 2019. 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, and data from our clinical trial for ARV-110 and ARV-471 and the potential advantages and therapeutic potential of our product candidates, the sufficiency of cash resources, whether the pharmaceutical collaboration with Bayer will yield any viable product candidates, and the potential benefits of the Bayer collaboration and joint venture in the human therapeutic and agricultural fields, respectively. 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 on our expected timelines, or at all, each party’s ability to perform its obligations under the Bayer collaboration and/or the joint venture, 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
Will O’Connor, Stern Investor Relations
Cory Tromblee, ScientPR
|Consolidated Statement of Operations (Unaudited)|
For the Three Months
Ended June 30,
For the Six Months
Ended June 30,
|Research and development||16,000,638||10,337,835||30,190,996||17,481,652|
|General and administrative||6,440,779||1,579,605||12,081,409||2,826,492|
|Total operating expenses||22,441,417||11,917,440||42,272,405||20,308,144|
|Loss from operations||(18,424,928||)||(8,517,545||)||(34,239,426||)||(12,799,653||)|
|Other income (expenses)|
|Other income, net||191,729||130,945||434,850||258,394|
|Change in fair value of preferred unit warrant||—||2,516||—||(193,779||)|
|Total other income||1,260,282||663,003||2,670,287||794,725|
|Change in fair value of redeemable convertible preferred units||—||(14,834,049||)||—||(86,316,147||)|
|Net loss attributable to common shares/units||$||(17,164,646||)||$||(22,688,591||)||$||(31,569,139||)||$||(98,321,075||)|
|Net loss per common share/unit, basic and diluted||$||(0.55||)||$||(11.96||)||$||(1.01||)||$||(51.81||)|
|Weighted average common shares/units outstanding, basic and diluted||31,440,051||1,897,544||31,408,658||1,897,544|
|Consolidated Balance Sheet (Unaudited)|
|Cash and cash equivalents||$||11,342,178||$||3,190,056|
|Prepaid expenses and other current assets||2,685,820||2,818,286|
|Total current assets||163,261,088||195,677,779|
|Property, equipment and leasehold improvements, net||6,366,491||3,583,036|
|Operating lease right of use assets||2,397,789||—|
|Liabilities and stockholders' equity|
|Current portion of long-term debt||71,499||154,461|
|Current portion of operating lease liability||647,872||—|
|Total current liabilities||20,945,773||22,979,878|
|Long term debt, net of current portion||2,000,000||2,000,000|
|Operating lease liability||1,893,359||—|
|Other noncurrent liability||—||150,000|
|Commitments and Contingencies|
|Common stock, $0.001 par value; 31,523,474 and 31,235,458 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively||31,524||31,236|
|Additional paid-in capital||450,007,344||439,118,089|
|Accumulated other comprehensive income (loss)||300,150||(217,723||)|
|Total stockholders’ equity||116,505,260||136,666,983|
|Total liabilities and stockholders’ equity||$||172,046,128||$||199,281,575|