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 first quarter
ended March 31, 2023 and provided a corporate update.
“We made substantial progress throughout the first quarter
across all areas of our early- and late-stage pipeline,” said John
Houston, Ph.D., president and chief executive officer at Arvinas.
“Preliminary data from the ongoing Phase 1b combination study of
vepdegestrant with palbociclib reinforce our confidence in the
potential of vepdegestrant as an important treatment option in
metastatic breast cancer. Together with Pfizer, we are on-track to
initiate the safety lead-in to identify the dose of palbociclib for
the planned Phase 3 trial with vepdegestrant and palbociclib. For
bavdegalutamide, we are also on track to initiate a phase 3 trial
in the second half of 2023, and we plan to share radiographic
progression free survival data from the Phase 1/2 trial in the
second half of 2023 as well. We look forward to progressing our
clinical programs and new clinical candidates in the coming
years.”
Recent Developments and 1Q Business
Highlights
- Evaluated preliminary data (November 2022 cutoff) from Part C
of the ongoing Phase 1b/2 ARV-471-mBC-101 study (ClinicalTrials.gov
Identifier: NCT04072952).
- Preliminary results from the Part C dose escalation (the Phase
1b combination of vepdegestrant + palbociclib 125 mg) demonstrate
an observed clinical benefit rate (CBR; rate of confirmed complete
response, confirmed partial response, or stable disease ≥24 weeks)
of 60.7% (95% CI, 40.6 – 78.5) across all dose cohorts (17 of 28
CBR-evaluable patients; patients are CBR-evaluable if they received
their first dose >24 weeks prior to the cut-off). Data are
expected to be presented at a medical conference in the second half
of 2023.
- 85.7% of the 28
CBR-evaluable patients had received CDK4/6 inhibitor therapy prior
to study entry.
- An increase in
palbociclib exposure was observed relative to historical
palbociclib pharmacokinetic data.
- A similar overall
safety profile was observed compared with that reported in previous
palbociclib and endocrine therapy combination studies, except for a
higher incidence of grade 3/4 neutropenia, which was managed by
monitoring and dose modification per the palbociclib label.
Patients were started on palbociclib 125 mg irrespective of dose
reduction during prior CDK4/6 inhibitor therapy.
- Gained alignment with the U.S. Food and Drug Administration on
an approach for the planned 1L Phase 3 trial (VERITAC-3) with
vepdegestrant (200 mg) in combination with palbociclib.
- The safety lead-in
is on-track to initiate in 2H 2023 and will start with a lead-in to
evaluate the best starting dose of palbociclib (100 mg or 75 mg) in
combination with vepdegestrant 200 mg once daily.
- The objective is to
select a dose of palbociclib (100 mg or 75 mg) that, when dosed
with vepdegestrant 200 mg, results in a similar exposure and safety
profile as palbociclib 125 mg in combination with aromatase
inhibitors.
- 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:
NCTC05548127 and NCTC05573555), 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 (Identifier:
NCT01042379) will include a vepdegestrant monotherapy arm and a
vepdegestrant plus letrozole arm.
- Presented
vepdegestrant pre-clinical data at American Association for Cancer
Research (AACR) annual meeting in April 2023 demonstrating:
- The potential
utility of vepdegestrant as an endocrine therapy backbone for
combination with other targeted agents in early and late-stage
ER+/HER2- breast cancer.
- The potential
mechanisms of acquired resistance to vepdegestrant that may be
associated with alterations within Receptor Tyrosine Kinase/MAPK
signaling pathways rather than ER signaling or E3 ligase
machinery.
- Presented new in
vivo and in vitro data at AACR - Targeting RAS Special Conference
demonstrating:
- Arvinas’ KRAS G12D
PROTAC degraders are potent, selective and led to tumor stasis in a
mouse xenograft model with intermittent dosing.
- Degradation of KRAS
G12D provides an advantage vs. inhibition in vitro and in
vivo.
- Presented new
ARV-766 preclinical data and compound structure at the AACR annual
meeting in April 2023.
- Presented new
preclinical data at the CHDI Foundation’s Annual Huntington’s
Disease Therapeutics Conference showing that Arvinas PROTAC
degraders potently and selectively degrade soluble mutant
huntingtin (mHTT) in multiple cellular readouts, including rodent
neurons, while sparing wild-type HTT.
- Appointed Kelly Page
as Senior Vice President, Global Head of Oncology Strategy and
Program Leadership.
- Announced that
Timothy Shannon, M.D., our current Chairperson and a member of our
board of directors since July 2013, will not be standing for
re-election at the Annual Meeting.
“Tim’s support, guidance and unwavering dedication has been
instrumental in our success since our founding 10 years ago,”
continued Dr. Houston. “We are grateful for his years of service on
the Board, and on behalf of the entire Company, we thank Tim for
his strategic insight, wisdom and integrity – all of which are
ingrained in our work as we make progress towards improving the
lives of patients with serious diseases.”
Anticipated Upcoming Milestones and
Expectations
Vepdegestrant (ARV-471)As part of Arvinas’
global collaboration with Pfizer, the companies plan to:
- Initiate the safety lead-in to identify the dose of palbociclib
for the planned Phase 3 trial with vepdegestrant + palbociclib as a
first-line treatment in patients with ER+/HER2- locally advanced or
metastatic breast cancer (2H 2023).
- Submit and present additional data from the Phase 1b
combination trial with palbociclib (ClinicalTrials.gov Identifier:
NCT04072952) at a medical congress (2H 2023).
- Initiate additional arms of the Phase 1b combination umbrella
trial (TACTIVE-U: ClinicalTrials.gov Identifiers: NCTC05548127 and
NCTC05573555) with other targeted therapies (2H 2023).
- Complete enrollment for 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)
- Share data from the Phase 1 dose escalation trial with ARV-766
in metastatic castration-resistant prostate cancer (mCRPC) (2Q
2023).
- Submit and present additional data, including radiographic
progression free survival, from the ongoing Phase 1/2 trial with
bavdegalutamide at a medical congress (2H 2023).
- Initiate a global Phase 3 trial with bavdegalutamide in mCRPC
for patients with AR T878/H875 tumor mutations (2H 2023).
- Complete enrollment in the Phase 1b combination study with
bavdegalutamide plus abiraterone (2H 2023).
- Initiate a Phase 1b or Phase 2 trial in patients who have not
previously received novel hormonal agents (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 March 31, 2023, is
sufficient to fund planned operating expenses and capital
expenditure requirements into 2026.
First Quarter Financial
Results
Cash, Cash Equivalents, Restricted Cash and Marketable
Securities Position: As of March 31, 2023, cash, cash
equivalents, restricted cash and marketable securities were
$1,129.0 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 $81.8 million for the three months
ended March 31, 2023 was primarily related to cash used in
operations of $87.9 million (net of $2.5 million received from two
collaborators), loss on the sale of marketable securities of $0.9
million and the purchase of lab equipment and leasehold
improvements of $1.1 million, partially offset by unrealized gains
on marketable securities of $6.6 million and proceeds from the
exercise of stock options of $1.5 million.
Research and Development Expenses: Research and
development expenses were $95.3 million for the quarter ended March
31, 2023, as compared with $64.0 million for the quarter ended
March 31, 2022. The increase in research and development expenses
of $31.3 million for the quarter was primarily due to an increase
in our continued investment in our platform and exploratory
programs of $18.3 million, as well as an increase in expenses
related to our AR program of $3.5 million, which includes
bavdegalutamide and ARV-766, and our ER program of $9.5 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
(ARV-471 Collaboration Agreement).
General and Administrative Expenses: General
and administrative expenses were $24.9 million for the quarter
ended March 31, 2023, as compared with $20.2 million for the
quarter ended March 31, 2022. The increase of $4.7 million was
primarily due to an increase in personnel costs of $2.3 million and
professional fees of $1.4 million.
Revenues: Revenues were $32.5 million for the
quarter ended March 31, 2023, as compared with $26.5 million for
the quarter ended March 31, 2022. Revenue is related to the 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 $6.0 million was primarily due to an increase in
revenue from the ARV-471 Collaboration Agreement totaling $15.9
million, partially offset by a net decrease in revenue totaling
$8.2 million due to extensions of the period of revenue recognition
under both the Pfizer and Bayer collaboration agreements 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 $0.4
million for the quarter ended March 31, 2023, as compared with an
income tax expense of $4.5 million for the quarter ended March 31,
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
ARV-471 Collaboration Agreement.
Loss from Equity Method Investment: Loss from
equity method investment was $1.1 million for the quarter ended
March 31, 2023, as compared with $2.3 million for the quarter ended
March 31, 2022 due to decreased operating losses incurred by Oerth
Bio.
Net Loss: Net loss was $81.9 million for the
quarter ended March 31, 2023, as compared with $63.4 million for
the quarter ended March 31, 2022. The increase in net loss for the
quarter was primarily due to increased research and development
expenses and general and administrative expenses, partially offset
by decreased income tax expense and increased revenue.
About bavdegalutamide (ARV-110)Bavdegalutamide
(ARV-110) is an investigational orally bioavailable PROTAC® protein
degrader designed to selectively target and degrade the androgen
receptor (AR). Bavdegalutamide is being developed as a potential
treatment for men with mCRPC.
Bavdegalutamide has demonstrated activity in preclinical models
of AR mutation or overexpression, 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 Statements This 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
bavdegalutamide (ARV-110), vepdegestrant (ARV-471), and ARV-766 and
our other discovery programs, the development and regulatory status
of our product candidates, such as statements with respect to the
potential of our lead product candidates bavdegalutamide,
vepdegestrant, ARV-766 and other candidates in our pipeline, and,
including the initiation of and timing of the timing of clinical
trials, including the timing to complete enrollment, as well as the
presentation and/or publication of data from those trials and plans
for registration for our product candidates, and
our discovery programs that may lead to our development
of additional product candidates, the potential utility of our
technology, our plans with respect to submission of investigational
new drug/clinical trial authorization applications, the potential
commercialization of any of our product candidates, and the
sufficiency of our cash resources. All statements, other than
statements of historical facts, contained in this press release,
including statements regarding our 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.
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: our and Pfizer, Inc.’s (“Pfizer”)
performance of our respective obligations with respect to our
collaboration with Pfizer; whether we and Pfizer will be able to
successfully conduct and complete clinical development for
vepdegestrant; whether we will be able to successfully conduct and
complete development for bavdegalutamide, ARV-766 and
our other product candidates, including whether we initiate
and complete clinical trials for our product candidates and receive
results from our clinical trials on our expected timelines or at
all; obtain marketing approval for and commercialize vepdegestrant,
bavdegalutamide, ARV-766 and our other product candidates on our
current timelines or at all; whether our 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 our Annual Report of Form 10-K for the year
ended December 31, 2021 and subsequent other 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.
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) |
March 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
130.2 |
|
|
$ |
81.3 |
|
Restricted cash |
|
5.5 |
|
|
|
5.5 |
|
Marketable securities |
|
993.3 |
|
|
|
1,124.0 |
|
Accounts receivable |
|
— |
|
|
|
1.0 |
|
Other receivables |
|
4.7 |
|
|
|
7.0 |
|
Prepaid expenses and other
current assets |
|
14.5 |
|
|
|
21.4 |
|
Total current
assets |
|
1,148.2 |
|
|
|
1,240.2 |
|
Property, equipment and
leasehold improvements, net |
|
13.4 |
|
|
|
13.4 |
|
Operating lease right of use
assets |
|
3.9 |
|
|
|
4.4 |
|
Collaboration contract asset
and other assets |
|
10.3 |
|
|
|
10.8 |
|
Total
assets |
$ |
1,175.8 |
|
|
$ |
1,268.8 |
|
Liabilities and
stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued
liabilities |
$ |
66.0 |
|
|
$ |
74.7 |
|
Deferred revenue |
|
214.9 |
|
|
|
218.6 |
|
Current portion of long term
debt |
|
0.1 |
|
|
|
— |
|
Current portion of operating
lease liability |
|
1.9 |
|
|
|
1.8 |
|
Total current
liabilities |
|
282.9 |
|
|
|
295.1 |
|
Deferred revenue |
|
378.9 |
|
|
|
405.1 |
|
Long term debt |
|
0.9 |
|
|
|
1.0 |
|
Operating lease liability |
|
2.1 |
|
|
|
2.7 |
|
Total
liabilities |
|
664.8 |
|
|
|
703.9 |
|
Stockholders’
equity: |
|
|
|
Common stock, $0.001 par
value; 53.4 and 53.2 shares issued and outstanding as of March 31,
2023 and December 31, 2022, respectively |
|
0.1 |
|
|
|
0.1 |
|
Accumulated deficit |
|
(1,047.3 |
) |
|
|
(965.4 |
) |
Additional paid-in
capital |
|
1,570.8 |
|
|
|
1,549.4 |
|
Accumulated other
comprehensive loss |
|
(12.6 |
) |
|
|
(19.2 |
) |
Total stockholders’
equity |
|
511.0 |
|
|
|
564.9 |
|
Total liabilities and
stockholders’ equity |
$ |
1,175.8 |
|
|
$ |
1,268.8 |
|
Arvinas, Inc.Condensed Consolidated Statements of
Operations (Unaudited) |
|
|
For the Three Months Ended March
31, |
(dollars and shares in
millions, except per share amounts) |
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
32.5 |
|
|
$ |
26.5 |
|
Operating
expenses: |
|
|
|
Research and development |
|
95.3 |
|
|
|
64.0 |
|
General and
administrative |
|
24.9 |
|
|
|
20.2 |
|
Total operating
expenses |
|
120.2 |
|
|
|
84.2 |
|
Loss from
operations |
|
(87.7 |
) |
|
|
(57.7 |
) |
Interest and other income |
|
6.5 |
|
|
|
1.1 |
|
Net loss before income
taxes and loss from equity method investment |
|
(81.2 |
) |
|
|
(56.6 |
) |
Income tax benefit
(expense) |
|
0.4 |
|
|
|
(4.5 |
) |
Loss from equity method
investment |
|
(1.1 |
) |
|
|
(2.3 |
) |
Net loss |
$ |
(81.9 |
) |
|
$ |
(63.4 |
) |
Net loss per common
share, basic and diluted |
$ |
(1.54 |
) |
|
$ |
(1.20 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
53.3 |
|
|
|
53.0 |
|
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