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
ended September 30, 2020 and provided a corporate update.
“Beginning the Phase 2 portion of the ARV-110 clinical trial
marks another significant milestone for Arvinas,” said John
Houston, Ph.D., President and Chief Executive Officer at Arvinas.
“Together with the expected initiation of a cohort expansion of
ARV-471 in combination with a CDK4/6 inhibitor before the end of
the year, we’re gratified by the strong momentum of our lead
programs heading into 2021.”
“When combined with our recent disclosure of five additional
programs in our preclinical pipeline, these clinical milestones
further validate our PROTAC® Discovery Engine and the opportunity
to create PROTAC® degraders that meaningfully improve patient
care,” added Dr. Houston.
Business Highlights and Recent Developments
- Dose escalation in each of the Phase 1/2 clinical trials of
ARV-110 and ARV-471 continues.
- Arvinas has initiated dosing at a first dose level in a Phase 2
cohort expansion for ARV-110.
- The company announced platform updates and disclosed five
additional programs from its preclinical pipeline. Arvinas’
portfolio encompasses a range of validated and undruggable targets
in oncology, immuno-oncology, and neuroscience. The newly disclosed
programs were B-cell lymphoma 6 protein (BCL6), Kirsten rat sarcoma
(KRAS) protein, c-Myc, hematopoietic progenitor kinase 1 (HPK1),
and mutant huntingtin (mHTT).
- Arvinas entered into a collaboration and supply agreement with
Pfizer in connection with a planned Phase 1b cohort expansion
evaluating ARV-471 in combination with Pfizer’s Ibrance®
(palbociclib), an oral CDK4/6 inhibitor.
Anticipated Milestones and Expectations
2020 Milestones and Expectations
- Arvinas expects to provide a program update for ARV-110,
including a Phase 1 dose escalation update and an overview of the
recently initiated Phase 2 dose expansion, in December 2020.
- For the ARV-471 program, Arvinas expects to provide an update
from its Phase 1 dose escalation in December 2020.
- Arvinas expects to initiate a Phase 1b cohort expansion of
ARV-471 in combination with Ibrance® (palbociclib) in the fourth
quarter of 2020. The study will evaluate the safety and
tolerability of ARV-471 in combination with palbociclib and
identify the recommended combination dose of ARV-471 for use with
palbociclib.
2021 Milestones and Expectations
- Arvinas expects to initiate the first of potentially two Phase
1b investigations of ARV-110 in combination with standard of care
agents for mCRPC (e.g., abiraterone) in 2021.
- Arvinas expects to share interim data from the Phase 2 dose
expansion trial of ARV-110 in 2021.
- Arvinas expects to initiate a Phase 2 dose expansion of ARV-471
in 2021.
- Arvinas expects to share data from the Phase 1b cohort
expansion of ARV-471 in combination with Ibrance® (palbociclib) in
the second half of 2021.
- Arvinas expects to file an investigational new drug (IND)
application for ARV-766, an androgen receptor degrader, in the
first half of 2021.
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 September 30, 2020, cash, cash
equivalents, and marketable securities were $248.6 million as
compared with $280.9 million as of December 31, 2019. The decrease
in cash, cash equivalents and marketable securities of $32.3
million for the first nine months of 2020 was primarily related to
cash used for operations of $64.8 million and the purchase of
lab equipment and leasehold improvements of $4.6 million,
partially offset by net proceeds from the issuance of common stock
and exercises of stock options of $33.1 million and $4.0 million
received from two collaborators.
Research and Development Expenses: Research and
development expenses were $30.0 million for the quarter ended
September 30, 2020, as compared with $16.6 million for the quarter
ended September 30, 2019. The increase in research and development
expenses of $13.4 million for the quarter was primarily related to
increases in clinical trials and chemistry, manufacturing and
controls expenses associated with our AR program of $4.2 million
and our ER program of $5.1 million, in addition to increases in
expenses of $4.1 million associated with exploratory programs and
investments in platform research.
General and Administrative Expenses: General
and administrative expenses were $9.3 million for the quarter ended
September 30, 2020, as compared with $8.0 million for the quarter
ended September 30, 2019. The increase of $1.3 million was
primarily related to an increase in personnel and facility related
costs of $2.4 million, offset by a reduction in legal costs of $1.1
million.
Revenues: Revenue related to the license and
rights to technology fees and research and development activities
related to the collaboration and license agreement with Bayer
(Bayer Collaboration Agreement) that was initiated in July
2019, the collaboration and license agreement with Pfizer (Pfizer
Collaboration Agreement) that was initiated in January 2018,
and the amended and restated option, license and collaboration
agreement with Genentech that was initiated in November 2017
(collectively Collaboration Revenue) was $7.6 million for the
quarter ended September 30, 2020, as compared with $5.4 million for
the quarter ended September 30, 2019. The increase in Collaboration
Revenue of $2.2 million primarily related to the revenues from the
Bayer Collaboration Agreement and the Pfizer Collaboration
Agreement. Total revenue of $30.1 for the three months ended
September 30, 2019 included $24.7 million for the contribution of a
license to Oerth Bio LLC (the Joint Venture).
Loss from Equity Method Investment: Loss from
equity method investment for the quarter ended September 30,
2019 was $24.7 million. This 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 $30.8 million for
the quarter ended September 30, 2020, as compared with $17.7
million for the quarter ended September 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-110ARV-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-471ARV-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 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 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 StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements regarding the development
and regulatory status of our product candidates ARV-110, ARV-471,
ARV-766, and other candidates in our pipeline, the conduct of and
plans for our ongoing Phase 1/2 clinical trials for ARV-110 and
ARV-471, our planned Phase 1b combination trial for ARV-471, our
planned Phase 1b combination trials for ARV-110, our planned IND
filing for ARV-766, the plans for presentation of data from our
Phase 1/1b/2 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 and Phase 1b combination trials for ARV-110 or 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.
Contacts for Arvinas
InvestorsWill O’Connor, Stern Investor
Relations ir@arvinas.com
MediaKirsten Owens, Arvinas
Communicationskirsten.owens@arvinas.com
Arvinas,
Inc. |
Consolidated
Statement of Operations (Unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue |
$ |
7,596,776 |
|
|
$ |
30,050,227 |
|
|
$ |
19,584,085 |
|
|
$ |
38,083,205 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
30,012,918 |
|
|
|
16,588,050 |
|
|
|
75,155,694 |
|
|
|
46,779,047 |
|
General and administrative |
|
9,331,925 |
|
|
|
7,957,364 |
|
|
|
26,072,404 |
|
|
|
20,038,772 |
|
Total
operating expenses |
|
39,344,843 |
|
|
|
24,545,414 |
|
|
|
101,228,098 |
|
|
|
66,817,819 |
|
Income
(loss) from operations |
|
(31,748,067 |
) |
|
|
5,504,813 |
|
|
|
(81,644,013 |
) |
|
|
(28,734,614 |
) |
Other income
(expenses) |
|
|
|
|
|
|
|
Other income, net |
|
144,215 |
|
|
|
405,302 |
|
|
|
841,967 |
|
|
|
840,153 |
|
Interest income |
|
800,236 |
|
|
|
1,112,415 |
|
|
|
3,065,220 |
|
|
|
3,394,269 |
|
Interest expense |
|
(16,250 |
) |
|
|
(22,903 |
) |
|
|
(48,750 |
) |
|
|
(69,319 |
) |
Total other
income |
|
928,201 |
|
|
|
1,494,814 |
|
|
|
3,858,437 |
|
|
|
4,165,103 |
|
Loss from
equity method investment |
|
— |
|
|
|
(24,675,000 |
) |
|
|
— |
|
|
|
(24,675,000 |
) |
Net
loss |
$ |
(30,819,866 |
) |
|
$ |
(17,675,373 |
) |
|
$ |
(77,785,576 |
) |
|
$ |
(49,244,511 |
) |
Net loss per
common share, basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.54 |
) |
|
$ |
(2.01 |
) |
|
$ |
(1.54 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
39,058,294 |
|
|
|
32,740,486 |
|
|
|
38,784,569 |
|
|
|
31,876,074 |
|
Arvinas,
Inc. |
Consolidated Balance
Sheet (Unaudited) |
|
|
|
|
|
September 30,2020 |
|
December 31,2019 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
88,988,921 |
|
|
$ |
9,211,057 |
|
Marketable securities |
|
159,574,963 |
|
|
|
271,661,456 |
|
Account receivable |
|
2,444,450 |
|
|
|
— |
|
Other receivables |
|
3,511,633 |
|
|
|
6,280,828 |
|
Prepaid expenses and other current assets |
|
3,459,862 |
|
|
|
3,727,294 |
|
Total
current assets |
|
257,979,829 |
|
|
|
290,880,635 |
|
Property,
equipment and leasehold improvements, net |
|
11,712,403 |
|
|
|
8,455,411 |
|
Operating
lease right of use assets |
|
2,226,422 |
|
|
|
2,278,623 |
|
Other
assets |
|
28,777 |
|
|
|
26,757 |
|
Total
assets |
$ |
271,947,431 |
|
|
$ |
301,641,426 |
|
Liabilities and stockholders’ equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
5,088,034 |
|
|
$ |
4,556,827 |
|
Accrued expenses |
|
12,143,734 |
|
|
|
7,602,904 |
|
Deferred revenue |
|
21,358,989 |
|
|
|
19,979,525 |
|
Current portion of operating lease liability |
|
939,761 |
|
|
|
673,896 |
|
Total
current liabilities |
|
39,530,518 |
|
|
|
32,813,152 |
|
Deferred
revenue |
|
23,945,470 |
|
|
|
38,427,882 |
|
Long term
debt |
|
2,000,000 |
|
|
|
2,000,000 |
|
Operating
lease liability |
|
1,351,476 |
|
|
|
1,714,111 |
|
Total
liabilities |
|
66,827,464 |
|
|
|
74,955,145 |
|
Commitments and Contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock, $0.001 par value; 40,096,001 and 38,461,353
shares issued and outstanding as of September 30, 2020 and December
31, 2019, respectively |
|
40,096 |
|
|
|
38,461 |
|
Accumulated deficit |
|
(450,342,422 |
) |
|
|
(372,556,846 |
) |
Additional paid-in capital |
|
654,342,486 |
|
|
|
599,097,090 |
|
Accumulated
other comprehensive income |
|
1,079,807 |
|
|
|
107,576 |
|
Total
stockholders’ equity |
|
205,119,967 |
|
|
|
226,686,281 |
|
Total
liabilities and stockholders’ equity |
$ |
271,947,431 |
|
|
$ |
301,641,426 |
|
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