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CST: 12/11/2019 00:46:07   

Arvinas Reports Third Quarter 2019 Financial Results and Provides Corporate Update

7 Days ago

NEW HAVEN, Conn., Nov. 04, 2019 (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 third quarter of 2019 and provided a corporate update.

“We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs. In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC® protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our PROTAC® platform,” said John Houston, Ph.D., Chief Executive Officer of Arvinas. “We look forward to the continued progress of our lead programs and pipeline, and ultimately to making a difference in the lives of patients.”

Business Highlights and Recent Developments

  • Presented initial data from the company’s ongoing Phase 1 clinical trials of ARV-110 and ARV-471. The initial data showed dose proportionality for ARV-110 and that exposures of both ARV-110 and ARV-471 have reached levels associated with tumor growth inhibition in preclinical studies. In addition, both ARV-110 and ARV-471, at each dose tested to date, were well tolerated, with no dose-limiting toxicities and no observed grade 2, 3, or 4 adverse events related to treatment.
  • Presented preclinical data from the company’s alpha-synuclein (a-synuclein)-targeted PROTAC® protein degrader program. The data showed that the company has created a-synuclein-targeted degraders that degrade oligomeric a-synuclein. In addition, the company has created a-synuclein-targeting PROTAC® protein degraders that cross the blood-brain barrier following parenteral (peripheral) administration.
  • Announced that six new oncology and neurology thought leaders in the areas of oncology and neurological disorders have joined the company’s scientific advisory board (SAB). The new members are Tomasz M. Beer, M.D., F.A.C.P., Adam L. Boxer, M.D., Ph.D., Sara Courtneidge, Ph.D., Lennart Mucke, M.D., Benjamin G. Neel, M.D., Ph.D., and Lillian L. Siu, M.D. For full details on our new SAB members, visit www.arvinas.com.
  • Initiated patient dosing in its ongoing Phase 1 clinical trial of ARV-471, which is evaluating the safety, tolerability, and pharmacokinetics of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer.

Anticipated Milestones and Expectations

  • For the ARV-110 program, Arvinas expects to next share completed Phase 1 dose escalation clinical data in the first half of 2020.
  • For the ARV-471 program, Arvinas expects to next share clinical data in the second half of 2020.

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 expenditure requirements into the second half of 2021.

Financial Highlights

Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2019, cash, cash equivalents, and marketable securities were $190.5 million as compared to $187.8 million as of December 31, 2018. The increase in cash, cash equivalents and marketable securities of $2.7 million in the first nine months of 2019 primarily related to aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer, partially offset by the purchase of lab equipment and leasehold improvements of $4.5 million and cash used to fund operations of $49.7 million. 

Research and Development Expenses: Research and development expenses were $16.6 million for the quarter ended September 30, 2019, as compared to $13.1 million for the quarter ended September 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with our ongoing Phase 1 clinical trial of ARV-110 and the initiation of our Phase 1 clinical trial of 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 $8.0 million for the quarter ended September 30, 2019, as compared to $4.3 million for the quarter ended September 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 $30.1 million for the quarter ended September 30, 2019, as compared to $3.4 million for the quarter ended September 30, 2018. Revenue for the quarter ended September 30, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC® technology in agricultural applications (the “Joint Venture”). The remaining revenue of $5.4 million for the quarter 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.

Loss from Equity Method Investment: Loss from equity method investment for the quarter ended September 30, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture’s expensing the values associated with the contributed intellectual property from the Joint Venture partners.

Net Loss: Net loss was $17.7 million for the quarter ended September 30, 2019, as compared to $13.4 million for the quarter ended September 30, 2018. The increased revenue that related to the Joint Venture was offset by the loss from equity method investment in the Joint Venture for the quarter ended September 30, 2019 and as such, the increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses. 

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). 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. 

About ARV-471
ARV-471 is a PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic 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 as a single agent and in combination with a CDK4/6 inhibitor when compared to a standard of care agent, fulvestrant (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 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, such as the timing of our clinical trials for ARV-110 and ARV-471 and data from those clinical trials, 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 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

Investors
Will O’Connor, Stern Investor Relations
ir@arvinas.com

Media
Cory Tromblee, ScientPR
pr@arvinas.com

 
Arvinas, Inc.
Consolidated Statement of Operations (Unaudited)
               
  For the Three Months Ended
September 30,
  For the Nine Months Ended
September 30,
    2019       2018       2019       2018  
Revenue $ 30,050,227     $ 3,375,264     $ 38,083,205     $ 10,883,755  
Operating expenses:              
Research and development   16,588,050       13,149,879       46,779,047       30,631,531  
General and administrative   7,957,364       4,284,231       20,038,772       7,110,723  
Total operating expenses   24,545,414       17,434,110       66,817,819       37,742,254  
Income (loss) from operations   5,504,813       (14,058,846 )     (28,734,614 )     (26,858,499 )
Other income (expenses)              
Other income, net   405,302       160,100       840,153       418,494  
Change in fair value of preferred unit warrant                     (193,779 )
Interest income   1,112,415       523,338       3,394,269       1,273,988  
Interest expense   (22,903 )     (12,264 )     (69,319 )     (32,804 )
Total other income   1,494,814       671,174       4,165,103       1,465,899  
Loss from equity method investment   (24,675,000 )           (24,675,000 )      
Net loss   (17,675,373 )     (13,387,672 )     (49,244,511 )     (25,392,600 )
Change in fair value of redeemable convertible preferred units         (112,050,609 )           (198,366,756 )
Net loss attributable to common shares $ (17,675,373 )   $ (125,438,281 )   $ (49,244,511 )   $ (223,759,356 )
Net loss per common share, basic and diluted $ (0.54 )   $ (62.38 )   $ (1.54 )   $ (115.62 )
Weighted average common shares outstanding, basic and diluted   32,740,486       2,010,807       31,876,074       1,935,299  
                               


Arvinas, Inc.
Consolidated Balance Sheet (Unaudited)
       
  September 30,
2019
  December 31,
2018
Assets      
Current assets:      
Cash and cash equivalents $ 12,135,475     $ 3,190,056  
Marketable securities   178,375,159       184,637,640  
Account receivable   59,330       2,775,831  
Other receivables   5,142,227       2,255,966  
Prepaid expenses and other current assets   3,951,152       2,818,286  
Total current assets   199,663,343       195,677,779  
Property, equipment and leasehold improvements, net   7,152,151       3,583,036  
Operating lease right of use assets   2,257,544        
Other assets   20,760       20,760  
Total assets $ 209,093,798     $ 199,281,575  
Liabilities and stockholders' equity      
Current liabilities:      
Accounts payable $ 2,277,824     $ 2,758,184  
Accrued expenses   6,226,971       4,001,276  
Deferred revenue   20,294,456       16,065,957  
Current portion of long-term debt         154,461  
Current portion of operating lease liability   597,014        
Total current liabilities   29,396,265       22,979,878  
Deferred revenue   41,770,160       37,484,714  
Long term debt, net of current portion   2,000,000       2,000,000  
Operating lease liability   1,767,775        
Other noncurrent liability         150,000  
Total liabilities   74,934,200       62,614,592  
Commitments and Contingencies      
Stockholders’ equity:      
Common stock, $0.001 par value; 33,076,557 and 31,235,458 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively   33,076       31,236  
Accumulated deficit   (351,509,130 )     (302,264,619 )
Additional paid-in capital   485,439,007       439,118,089  
Accumulated other comprehensive income (loss)   196,645       (217,723 )
Total stockholders’ equity   134,159,598       136,666,983  
Total liabilities and stockholders’ equity $ 209,093,798     $ 199,281,575  
       

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