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ARVN - Arvinas Inc News Story

$63.63 0.5  0.8%

Last Trade - 07/05/21

Sector
Healthcare
Size
Mid Cap
Market Cap £2.23bn
Enterprise Value £1.76bn
Revenue £15.2m
Position in Universe 1861st / 6854

Arvinas Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

Mon 1st March, 2021 12:00pm
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NEW HAVEN, Conn., March 01, 2021 (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 fourth quarter and full year ended December 31, 2020 and provided a
corporate update.

“2020 was a breakthrough year for Arvinas and for the patients we aim to
serve, as we reported clear signals of efficacy in both of our clinical-stage
programs. These data provided further validation that our approach to protein
degradation could potentially change the lives of patients with few or no
therapeutic options,” said John Houston, Ph.D., Chief Executive Officer at
Arvinas. “Despite the unprecedented circumstances of a pandemic, our
clinical trials and preclinical research continued to deliver, and we enter
2021 well positioned to extend our success and progress our programs in
oncology and neurodegeneration.”

Business Highlights and Recent Developments
* Presented interim Phase 1 data for ARV-471 showing potential for
best-in-class safety and tolerability, estrogen receptor (ER) degradation
greater than that previously reported for the current standard of care agent
(fulvestrant), and a robust efficacy signal in heavily pretreated patients
with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-)
breast cancer
* Presented data from the ongoing dose escalation portion of the Phase 1/2
trial of ARV-110 in men with metastatic castration-resistant prostate cancer
(mCRPC), providing additional evidence of anti-tumor activity and patient
benefit, including a prostate specific antigen reduction ≥50% (PSA50) in 2
of 5 (40%) in a molecularly defined patient population
* Closed an underwritten public offering of 6,571,428 shares of common stock
at a public offering price of $70.00 per share, including the exercise in full
by the underwriters of their option to purchase additional shares of common
stock. Arvinas received net proceeds of $431.9 million, after deducting
underwriting discounts and commissions and offering expenses
* Initiated the ARDENT Phase 2 dose expansion study of ARV-110 (Dose: 420 mg
daily)
* Initiated the VERITAC Phase 2 dose expansion study of ARV-471 (Dose: 200 mg
daily)
* Initiated a Phase 1b trial of ARV-471 in combination with Ibrance®
(palbociclib)
Anticipated Milestones and Expectations

ARV-471
* Completion of the Phase 1 dose escalation (1H21)
* Presentation of completed Phase 1 dose escalation data (2H21)
* Announcement of safety data from the Phase 1b trial in combination with
Ibrance® (palbociclib) (2H21)
* Initiation of a window of opportunity study in adjuvant breast cancer (2H21)
* Initiation of a combination trial of ARV-471 and another targeted therapy in
2L/3L metastatic breast cancer (2H21)
ARV-110
* Completion of the Phase 1 dose escalation (1H21)
* Presentation of completed Phase 1 dose escalation data (2H21)
* Announcement of interim data from the ARDENT Phase 2 dose expansion at 420
mg (2H21)
* Initiation of combination trial(s) with standards-of-care (2021)
Other Clinical Milestones
* Initiation of first-in-human study of ARV-766, an androgen receptor (AR)
degrader with a differentiated profile from ARV-110, in patients with
metastatic castration-resistant prostate cancer (1H21)
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 2024.

Full Year and Fourth Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities Position: As of December 31,
2020, cash, cash equivalents and marketable securities were $688.5 million as
compared with $280.9 million as of December 31, 2019. The increase primarily
related to net proceeds from the issuance of common stock and proceeds from
the exercise of stock options of $504.7 million, proceeds from two
collaborators of $7.4 million, partially offset by cash used to fund
operations of approximately $98.1 million and cash used to purchase fixed
assets and leasehold improvements of $6.4 million.

Research and Development Expenses: Research and development expenses were
$108.4 million and $33.2 million for the year and quarter ended December 31,
2020, respectively, as compared with $67.2 million and $20.4 million for the
year and quarter ended December 31, 2019, respectively. The increase in
research and development expenses for the year of $41.2 million primarily
related to Arvinas’ continued investment in its wholly owned platform,
exploratory and lead optimization programs of $17.6 million, its androgen
receptor (AR) program of $12.3 million and estrogen receptor program (ER) of
$11.3 million. The increase in research and development expense for the
quarter of $12.8 million primarily related to Arvinas’ continued investment
in its wholly owned platform, exploratory and lead optimization programs of
$5.1 million, its AR program of $4.8 million and ER program of $2.9 million.

General and Administrative Expenses: General and administrative expenses were
$38.3 million and $12.2 million for the year and quarter ended December 31,
2020, respectively, as compared with $27.3 million and $7.3 million for the
year and quarter ended December 31, 2019, respectively. The increase in
general and administrative expenses for the year of $11.0 million related to
an increase of $9.6 million in personnel and facility related costs, including
$4.8 million related to stock compensation expense, and insurance, taxes and
professional fees of $1.4 million. The increase in general and administrative
expenses for the quarter of $5.0 million primarily related to an increase of
$2.9 in personnel and facility cost, including $1.4 million related to stock
compensation expense and $1.7 million of legal and other professional
services.

Revenues: Revenues were $21.8 million and $2.2 million for the year and
quarter ended December 31, 2020, respectively, as compared with $43.0 million
and $4.9 million for the year and quarter ended December 31, 2019,
respectively. Revenue for the year ended December 31, 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
collaboration revenue of $18.3 million and revenue of $4.9 million for the
year and quarter ended December 31, 2019, respectively, 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. The increase in collaboration revenue of $3.5 million for the
year was primarily related to the Bayer agreement having only a partial year
of revenue recognized in 2019 and an increase in activities related to the
Pfizer agreement. The decrease in collaboration revenue of $2.7 million in the
quarter primarily related to a collaborator adding new targets that extended
the period of revenue recognition for the collaboration agreement.   

Loss from Equity Method Investment: Loss from equity method investment for the
year ended December 31, 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 $119.3 million and $41.5 million for the year and
quarter ended December 31, 2020, respectively, as compared with $70.3 million
and $21.0 million for the year and quarter ended December 31, 2019,
respectively. The increase in net loss for the year and quarter ended December
31, 2020 of $49.0 million and $20.5 million, respectively, primarily related
to Arvinas’ continued investment in its platform, exploratory and lead
optimization programs, its AR program, its ER program, and an increase in
general and administrative infrastructure costs.

About ARV-110
ARV-110 is an investigational 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.

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 investigational 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
PROTAC® Discovery Engine 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. In addition to its robust
preclinical pipeline of PROTAC® protein degraders against validated and
“undruggable” targets, the company has two clinical-stage programs:
ARV-110 for the treatment of men 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, including the
timing of initiation or completion of or availability 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, conduct a Phase 1 clinical trial of
ARV-766 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 release.

Contacts for Arvinas

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

Media
Kirsten Owens, Arvinas Communications
kirsten.owens@arvinas.com

 Arvinas, Inc.                                                                                                                                                             
 Consolidated Statement of Operations (Unaudited)                                                                                                                          
                                                                                                                                                                           
                                                                Quarter Ended December 31,                              Year Ended December 31,                            
                                                                      2020                     2019                           2020                      2019               
 Revenue                                                        $     2,217,692          $     4,893,273                $     21,801,777          $     42,976,478         
 Operating expenses:                                                                                                                                                       
 Research and development                                             33,200,159               20,414,783                     108,355,853               67,193,830         
 General and administrative                                           12,230,997               7,268,390                      38,303,401                27,307,162         
 Total operating expenses                                             45,431,156               27,683,173                     146,659,254               94,500,992         
 Loss from operations                                                 (43,213,464  )           (22,789,900  )                 (124,857,477  )           (51,524,514  )     
 Interest and other income                                            1,666,976                1,742,184                      5,525,413                 5,907,287          
 Loss from equity method investment                                   —                        —                              —                         (24,675,000  )     
 Net loss                                                             (41,546,488  )           (21,047,716  )                 (119,332,064  )           (70,292,227  )     
 Net loss per common share, basic and diluted                         (0.99        )     $     (0.56        )                 (3.02         )           (2.13        )     
 Weighted average common shares outstanding, basic and diluted        41,767,980               37,338,484                     39,534,497                32,927,697         
                                                                                                                                                                           



 Arvinas, Inc.                                                                                                                                                                            
 Consolidated Balance Sheet (Unaudited)                                                                                                                                                   
                                                                                                                                                                                          
                                                                                                                                         December 31,                                     
                                                                                                                                             2020                       2019              
 Assets                                                                                                                                                                                   
 Current assets:                                                                                                                                                                          
 Cash and cash equivalents                                                                                                               $   588,373,232            $   9,211,057         
 Marketable securities                                                                                                                       100,157,618                271,661,456       
 Account receivable                                                                                                                          1,000,000                  —                 
 Other receivables                                                                                                                           7,443,654                  6,280,828         
 Prepaid expenses and other current assets                                                                                                   6,113,122                  3,727,294         
 Total current assets                                                                                                                        703,087,626                290,880,635       
 Property, equipment and leasehold improvements, net                                                                                         12,259,515                 8,455,411         
 Operating lease right of use assets                                                                                                         1,992,669                  2,278,623         
 Other assets                                                                                                                                28,777                     26,757            
 Total assets                                                                                                                            $   717,368,587            $   301,641,426       
 Liabilities and stockholders' equity                                                                                                                                                     
 Current liabilities:                                                                                                                                                                     
 Accounts payable                                                                                                                        $   7,121,879              $   4,556,827         
 Accrued expenses                                                                                                                            18,859,840                 7,602,904         
 Deferred revenue                                                                                                                            22,150,861                 19,979,525        
 Current portion of operating lease liabilities                                                                                              952,840                    673,896           
 Total current liabilities                                                                                                                   49,085,420                 32,813,152        
 Deferred revenue                                                                                                                            22,938,233                 38,427,882        
 Long term debt, net of current portion                                                                                                      2,000,000                  2,000,000         
 Operating lease liabilities                                                                                                                 1,087,422                  1,714,111         
 Total liabilities                                                                                                                           75,111,075                 74,955,145        
 Commitments and contingencies                                                                                                                                                            
 Stockholders' equity:                                                                                                                                                                    
 Common stock, $0.001 par value, 48,455,741 and 38,461,353 shares issued and outstanding as of December 31, 2020 and 2019, respectively      48,455                     38,461            
 Accumulated deficit                                                                                                                         (491,888,910   )           (372,556,846  )   
 Additional paid-in capital                                                                                                                  1,133,537,171              599,097,090       
 Accumulated other comprehensive income                                                                                                      560,796                    107,576           
 Total stockholders' equity                                                                                                                  642,257,512                226,686,281       
 Total liabilities and stockholders' equity                                                                                              $   717,368,587            $   301,641,426       
                                                                                                                                                                                          

 

 

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