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 first quarter
ended March 31, 2021 and provided a corporate update.
“Last quarter we reinforced our leadership position in the
targeted protein degradation space by sharing the discovery and
chemical structures of ARV-110 and ARV-471 at the American
Association for Cancer Research (AACR) Annual Meeting, the first
such disclosure of our clinical-stage PROTAC degraders,” said John
Houston, Ph.D., President and Chief Executive Officer at Arvinas.
“We look forward to further demonstrating the potential of our
PROTAC platform to change the lives of patients with few or no
therapeutic options.”
Business Highlights and Recent Developments
- Presented preclinical data describing the discovery of Arvinas’
two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including
the first disclosures of their structures at AACR
Anticipated Milestones and Expectations
ARV-471
- Completion of the Phase 1 dose escalation (1H21)
- Presentation of completed Phase 1 dose escalation data
(2H21)
- Interim review of safety and dose finding data from the Phase
1b trial in combination with Ibrance® (palbociclib) (2H21)
- Initiation of a window of opportunity study in early 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)
- Presentation of interim data from the ARDENT Phase 2 dose
expansion at 420 mg (2H21)
- Initiation of combination trial(s) with standard(s)-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.
First Quarter Financial Results
Cash, Cash Equivalents and Marketable Securities
Position: As of March 31, 2021, cash, cash
equivalents and marketable securities were $651.3 million as
compared with $688.5 million as of December 31, 2020. The decrease
primarily related to cash used to fund operations of $43.9 million,
cash used to purchase fixed assets and leasehold improvements of
$1.0 million and unrealized losses of $0.8 million, partially
off-set by proceeds from two collaborators of $4.0 million and
proceeds from the exercise of stock options of $4.5 million.
Research and Development
Expenses: Research and development expenses were
$34.9 million for the quarter ended March 31, 2021 as compared with
$21.7 million for the quarter ended March 31, 2020. The increase in
research and development expenses for the quarter of $13.2 million
primarily related to Arvinas’ continued investment in its platform,
exploratory and lead optimization programs of $8.3 million, its AR
program of $1.5 million and estrogen receptor program (ER) of $3.4
million.
General and Administrative
Expenses: General and administrative expenses were
$12.3 million for the quarter ended March 31, 2021 as compared with
$7.9 million for the quarter ended March 31, 2020. The increase in
general and administrative expenses for the quarter of $4.4 million
related to an increase of $3.6 million in personnel and facility
related costs, including $1.8 million related to stock compensation
expense, and insurance, taxes and professional fees of $0.8
million.
Revenues: Revenues were $5.5 million for the
quarter ended March 31, 2021 as compared with $6.2 million for the
quarter ended March 31, 2020 and 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 decrease in collaboration
revenue of $0.7 million for the quarter was primarily related to a
collaborator adding new targets that extended the period of revenue
recognition for that collaboration agreement.
Net Loss: Net loss was $41.0 million for
the quarter ended March 31, 2021 as compared with $21.7 million for
the quarter ended March 31, 2020. The increase in net loss for the
quarter ended March 31, 2021 of $19.3 million 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 costs.
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 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, including the
timing 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 or conduct a Phase 1 clinical trial for 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
InvestorsWill O’Connor, Stern Investor
Relations ir@arvinas.com
MediaKirsten Owens, Arvinas
Communicationskirsten.owens@arvinas.com
Arvinas,
Inc. |
Consolidated
Statement of Operations (Unaudited) |
|
|
|
|
Three Months Ended March 31, |
|
|
2021 |
|
|
|
2020 |
|
Revenue |
$ |
5,539,365 |
|
|
$ |
6,239,628 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
34,866,882 |
|
|
|
21,726,686 |
|
General and administrative |
|
12,318,713 |
|
|
|
7,925,005 |
|
Total
operating expenses |
|
47,185,595 |
|
|
|
29,651,691 |
|
Loss from
operations |
|
(41,646,230 |
) |
|
|
(23,412,063 |
) |
Interest and other income |
|
681,939 |
|
|
|
1,672,892 |
|
Net
loss |
|
(40,964,291 |
) |
|
|
(21,739,171 |
) |
Net loss per
common share, basic and diluted |
|
(0.84 |
) |
|
|
(0.56 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
48,621,663 |
|
|
|
38,548,483 |
|
|
|
|
Arvinas,
Inc. |
Consolidated Balance
Sheet (Unaudited) |
|
|
|
|
|
March 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
346,068,406 |
|
|
$ |
588,373,232 |
|
Marketable securities |
|
305,203,086 |
|
|
|
100,157,618 |
|
Account receivable |
|
— |
|
|
|
1,000,000 |
|
Other receivables |
|
5,175,378 |
|
|
|
7,443,654 |
|
Prepaid expenses and other current assets |
|
8,209,888 |
|
|
|
6,113,122 |
|
Total
current assets |
|
664,656,758 |
|
|
|
703,087,626 |
|
Property,
equipment and leasehold improvements, net |
|
12,210,324 |
|
|
|
12,259,515 |
|
Operating
lease right of use assets |
|
4,876,584 |
|
|
|
1,992,669 |
|
Other
assets |
|
28,777 |
|
|
|
28,777 |
|
Total
assets |
$ |
681,772,443 |
|
|
$ |
717,368,587 |
|
Liabilities and stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
9,002,938 |
|
|
$ |
7,121,879 |
|
Accrued expenses |
|
8,001,201 |
|
|
|
18,859,840 |
|
Deferred revenue |
|
22,150,861 |
|
|
|
22,150,861 |
|
Current portion of operating lease liabilities |
|
1,216,914 |
|
|
|
952,840 |
|
Total
current liabilities |
|
40,371,914 |
|
|
|
49,085,420 |
|
Deferred
revenue |
|
20,400,518 |
|
|
|
22,938,233 |
|
Long term
debt, net of current portion |
|
2,000,000 |
|
|
|
2,000,000 |
|
Operating
lease liabilities |
|
3,701,991 |
|
|
|
1,087,422 |
|
Total
liabilities |
|
66,474,423 |
|
|
|
75,111,075 |
|
Commitments
and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock, $0.001 par value, 48,785,692 and 48,455,741 shares
issued and outstanding as of March 31, 2021 and December 31, 2020,
respectively |
|
48,786 |
|
|
|
48,455 |
|
Accumulated deficit |
|
(532,853,201 |
) |
|
|
(491,888,910 |
) |
Additional paid-in capital |
|
1,148,345,190 |
|
|
|
1,133,537,171 |
|
Accumulated other comprehensive income |
|
(242,755 |
) |
|
|
560,796 |
|
Total
stockholders' equity |
|
615,298,020 |
|
|
|
642,257,512 |
|
Total
liabilities and stockholders' equity |
$ |
681,772,443 |
|
|
$ |
717,368,587 |
|
|
|
|
|
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