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, 2023 and provided a corporate update.
“We continued making strong progress in the third quarter of
2023 as we executed across our entire portfolio of PROTAC® protein
degraders,” said John Houston, Ph.D., chairperson, chief executive
officer, and president at Arvinas. “We remain focused on developing
best-in-class medicines and are very pleased with the progress of
our ER and AR degraders, both of which have the potential to make
meaningful differences for patients. In the second half of next
year, we anticipate completion of our first Phase 3 trial with our
novel PROTAC ER degrader, vepdegestrant, in a second-line
metastatic breast cancer setting, which we are jointly developing
with Pfizer. Additionally, the profile of our PROTAC AR degrader,
ARV-766, gives us the confidence to initiate a Phase 3 trial in
metastatic castration resistant prostate cancer as soon as
possible. We are also preparing to move two new compounds – our
LRRK2 and BCL6 PROTAC protein degraders – into the clinic in 2024,
with two more PROTAC protein degraders in IND-enabling studies by
the end of 2023. We have a lot of milestones to deliver on in 2024
and I look forward to Arvinas’ continued success, with the
ultimate, and most important goal of improving the lives of
patients with serious diseases.”
Recent Developments and Third Quarter Business
Highlights
Androgen Receptor Franchise
- Presented data from the Phase 1/2 clinical trial with
bavdegalutamide at the European Society for Medical Oncology
Congress (ESMO) showing a median radiographic progression free
survival (rPFS) of 11.1 months in patients with AR 878/875 tumor
mutations, demonstrating the strong potential for a PROTAC® AR
degrader in prostate cancer.
- Manageable tolerability profile with no
grade >4 treatment-related adverse events (TRAEs).
- Prioritized the initiation of a Phase 3
trial with ARV-766 in mCRPC instead of the previously planned Phase
3 trial for bavdegalutamide.
- New interim data from Phase 1/2 trial
with ARV-766 showed a broader efficacy profile and superior
tolerability versus bavdegalutamide in the clinical setting, with a
potentially differentiated profile against other AR directed
therapies.
- Completed enrollment in the bavdegalutamide Phase 1b
combination trial with abiraterone.
Vepdegestrant (ARV-471)
- Presented updated dose-escalation data from the Phase 1/2 trial
with vepdegestrant at ESMO showing continued strong anti-tumor
activity and highly differentiated tolerability.
- Continued enrollment in 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 (ClinicalTrials.gov
Identifier: NCT05909397).
- 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 trial evaluating vepdegestrant with targeted therapies
[ClinicalTrials.gov Identifiers: NCT05548127 and
NCT05573555]).
- Continued enrollment in the
TACTIVE-E trial of vepdegestrant in combination with everolimus
(ClinicalTrials.gov Identifier: NCT05501769), and the TACTIVE-N
trial of vepdegestrant as a monotherapy in the neoadjuvant setting
(ClinicalTrials.gov Identifier: NCT05549505).
- Received Study May Proceed letter
from the U.S. FDA for the Phase 1b/2 clinical trial evaluating
vepdegestrant in combination with Pfizer's CDK4 inhibitor
(PF-07220060).
- Awarded Innovation Passport
Designation for vepdegestrant by the U.K. Innovative Licensing and
Access Pathway Steering Group.
Anticipated Upcoming Milestones and
Expectations
Vepdegestrant (ARV-471)As part of Arvinas’
global collaboration with Pfizer, the companies plan to:
- Present updated data for vepdegestrant at the San Antonio
Breast Cancer Symposium, including new data from the Phase 1b trial
assessing vepdegestrant in combination with palbociclib (December
2023).
- Continue enrollment in the study lead-in for the VERITAC-3
Phase 3 trial of vepdegestrant and palbociclib as a first-line
treatment in patients with ER+/HER2- locally advanced or metastatic
breast cancer.
- Initiate a Phase 1b/2 trial with vepdegestrant plus Pfizer’s
CDK4 (cyclin dependent kinase) inhibitor (4Q 2023).
- Continue enrollment of the Phase 1b combination umbrella trial
evaluating combination of vepdegestrant with abemaciclib and with
ribociclib (TACTIVE-U: ClinicalTrials.gov Identifiers: NCTC05548127
and NCTC05573555); initiate additional arm with Carrick
Therapeutics’ CDK7 inhibitor.
- Complete enrollment in the TACTIVE-N Phase 2 trial of
vepdegestrant as a monotherapy in the neoadjuvant setting
(ClinicalTrials.gov Identifier: NCT05549505) in patients with
ER+/HER2- localized breast cancer (2024).
- Complete enrollment of the VERITAC-2 Phase 3 monotherapy trial
(ClinicalTrials.gov Identifier: NCT05654623) in patients with
metastatic breast cancer (2H 2024).
Androgen Receptor (AR) Franchise
(ARV-766/bavdegalutamide (ARV-110))
- Continue enrollment of Phase 2 dose expansion study with
ARV-766, with progression free survival data anticipated in
2024.
- 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 (4Q 2023).
- Initiate discussions with regulatory authorities for a planned
Phase 3 trial with ARV-766 in mCRPC (2Q 2024).
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 Guidance
Based on its current operating plan, Arvinas believes its cash,
cash equivalents, restricted cash and marketable securities as of
September 30, 2023, is sufficient to fund planned operating
expenses and capital expenditure requirements into 2026.
Third Quarter Financial
Results
Cash, Cash Equivalents and Marketable Securities
Position: As of September 30, 2023, cash, cash
equivalents, restricted cash and marketable securities were
$1,004.0 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 $206.8 million for the
nine months ended September 30, 2023 was primarily related to
cash used in operations of $253.0 million (net of $2.5 million
received from two collaborators), leasehold improvements
of $2.8 million and loss on the sale of marketable securities
of $0.9 million, partially offset by net proceeds from the issuance
of common stock under our ATM offering of $36.0 million, unrealized
gains on marketable securities of $10.0 million and proceeds from
the exercise of stock options of $3.9 million.
Research and Development
Expenses: Research and development expenses were
$85.9 million for the quarter ended September 30, 2023,
as compared with $77.5 million for the quarter ended
September 30, 2022. The increase in research and development
expenses of $8.4 million for the quarter was primarily due to
increases our AR program of $5.2 million, which includes
ARV-766 and bavdegalutamide, and our ER program of
$6.2 million, which is net of the cost sharing
of vepdegestrant under the Vepdegestrant
(ARV-471) Collaboration Agreement, offset by a decrease in our
platform and exploratory programs of $3.0 million.
General and Administrative
Expenses: General and administrative expenses were
$22.6 million for the quarter ended September 30, 2023,
as compared with $20.0 million for the quarter ended
September 30, 2022. The increase of $2.6 million was
primarily due to increased investments in our commercial operations
of $1.0 million, an increase in personnel and infrastructure
related costs of $1.1 million, and an increase in professional
fees of $0.5 million.
Revenues: Revenues were $34.6 million for
the quarter ended September 30, 2023, as compared with
$33.2 million for the quarter ended September 30, 2022.
Revenue is related to the Vepdegestrant
(ARV-471) Collaboration Agreement, the collaboration and
license agreement with Bayer, the collaboration and license
agreement with Pfizer, the amended and restated option, license and
collaboration agreement with Genentech and revenue related to our
Oerth Bio joint venture which was initiated in July 2019. The
increase in revenues of $1.4 million was primarily due to an
increase in revenue from the Vepdegestrant (ARV-471) Collaboration
Agreement totaling $6.4 million, partially offset by a
decrease in revenue of $2.8 million of previously constrained
deferred revenue related to our Oerth Bio joint venture and a
decrease of $1.8 million related to the conclusion of the
performance period under the collaboration agreement with
Genentech.
Income Tax Expense: Income tax was zero
for the quarter ended September 30, 2023, as compared with an
income tax expense of $2.2 million for the quarter ended
September 30, 2022. Current year income tax expense was driven
by valuation allowance recorded against the full amount of its net
deferred tax assets. Prior year income 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 $0.1 million for the quarter
ended September 30, 2023, as compared with $2.9 million for
the quarter ended September 30, 2022, due to fully recognizing
the remaining Oerth Bio related constrained revenue, which limited
the amount of equity method losses recognized during the
quarter.
Net Loss: Net loss was $64.0 million
for the quarter ended September 30, 2023, as compared with
$66.2 million for the quarter ended September 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 and loss from
equity method investments, partly offset by increased research and
development expenses and general and administrative expenses.
About ARV-766 and bavdegalutamide
(ARV-110)ARV-766 and bavdegalutamide (ARV-110) are
investigational orally bioavailable PROTAC® protein degraders
designed to selectively target and degrade the androgen receptor
(AR). ARV-766 and bavdegalutamide 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 ER positive/human epidermal
growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
In preclinical studies, vepdegestrant demonstrated up to 97% ER
degradation in tumor cells, induced robust 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. Ongoing and planned clinical trials will
continue to monitor and evaluate the safety and anti-tumor activity
of vepdegestrant.
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: ARV-766 and bavdegalutamide 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, therapeutic benefits and opportunity of
vepdegestrant (ARV-471), ARV-766, bavdegalutamide (ARV-110), and
Arvinas’ other candidates in its pipeline; the development and
regulatory status of vepdegestrant (ARV-471), ARV-766, and
bavdegalutamide (ARV-110), such as statements with respect to the
initiation, continuation 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,
discussions with regulatory authorities and plans for registration;
Arvinas’ plans with respect to submission of investigational new
drug (IND)/clinical trial authorization (CTA) applications;
Arvinas’ plans to progress additional PROTAC protein degrader
programs into IND- or CTA-enabling studies; and the sufficiency of
Arvinas’ cash 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 its forward-looking statements, and you
should not place undue reliance on its 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 their respective obligations with
respect to the collaboration with Pfizer; whether Arvinas and
Pfizer will be able to successfully conduct and complete clinical
development for vepdegestrant; whether Arvinas will be able to
successfully conduct and complete development for its product
candidates, including whether Arvinas initiates and completes
clinical trials for its product candidates and receives results
from its clinical trials on its expected timelines or at all;
whether Arvinas obtains marketing approval for and commercializes
vepdegestrant ARV-766 and its other product candidates on Arvinas’
current timelines or at all; Arvinas’ ability to maintain and
protect its intellectual property portfolio; whether Arvinas’
cash and cash equivalent resources will be sufficient to fund
its 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, except per share amounts) |
September 30,2023 |
December 31,2022 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
113.7 |
|
$ |
81.3 |
|
Restricted cash |
|
5.5 |
|
|
5.5 |
|
Marketable securities |
|
884.8 |
|
|
1,124.0 |
|
Accounts receivable |
|
15.7 |
|
|
1.0 |
|
Other receivables |
|
4.9 |
|
|
7.0 |
|
Prepaid expenses and other current assets |
|
8.4 |
|
|
21.4 |
|
Total current assets |
|
1,033.0 |
|
|
1,240.2 |
|
Property,
equipment and leasehold improvements, net |
|
12.7 |
|
|
13.4 |
|
Operating
lease right of use assets |
|
3.0 |
|
|
4.4 |
|
Collaboration contract asset and other assets |
|
9.6 |
|
|
10.8 |
|
Total assets |
$ |
1,058.3 |
|
$ |
1,268.8 |
|
Liabilities and stockholders' equity |
|
|
Current liabilities: |
|
|
Accounts payable and accrued liabilities |
$ |
91.0 |
|
$ |
74.7 |
|
Deferred revenue |
|
224.2 |
|
|
218.6 |
|
Current portion of long term debt |
|
0.2 |
|
|
— |
|
Current portion of operating lease liability |
|
1.9 |
|
|
1.8 |
|
Total current liabilities |
|
317.3 |
|
|
295.1 |
|
Deferred
revenue |
|
281.9 |
|
|
405.1 |
|
Long term
debt |
|
0.8 |
|
|
1.0 |
|
Operating
lease liability |
|
1.1 |
|
|
2.7 |
|
Total liabilities |
|
601.1 |
|
|
703.9 |
|
Stockholders’ equity: |
|
|
Common stock, $0.001 par value; 55.0 and 53.2 shares issued and
outstanding as of September 30, 2023 and December 31,
2022, respectively |
|
0.1 |
|
|
0.1 |
|
Accumulated deficit |
|
(1,177.9 |
) |
|
(965.4 |
) |
Additional paid-in capital |
|
1,644.2 |
|
|
1,549.4 |
|
Accumulated other comprehensive loss |
|
(9.2 |
) |
|
(19.2 |
) |
Total stockholders’ equity |
|
457.2 |
|
|
564.9 |
|
Total liabilities and stockholders’ equity |
$ |
1,058.3 |
|
$ |
1,268.8 |
|
|
|
|
Arvinas,
Inc. |
Condensed
Consolidated Statements of Operations (Unaudited) |
|
|
|
|
|
|
Three Months EndedSeptember 30, |
Nine Months EndedSeptember 30, |
(dollars and shares in millions, except per share amounts) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
$ |
34.6 |
|
$ |
33.2 |
|
$ |
121.6 |
|
$ |
93.6 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
85.9 |
|
|
77.5 |
|
|
284.5 |
|
|
216.7 |
|
General and administrative |
|
22.6 |
|
|
20.0 |
|
|
73.3 |
|
|
64.5 |
|
Total operating expenses |
|
108.5 |
|
|
97.5 |
|
|
357.8 |
|
|
281.2 |
|
Loss
from operations |
|
(73.9 |
) |
|
(64.3 |
) |
|
(236.2 |
) |
|
(187.6 |
) |
Interest and
other income |
|
10.0 |
|
|
3.2 |
|
|
25.5 |
|
|
5.9 |
|
Net
loss before income taxes and loss from equity method
investment |
|
(63.9 |
) |
|
(61.1 |
) |
|
(210.7 |
) |
|
(181.7 |
) |
Income tax (expense) benefit |
|
— |
|
|
(2.2 |
) |
|
0.7 |
|
|
(10.1 |
) |
Loss from equity method investment |
|
(0.1 |
) |
|
(2.9 |
) |
|
(2.5 |
) |
|
(7.8 |
) |
Net
loss |
$ |
(64.0 |
) |
$ |
(66.2 |
) |
$ |
(212.5 |
) |
$ |
(199.6 |
) |
Net
loss per common share, basic and diluted |
$ |
(1.18 |
) |
$ |
(1.24 |
) |
$ |
(3.97 |
) |
$ |
(3.76 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
54.1 |
|
|
53.2 |
|
|
53.6 |
|
|
53.1 |
|
|
|
|
|
|
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