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 second
quarter ended June 30, 2020 and provided a corporate update.
“We were pleased to report updated dose escalation data from our
Phase 1/2 trial of ARV-110 in men with metastatic
castration-resistant prostate cancer. These data demonstrated
safety and showed an early efficacy signal in a heavily pretreated
patient population, highlighting the potential benefit of our
PROTAC® platform. These data are a first for a targeted PROTAC®
protein degrader, and we are excited to report more mature data
from our ARV-110 program, and to announce interim data from our
ARV-471 Phase 1/2 trial, in the fourth quarter of 2020,” said John
Houston, Ph.D., President and Chief Executive Officer at
Arvinas.
“As we look to the balance of 2020, we are in a stronger
position than ever to lead the creation of an entirely new class of
therapies that targets and degrades disease-causing proteins,”
added Dr. Houston.
Business Highlights and Recent
Developments
- The company presented early efficacy and updated safety data
for ARV-110 at the 2020 American Society of Clinical Oncology
(ASCO) Annual Meeting. The data demonstrated that Arvinas’ PROTAC
protein degrader ARV-110 had an acceptable safety profile (as of
the data cut-off) and are the first to show early signs of clinical
efficacy for ARV-110 in a heavily pretreated patient
population.
- The company enhanced its Board of Directors with the
appointments of Linda Bain and Wendy Dixon, Ph.D.
Anticipated Milestones and Expectations
- For the ARV-110 program, Arvinas expects to provide an update
from its Phase 1/2 trial in the fourth quarter of 2020.
- For the ARV-471 program, Arvinas expects to share Phase 1 dose
escalation clinical data in the fourth quarter of 2020.
- Arvinas expects to provide information about the advancement of
additional programs in its robust preclinical pipeline 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 expenditures into
2022.
Financial Highlights
Cash, Cash Equivalents, and Marketable Securities
Position: As of June 30, 2020, cash, cash equivalents, and
marketable securities were $242.7 million as compared with $280.9
million as of December 31, 2019. The decrease in cash, cash
equivalents and marketable securities of $38.2 million for the
first six months of 2020 was primarily related to cash used for
operations of $43.2 million and the purchase of lab equipment
and lease hold improvements of $3.2 million, partially offset
by $4.0 million received from two collaborators, cash provided from
the exercise of stock options of $2.6 million and changes
in unrealized gain on marketable securities of $1.6
million.
Research and Development Expenses: Research and
development expenses were $23.4 million for the quarter ended June
30, 2020, as compared with $16.0 million for the quarter ended June
30, 2019. The increase in research and development expenses of $7.4
million for the quarter was primarily related to increases in
clinical trial and CMC expenses associated with our AR program of
$2.3 million and our ER program of $1.0 million, in addition to
increases in preclinical expenses of $4.1 million associated with
exploratory programs and investments in platform research.
General and Administrative Expenses: General
and administrative expenses were $8.8 million for the quarter ended
June 30, 2020, as compared to $6.4 million for the quarter ended
June 30, 2019. The increase of $2.4 million was primarily
related to an increase in personnel and facility related costs of
$2.2 million.
Revenues: Revenue was $5.7 million for the
quarter ended June 30, 2020, as compared with $4.0 million for the
quarter ended June 30, 2019. The increase of $1.7 million was
primarily related to the collaboration and license agreement with
Bayer that was initiated in July 2019. Revenues are 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.
Net Loss: Net loss was $25.2 million for the
quarter ended June 30, 2020, as compared with $17.2 million for the
quarter ended June 30, 2019. 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.
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 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, the conduct of and 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 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.
Arvinas, Inc. |
Consolidated Statement of Operations (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, |
|
For the Six Months Ended June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue |
|
$ |
5,747,681 |
|
|
$ |
4,016,489 |
|
|
$ |
11,987,309 |
|
|
$ |
8,032,979 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
23,416,090 |
|
|
|
16,000,638 |
|
|
|
45,142,776 |
|
|
|
30,190,996 |
|
General and administrative |
|
|
8,815,474 |
|
|
|
6,440,779 |
|
|
|
16,740,479 |
|
|
|
12,081,409 |
|
Total operating expenses |
|
|
32,231,564 |
|
|
|
22,441,417 |
|
|
|
61,883,255 |
|
|
|
42,272,405 |
|
Income (loss) from
operations |
|
|
(26,483,883 |
) |
|
|
(18,424,928 |
) |
|
|
(49,895,946 |
) |
|
|
(34,239,426 |
) |
Other income (expenses) |
|
|
|
|
|
|
|
|
Other income, net |
|
|
307,743 |
|
|
|
191,729 |
|
|
|
697,752 |
|
|
|
434,850 |
|
Interest income |
|
|
965,851 |
|
|
|
1,091,331 |
|
|
|
2,264,984 |
|
|
|
2,281,853 |
|
Interest expense |
|
|
(16,250 |
) |
|
|
(22,778 |
) |
|
|
(32,500 |
) |
|
|
(46,416 |
) |
Total other income |
|
|
1,257,344 |
|
|
|
1,260,282 |
|
|
|
2,930,236 |
|
|
|
2,670,287 |
|
Net loss |
|
$ |
(25,226,539 |
) |
|
$ |
(17,164,646 |
) |
|
$ |
(46,965,710 |
) |
|
$ |
(31,569,139 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.22 |
) |
|
$ |
(1.01 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
38,739,922 |
|
|
|
31,440,051 |
|
|
|
38,644,209 |
|
|
|
31,408,658 |
|
Arvinas, Inc. |
Consolidated Balance Sheet (Unaudited) |
|
|
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
21,593,656 |
|
|
$ |
9,211,057 |
|
Marketable securities |
|
|
221,103,306 |
|
|
|
271,661,456 |
|
Other receivables |
|
|
3,564,317 |
|
|
|
6,280,828 |
|
Prepaid expenses and other current assets |
|
|
3,320,609 |
|
|
|
3,727,294 |
|
Total current assets |
|
|
249,581,888 |
|
|
|
290,880,635 |
|
Property, equipment and leasehold
improvements, net |
|
|
10,541,408 |
|
|
|
8,455,411 |
|
Operating lease right of use
assets |
|
|
2,429,500 |
|
|
|
2,278,623 |
|
Other assets |
|
|
28,777 |
|
|
|
26,757 |
|
Total assets |
|
$ |
262,581,573 |
|
|
$ |
301,641,426 |
|
Liabilities and
stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
2,429,757 |
|
|
$ |
4,556,827 |
|
Accrued expenses |
|
|
7,404,460 |
|
|
|
7,602,904 |
|
Deferred revenue |
|
|
22,964,819 |
|
|
|
19,979,525 |
|
Current portion of operating lease liability |
|
|
920,765 |
|
|
|
673,896 |
|
Total current liabilities |
|
|
33,719,801 |
|
|
|
32,813,152 |
|
Deferred revenue |
|
|
27,489,590 |
|
|
|
38,427,882 |
|
Long term debt |
|
|
2,000,000 |
|
|
|
2,000,000 |
|
Operating lease liability |
|
|
1,590,758 |
|
|
|
1,714,111 |
|
Total liabilities |
|
|
64,800,149 |
|
|
|
74,955,145 |
|
Commitments and
Contingencies |
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Common stock, $0.001 par value; 38,825,190 and 38,461,353
shares issued and outstanding as of June 30, 2020 and
December 31, 2019, respectively |
|
|
38,825 |
|
|
|
38,461 |
|
Accumulated deficit |
|
|
(419,522,556 |
) |
|
|
(372,556,846 |
) |
Additional paid-in capital |
|
|
615,601,031 |
|
|
|
599,097,090 |
|
Accumulated other comprehensive income |
|
|
1,664,124 |
|
|
|
107,576 |
|
Total stockholders’ equity |
|
|
197,781,424 |
|
|
|
226,686,281 |
|
Total liabilities and
stockholders’ equity |
|
$ |
262,581,573 |
|
|
$ |
301,641,426 |
|
Contacts for Arvinas
InvestorsWill O’Connor, Stern Investor
Relations ir@arvinas.com
MediaKirsten Owens, Arvinas
Communications kirsten.owens@arvinas.com
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