Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology
company creating a new class of drugs based on targeted protein
degradation, today reported financial results for the third quarter
ended September 30, 2021 and provided a corporate update.
“The team at Arvinas has made a number of significant
achievements throughout the year, from initiating multiple clinical
trials to completing a potentially transformational collaboration
with Pfizer, further establishing our leadership position in the
field of targeted protein degradation,” said John Houston, Ph.D.,
chief executive officer at Arvinas. “We believe the upcoming
presentation of data from the completed Phase 1 dose escalation
study with ARV-471 for the treatment of patients with locally
advanced or metastatic ER+/HER2- breast cancer sets us up for a
strong finish to what so far has been an important year of
execution.”
“As we look ahead, our collaboration with Pfizer has enabled us
to further evaluate the most efficient development pathway for
ARV-471,” continued Dr. Houston. “In addition to initiating
multiple planned Phase 3 studies with ARV-471 in 2022, we now
intend to initiate the Phase 1b combination study with everolimus,
potentially as part of a planned umbrella study with multiple
combination agents with Pfizer, as well as the neoadjuvant study,
in 2022. Additionally, we expect to present the full dose
escalation data from the ARV-110 Phase 1 trial and an interim
readout from the ARDENT Phase 2 expansion trial at ASCO
Genitourinary Cancers Symposium in February 2022, an opportunity to
showcase a more complete picture of the potential of ARV-110 in
metastatic castration-resistant prostate cancer.”
Business Highlights and Recent Developments
- Initiated Phase 1b combination trial with ARV-110 and
abiraterone for the treatment of metastatic castration-resistant
prostate cancer (mCRPC).
- Completed global collaboration with Pfizer that included an
upfront payment to Arvinas of $650 million, a $350 million equity
investment from Pfizer, and $1.4 billion in potential milestone
payments to co-develop and co-commercialize ARV-471 to the
treatment of patients with ER+ breast cancer. Arvinas and Pfizer
will equally share worldwide development costs, commercialization
expenses, and profits.
Anticipated Milestones and Expectations
ARV-471
- Present Phase 1 dose escalation trial data (San Antonio Breast
Cancer Symposium, December 2021)
- Present data from the VERITAC Phase 2 expansion trial (200 and
500 mg) (2022)
- Present safety data from the Phase 1b combination study with
palbociclib (2022)
- Initiate multiple Phase 3 trials in metastatic breast cancer
(as monotherapy and in combination) (2022)
- Initiate Phase 1b combination trial with everolimus in 2L/3L
metastatic breast cancer, potentially as part of a planned umbrella
study with Pfizer to explore multiple combination agents
(2022)
- Initiate Phase 2 neoadjuvant trial in early breast cancer
(2022)
ARV-110
- Present completed Phase 1 dose escalation data at ASCO
Genitourinary Cancers Symposium (February 2022)
- Present interim data from the ARDENT Phase 2 dose expansion
(420 mg) at ASCO Genitourinary Cancers Symposium (February
2022)
ARV-766
- Announce Phase 1 dose escalation data in mCRPC (2022)
- Initiate Phase 2 expansion trial in mCRPC (2022)
Third Quarter Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable
Securities Position: As of September 30, 2021, cash,
cash equivalents, restricted cash and marketable securities were
$1,549.0 million as compared with $688.5 million as of December 31,
2020. The increase in cash, cash equivalents, restricted cash and
marketable securities of $860.5 million for the first nine months
of 2021 was primarily related to cash received from the global
Pfizer collaboration agreement to develop and commercialize ARV-471
(ARV-471 Collaboration Agreement) of $650.0 million, the equity
investment by Pfizer of $350.0 million and proceeds from the
exercise of stock options of $14.7 million, partially offset by
cash used in operating activities of $133.9 million (net of $4.2
million received from two collaborators), professional fees
associated with the global Pfizer collaboration and equity
investment of $17.5 million, and the purchase of lab equipment and
leasehold improvements of $2.8 million.
Research and Development
Expenses: Research and development expenses were
$40.6 million for the quarter ended September 30, 2021, as compared
with $30.0 million for the quarter ended September 30, 2020. The
increase in research and development expenses of $10.6 million for
the quarter was primarily due to an increase in our continued
investment in our platform and exploratory programs of $9.0 million
and an increase in expenses related to our AR program (which
includes ARV-110 and ARV-766) of $3.5 million, partially offset by
a decrease in our ER program of $1.9 million, which includes the
cost sharing of ARV-471 under the ARV-471 Collaboration Agreement
with Pfizer.
General and Administrative
Expenses: General and administrative expenses were
$16.0 million for the quarter ended September 30, 2021, as compared
with $9.3 million for the quarter ended September 30, 2020. The
increase of $6.7 million was primarily due to an increase in
personnel and facility related costs of $5.0 million and insurance
and professional fees of $1.7 million.
Revenues: Revenues were $9.3 million for the
quarter ended September 30, 2021 as compared to $7.6 million for
the quarter ended September 30, 2020. Revenue is related to the
ARV-471 Collaboration Agreement with Pfizer that was initiated in
July 2021, 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 revenues of $1.7 million was
primarily due to revenue from the ARV-471 Collaboration Agreement
with Pfizer, partially offset by the addition of new targets added
in 2020 under the January 2018 Pfizer Collaboration Agreement
extending the revenue recognition period.Net
Loss: Net loss was $46.8 million for the quarter
ended September 30, 2021, as compared with $30.8 million for the
quarter ended September 30, 2020. The increase in net loss for the
quarter was primarily due to increased research and development
expenses and increased general and administrative expenses,
partially offset by increased revenue.
About ARV-110ARV-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-471ARV-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 ARV-766ARV-766 is an investigational
orally bioavailable PROTAC® protein degrader designed to
selectively target and degrade AR. In preclinical studies, ARV-766
degraded all resistance-driving point mutations of AR, including
L702H, a mutation associated with treatment with abiraterone and
other AR-pathway therapies.
ARV-766 is being developed as a potential treatment for men with
metastatic castration-resistant prostate cancer, and ARV-766 may
also have applicability in other AR-driven diseases both in and
outside oncology. ARV-766 has demonstrated activity in preclinical
models of resistance to currently available AR-targeted
therapies.
About ArvinasArvinas 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 three clinical-stage
programs: ARV-110 and ARV-766 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 StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements regarding the potential
benefits of the collaboration and the potential advantages and
therapeutic benefits of ARV-471, ARV-110, ARV-766 and our other
product candidates, the future development and potential marketing
approval and commercialization of ARV-471, ARV-110, ARV-766 and our
other product candidates, including the timing of data from and
initiation of our clinical trials. 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: each party’s performance of its
obligations under the Pfizer collaboration, whether we and, as
applicable, Pfizer will be able to successfully conduct and
complete clinical development, including whether we receive results
from our clinical trials on our expected timelines or at all,
obtain marketing approval for and commercialize ARV-471, ARV-110,
ARV-766 and our other product candidates on our current timelines
or at all 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.
Investor Contact:Jeff Boyle (347)
247-5089jeff.boyle@arvinas.com
Media Contact:Kirsten Owens(203)
584-0307kirsten.owens@arvinas.com
Arvinas, Inc. |
Consolidated Balance Sheet (Unaudited) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
255,662,835 |
|
|
$ |
588,373,232 |
|
Restricted cash |
|
4,500,000 |
|
|
|
— |
|
Marketable securities |
|
1,288,814,399 |
|
|
|
100,157,618 |
|
Accounts receivable |
|
1,880,180 |
|
|
|
1,000,000 |
|
Other receivables |
|
6,755,720 |
|
|
|
7,443,654 |
|
Prepaid expenses and other current assets |
|
18,537,587 |
|
|
|
6,113,122 |
|
Total current assets |
|
1,576,150,721 |
|
|
|
703,087,626 |
|
Property, equipment and leasehold improvements, net |
|
11,628,051 |
|
|
|
12,259,515 |
|
Operating lease right of use assets |
|
4,250,463 |
|
|
|
1,992,669 |
|
Collaboration contract asset and other assets |
|
12,835,975 |
|
|
|
28,777 |
|
Total assets |
$ |
1,604,865,210 |
|
|
$ |
717,368,587 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,671,605 |
|
|
$ |
7,121,879 |
|
Accrued expenses |
|
13,769,220 |
|
|
|
18,859,840 |
|
Deferred revenue |
|
162,943,830 |
|
|
|
22,150,861 |
|
Current portion of operating lease liabilities |
|
1,123,101 |
|
|
|
952,840 |
|
Total current liabilities |
|
182,507,756 |
|
|
|
49,085,420 |
|
Deferred revenue |
|
600,429,165 |
|
|
|
22,938,233 |
|
Long term debt |
|
1,000,000 |
|
|
|
2,000,000 |
|
Operating lease liability |
|
3,191,132 |
|
|
|
1,087,422 |
|
Total liabilities |
|
787,128,053 |
|
|
|
75,111,075 |
|
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock, $0.001 par value; 52,766,020 and 48,455,741 shares
issued and outstanding as of September 30, 2021 and December 31,
2020, respectively |
|
52,766 |
|
|
|
48,455 |
|
Accumulated deficit |
|
(629,893,515 |
) |
|
|
(491,888,910 |
) |
Additional paid-in capital |
|
1,448,254,555 |
|
|
|
1,133,537,171 |
|
Accumulated other comprehensive (loss) income |
|
(676,649 |
) |
|
|
560,796 |
|
Total stockholders' equity |
|
817,737,157 |
|
|
|
642,257,512 |
|
Total liabilities and stockholders' equity |
$ |
1,604,865,210 |
|
|
$ |
717,368,587 |
|
Arvinas, Inc. |
Consolidated Statement of Operations (Unaudited) |
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
Revenue |
$ |
9,284,785 |
|
$ |
7,596,776 |
|
|
$ |
20,368,568 |
|
$ |
19,584,085 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
40,603,631 |
|
|
30,012,918 |
|
|
|
118,481,320 |
|
|
75,155,694 |
|
General and administrative |
|
16,012,384 |
|
|
9,331,925 |
|
|
|
42,741,962 |
|
|
26,072,404 |
|
Total operating expenses |
|
56,616,015 |
|
|
39,344,843 |
|
|
|
161,223,282 |
|
|
101,228,098 |
|
Loss from operations |
|
(47,331,230 |
) |
|
(31,748,067 |
) |
|
|
(140,854,714 |
) |
|
(81,644,013 |
) |
Interest and other income |
|
579,478 |
|
|
928,201 |
|
|
|
2,850,109 |
|
|
3,858,437 |
|
Net loss |
$ |
(46,751,752 |
) |
$ |
(30,819,866 |
) |
|
$ |
(138,004,605 |
) |
$ |
(77,785,576 |
) |
Net loss per common share, basic and diluted |
$ |
(0.94 |
) |
$ |
(0.79 |
) |
|
$ |
(2.81 |
) |
$ |
(2.01 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
49,807,508 |
|
|
39,058,294 |
|
|
|
49,101,927 |
|
|
38,784,569 |
|
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