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 second
quarter ended June 30, 2023 and provided a corporate update.
“We continue to make meaningful advances across our entire
portfolio and have a data and milestone rich balance to the year,”
said John Houston, Ph.D., president and chief executive officer at
Arvinas. “In addition to sharing promising interim data from our
ongoing Phase 1/2 trial with ARV-766, and together with Pfizer, we
initiated enrollment for the study lead-in for the first-line Phase
3 trial with vepdegestrant in combination with palbociclib in
metastatic breast cancer. We now have two ongoing Phase 3 trials
with vepdegestrant with the potential for our first Phase 3 data
read-out in the second half of 2024. We are also on track to
initiate a Phase 3 trial with bavdegalutamide in the second half of
the year. These accomplishments are particularly meaningful as we
celebrate our 10-year anniversary this year and reflect our
commitment to bringing an entirely new class of transformative
medicines to patients.”
Recent Developments and Second Quarter Business
Highlights
- Initiated the study lead-in of the VERITAC-3 Phase 3 trial of
vepdegestrant plus palbociclib as a first-line treatment in
patients with ER+/HER2- locally advanced or metastatic breast
cancer.
- Shared data from the Phase 1/2 dose escalation and expansion
trial showing that ARV-766 was well-tolerated and demonstrated
promising activity in a heavily pre-treated, post-NHA, all-comers
patient population:
- 42% of patients with AR ligand binding domain (LBD) mutations
achieved PSA50.
- In all patients with L702H mutations, 3 of 5 achieved PSA50; in
patients with co-occurring T878/H875/L702 mutations, 3 of 3
achieved PSA50.
- RECIST (Response Evaluation Criteria in Solid Tumors) partial
responses were observed.
- Of four RECIST-evaluable patients with AR LBD mutations, one
achieved a confirmed partial response, and one achieved an
unconfirmed partial response.
- ARV-766 was well tolerated and the majority of
treatment-related adverse events (TRAEs) have been Grade 1 or 2,
with no Grade ≥4 TRAEs and no dose limiting toxicities.
- Low rates of discontinuation (1 of 47) and dose reductions (2
of 47) were observed.
- Evaluated and announced preliminary data from Part C of the
ongoing Phase 1b/2 ARV-471-mBC-101 study (ClinicalTrials.gov
Identifier: NCT04072952).
- Continued enrollment in the VERITAC-2 Phase 3 2L+ clinical
trial of vepdegestrant as a monotherapy for the treatment of
patients with ER+/HER2- metastatic breast cancer
(ClinicalTrials.gov Identifier: NCT05654623).
- Continued enrollment in the TACTIVE-U study (vepdegestrant in
combination with abemaciclib or ribociclib, [ClinicalTrials.gov
Identifiers: NCT05548127 and NCT05573555]) and, with Pfizer,
entered a collaboration and supply agreement with Carrick
Therapeutics to evaluate samuraciclib in combination with
vepdegestrant in the TACTIVE-U study.
- Continued enrollment in the TACTIVE-E study (vepdegestrant in
combination with everolimus; ClinicalTrials.gov Identifier:
NCT05501769), and the TACTIVE-N study (vepdegestrant as a
monotherapy in the neoadjuvant setting; ClinicalTrials.gov
Identifier: NCT05549505).
- Announced the inclusion of vepdegestrant in the I-SPY-2
(Investigation of Serial studies to Predict Your Therapeutic
Response with Imaging And moLecular analysis 2) trial sponsored by
Quantum Leap. The I-SPY-2 Endocrine Optimization Platform (EOP)
study (ClinicalTrials.gov Identifier: NCT01042379) includes a
vepdegestrant monotherapy arm and a vepdegestrant plus letrozole
arm.
- Awarded Innovation Passport Designation for vepdegestrant by
the U.K. Innovative Licensing and Access Pathway Steering
Group.
- Announced that John Houston, Ph.D., was named Chairperson
replacing Timothy Shannon, M.D., who stepped down from the role.
Additionally, Sunil Agarwal, M.D., was appointed to join the
company’s Board of Directors and Briggs Morrison, M.D., was
appointed Lead Independent Director of the Board.
Anticipated Upcoming Milestones and
Expectations
Vepdegestrant (ARV-471)As part of Arvinas’
global collaboration with Pfizer, the companies plan to:
- Present additional data from the Phase 1b combination trial
with palbociclib (ClinicalTrials.gov Identifier: NCT04072952) at a
medical congress (2H 2023).
- Continue enrollment in the study lead-in (SLI) of the VERITAC-3
Phase 3 trial in first-line ER+/HER2- locally advanced or
metastatic breast cancer. The SLI will identify the palbociclib
dose (75 or 100 mg) to combine with vepdegestrant in the randomized
portion of the study.
- Initiate Phase 1b/2 trial with vepdegestrant plus Pfizer’s CDK4
(cyclin dependent kinase) inhibitor (2H 2023).
- Initiate an additional arm of the Phase 1b/2 combination
umbrella trial (TACTIVE-U: ClinicalTrials.gov Identifiers:
NCT05548127 and NCT05573555) with Carrick Therapeutics’ CDK7
inhibitor (2H 2023).
- Complete enrollment in VERITAC-2 Phase 3 monotherapy trial
(ClinicalTrials.gov Identifier: NCT05654623) in patients with
metastatic breast cancer (2H 2024).
Androgen Receptor (AR) Franchise
(Bavdegalutamide/ARV-110, ARV-766)
- Present updated data, including radiographic progression free
survival, from the ongoing Phase 1/2 trial with bavdegalutamide at
the European Society for Medical Oncology congress in Madrid
(October 2023).
- Initiate a global Phase 3 trial with bavdegalutamide in mCRPC
(2H 2023).
- Complete enrollment in the Phase 1b combination study with
bavdegalutamide plus abiraterone (2H 2023).
- Initiate a Phase 1b/2 dose escalation trial with ARV-766 in
combination with abiraterone in patients who have not previously
received novel hormonal agents (2H 2023).
- Complete enrollment in the Phase 1b combination study with
bavdegalutamide plus abiraterone (2H 2023).
Pipeline:
- Submit two investigational new drug (IND)/clinical trial
authorization (CTA) applications for the Company’s BCL6 (oncology)
and LRRK2 (neuroscience) PROTAC protein degraders by year-end
2023.
- Progress at least two additional PROTAC protein degrader
programs into IND- or CTA-enabling studies by year-end 2023.
Financial GuidanceBased on its current
operating plan, Arvinas believes its cash, cash equivalents,
restricted cash and marketable securities as of June 30, 2023, is
sufficient to fund planned operating expenses and capital
expenditure requirements into 2026.
Second Quarter Financial Results
Cash, Cash Equivalents and Marketable Securities
Position: As of June 30, 2023, cash, cash equivalents,
restricted cash and marketable securities were $1,044.3 million as
compared with $1,210.8 million as of December 31, 2022. The
decrease in cash, cash equivalents, restricted cash and marketable
securities of $166.5 million for the six months ended June 30, 2023
was primarily related to cash used in operations of $172.9 million
(net of $2.5 million received from two collaborators), leasehold
improvements of $1.7 million and loss on the sale of marketable
securities of $0.9 million, partially offset by unrealized gains on
marketable securities of $7.0 million and proceeds from the
exercise of stock options of $2.0 million.
Research and Development Expenses: Research and
development expenses were $103.4 million for the quarter ended June
30, 2023, as compared with $75.3 million for the quarter ended June
30, 2022. The increase in research and development expenses of
$28.1 million for the quarter was primarily due to increasing
investment in our platform and exploratory programs of $5.4
million, as well as an increases our AR program of $7.4 million,
which includes bavdegalutamide and ARV-766, and our ER program of
$15.3 million, which is net of the cost sharing of vepdegestrant
(ARV-471) under the global Pfizer collaboration agreement to
develop and commercialize vepdegestrant that was initiated in July
2021 (Vepdegestrant (ARV-471) Collaboration Agreement).
General and Administrative Expenses: General
and administrative expenses were $25.7 million for the quarter
ended June 30, 2023, as compared with $24.3 million for the quarter
ended June 30, 2022. The increase of $1.4 million was primarily due
to an increase in professional fees of $2.0 million and increased
investments in our commercial operations of $0.9 million, offset in
part by reduced personnel and infrastructure related costs of $1.1
million and reduced insurance costs of $0.3 million.
Revenues: Revenues were $54.5 million for the
quarter ended June 30, 2023 as compared with $33.8 million for the
quarter ended June 30, 2022. Revenue is related to the
Vepdegestrant (ARV-471) Collaboration Agreement, 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, the amended and
restated option, license and collaboration agreement with Genentech
that was initiated in November 2017 and revenue related to our
Oerth Bio joint venture which was initiated in July 2019. The
increase in revenues of $20.7 million was primarily due to an
increase in revenue from the Vepdegestrant (ARV-471) Collaboration
Agreement totaling $24.2 million, partially offset by a net
decrease in revenue of $1.8 million as the performance period under
the collaboration agreement with Genentech has concluded and a
decrease of $1.2 million of previously constrained deferred revenue
related to our Oerth Bio joint venture.
Income Tax Expense: Income tax benefit was $0.3
million for the quarter ended June 30, 2023, as compared with an
income tax expense of $3.4 million for the quarter ended June 30,
2022. Current year tax benefit was driven by expected benefits from
state net operating loss carryback claims. Prior year tax expense
was driven by revenue recognized in 2022 for tax purposes from the
Vepdegestrant (ARV-471) Collaboration Agreement.
Loss from Equity Method Investment: Loss from
equity method investment was $1.3 million for the quarter ended
June 30, 2023, as compared with $2.5 million for the quarter ended
June 30, 2022 due to decreased operating losses incurred by Oerth
Bio.
Net Loss: Net loss was $66.6 million for the
quarter ended June 30, 2023, as compared with $70.0 million for the
quarter ended June 30, 2022. The decrease in net loss for the
quarter was primarily due to increased revenue and interest income
from our marketable securities, as well as decreased income tax
expense, partly offset by increased research and development
expenses and general and administrative expenses.
About bavdegalutamide (ARV-110) and
ARV-766Bavdegalutamide (ARV-110) and ARV-766 are
investigational orally bioavailable PROTAC® protein degraders
designed to selectively target and degrade the androgen receptor
(AR). Bavdegalutamide and ARV-766 are being developed as potential
treatments for men with prostate cancer. Preclinically, both
investigational agents have demonstrated activity in models of wild
type tumors in addition to tumors with AR mutation or
amplification, both common mechanisms of resistance to currently
available AR-targeted therapies.
About vepdegestrant (ARV-471)Vepdegestrant is
an investigational, orally bioavailable PROTAC® protein degrader
designed to specifically target and degrade the estrogen receptor
(ER) for the treatment of patients with early and locally advanced
or metastatic ER positive/human epidermal growth factor receptor 2
(HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in
the ongoing and planned clinical trials will continue to monitor
and evaluate patient safety and anti-tumor activity.
In preclinical studies, vepdegestrant demonstrated up to 97% ER
degradation in tumor cells, induced tumor shrinkage when dosed as a
single agent in multiple ER-driven xenograft models, and showed
increased 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. In July 2021, Arvinas announced a global
collaboration with Pfizer for the co-development and
co-commercialization of vepdegestrant; Arvinas and Pfizer will
equally share worldwide development costs, commercialization
expenses, and profits.
About ArvinasArvinas is a clinical-stage
biotechnology 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 investigational
clinical-stage programs: bavdegalutamide and ARV-766 for the
treatment of men with metastatic castration-resistant prostate
cancer; and vepdegestrant (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 within the meaning of The
Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties, including statements regarding
the potential advantages and therapeutic benefits of vepdegestrant
(ARV-471), bavdegalutamide (ARV-110), and ARV-766 and Arvinas’
other discovery programs, including LRRK2 and BCL6; the development
and regulatory status of Arvinas’ product candidates, including the
initiation of and timing of clinical trials, including the timing
to complete enrollment, as well as the presentation and/or
publication of data from clinical trials; Arvinas’ plans with
respect to submission of investigational new drug/clinical trial
authorization applications for BCL6 and LRRK2; Arvinas’ plans with
respect to at least two additional PROTAC protein degrader programs
into IND- or CTA-enabling studies; and the sufficiency of Arvinas’
cash, cash equivalents, restricted cash and marketable securities
resources to fund planned operating expenses and capital
expenditure requirements. All statements, other than statements of
historical facts, contained in this press release, including
statements regarding Arvinas’ strategy, future operations, future
financial position, future revenues, projected costs, 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.
Arvinas may not actually achieve the plans, intentions or
expectations disclosed in these forward-looking statements, and you
should not place undue reliance on such forward-looking statements.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements Arvinas makes as a result of various risks and
uncertainties, including but not limited to: Arvinas’ and Pfizer,
Inc.’s (“Pfizer”) performance of the respective obligations with
respect to Arvinas’ collaboration with Pfizer; whether Arvinas and
Pfizer will be able to successfully conduct and complete clinical
development for vepdegestrant (ARV-471); whether Arvinas will be
able to successfully conduct and complete development
for bavdegalutamide, ARV-766 and its other product
candidates, including whether Arvinas initiates and completes
clinical trials for its product candidates and receive results from
its clinical trials on its expected timelines or at all; whether
Arvinas and Pfizer, as appropriate, will be able to obtain
marketing approval for and commercialize vepdegestrant (ARV-471),
bavdegalutamide, ARV-766 and other product candidates on current
timelines or at all; Arvinas’ ability to protect its intellectual
property portfolio; whether Arvinas’ cash and cash equivalent
resources will be sufficient to fund our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements; and other important factors discussed in the “Risk
Factors” section of Arvinas’ Annual Report on Form 10-K for the
year ended December 31, 2022 and subsequent other reports on file
with the U.S. Securities and Exchange Commission. The
forward-looking statements contained in this press release reflect
Arvinas’ current views with respect to future events, and Arvinas
assumes 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 Arvinas’ views
as of any date subsequent to the date of this release.
ContactsInvestors:Jeff Boyle+1
(347) 247-5089Jeff.Boyle@arvinas.com
Media:Kirsten Owens+1 (203)
584-0307Kirsten.Owens@arvinas.com
Arvinas, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(dollars and shares in
millions) |
June 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
90.6 |
|
|
$ |
81.3 |
|
Restricted cash |
|
5.5 |
|
|
|
5.5 |
|
Marketable securities |
|
948.2 |
|
|
|
1,124.0 |
|
Accounts receivable |
|
0.1 |
|
|
|
1.0 |
|
Other receivables |
|
4.7 |
|
|
|
7.0 |
|
Prepaid expenses and other
current assets |
|
7.6 |
|
|
|
21.4 |
|
Total current
assets |
|
1,056.7 |
|
|
|
1,240.2 |
|
Property, equipment and
leasehold improvements, net |
|
13.2 |
|
|
|
13.4 |
|
Operating lease right of use
assets |
|
3.5 |
|
|
|
4.4 |
|
Collaboration contract asset
and other assets |
|
10.1 |
|
|
|
10.8 |
|
Total
assets |
$ |
1,083.5 |
|
|
$ |
1,268.8 |
|
Liabilities and
stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued
liabilities |
$ |
74.8 |
|
|
$ |
74.7 |
|
Deferred revenue |
|
230.1 |
|
|
|
218.6 |
|
Current portion of long term
debt |
|
0.1 |
|
|
|
— |
|
Current portion of operating
lease liability |
|
1.9 |
|
|
|
1.8 |
|
Total current
liabilities |
|
306.9 |
|
|
|
295.1 |
|
Deferred revenue |
|
310.5 |
|
|
|
405.1 |
|
Long term debt |
|
0.9 |
|
|
|
1.0 |
|
Operating lease liability |
|
1.6 |
|
|
|
2.7 |
|
Total
liabilities |
|
619.9 |
|
|
|
703.9 |
|
Stockholders’
equity: |
|
|
|
Common stock, $0.001 par
value; 53.4 and 53.2 shares issued and outstanding as of June 30,
2023 and December 31, 2022, respectively |
|
0.1 |
|
|
|
0.1 |
|
Accumulated deficit |
|
(1,113.9 |
) |
|
|
(965.4 |
) |
Additional paid-in
capital |
|
1,589.6 |
|
|
|
1,549.4 |
|
Accumulated other
comprehensive loss |
|
(12.2 |
) |
|
|
(19.2 |
) |
Total stockholders’
equity |
|
463.6 |
|
|
|
564.9 |
|
Total liabilities and
stockholders’ equity |
$ |
1,083.5 |
|
|
$ |
1,268.8 |
|
Arvinas, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
For the Three Months Ended June
30, |
|
For the Six Months Ended June
30, |
(dollars and shares in millions, except per share amounts) |
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
54.5 |
|
|
$ |
33.8 |
|
|
$ |
87.0 |
|
|
$ |
60.3 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
103.4 |
|
|
|
75.3 |
|
|
|
198.6 |
|
|
|
139.2 |
|
General and
administrative |
|
25.7 |
|
|
|
24.3 |
|
|
|
50.7 |
|
|
|
44.5 |
|
Total operating
expenses |
|
129.1 |
|
|
|
99.6 |
|
|
|
249.3 |
|
|
|
183.7 |
|
Loss from
operations |
|
(74.6 |
) |
|
|
(65.8 |
) |
|
|
(162.3 |
) |
|
|
(123.4 |
) |
Interest and other income |
|
9.0 |
|
|
|
1.7 |
|
|
|
15.5 |
|
|
|
2.7 |
|
Net loss before income
taxes and loss from equity method investment |
|
(65.6 |
) |
|
|
(64.1 |
) |
|
|
(146.8 |
) |
|
|
(120.7 |
) |
Income tax benefit
(expense) |
|
0.3 |
|
|
|
(3.4 |
) |
|
|
0.7 |
|
|
|
(7.9 |
) |
Loss from equity method
investment |
|
(1.3 |
) |
|
|
(2.5 |
) |
|
|
(2.4 |
) |
|
|
(4.8 |
) |
Net loss |
$ |
(66.6 |
) |
|
$ |
(70.0 |
) |
|
$ |
(148.5 |
) |
|
$ |
(133.4 |
) |
Net loss per common
share, basic and diluted |
$ |
(1.25 |
) |
|
$ |
(1.32 |
) |
|
$ |
(2.78 |
) |
|
$ |
(2.51 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
53.4 |
|
|
|
53.2 |
|
|
|
53.4 |
|
|
|
53.1 |
|
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