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, 2024, and provided a corporate update.
“We maintained strong momentum across our portfolio in the third
quarter and remain on track to report topline data from VERITAC-2,
our Phase 3 clinical trial in metastatic breast cancer, in the
fourth quarter of 2024 or the first quarter of 2025,” said John
Houston, Ph.D., Chairperson, Chief Executive Officer and President
at Arvinas. “In partnership with our colleagues at Pfizer, we are
excited by the possibility of changing the treatment paradigm for
ER+/HER2- breast cancer and look forward to sharing results from
VERITAC-2 in the coming months.”
“Our path to reaching our goal of becoming a multi-product,
commercial-stage organization with a robust pipeline across several
indications is clearly defined, and our novel PROTAC platform
technology has the potential to enable opportunities across
multiple therapeutic areas,” continued Dr. Houston. “We look
forward to completing the multiple ascending dose portion of our
Phase 1 clinical trial with ARV-102, our first PROTAC degrader with
the potential to treat neurodegenerative diseases, and sharing data
in 2025. We are also encouraged by the preclinical profile of
ARV-393, our BCL6 PROTAC degrader currently being evaluated in a
first-in-human Phase 1 clinical trial in patients with B-cell
lymphomas. We look forward to sharing more about these programs in
the coming months.”
3Q 2024 Business Highlights and Recent
Developments
Vepdegestrant
- Continued enrollment globally in multiple clinical studies of
vepdegestrant in ER+/HER2- metastatic breast cancer.
- VERITAC-2: Phase 3 monotherapy clinical trial in patients with
metastatic breast cancer (ClinicalTrials.gov Identifier:
NCT05654623)
- TACTIVE-U: Phase 1b/2 combination umbrella trial evaluating
combinations of vepdegestrant with abemaciclib, ribociclib, or
samuraciclib (ClinicalTrials.gov Identifiers: NCT05548127,
NCT05573555, and NCT06125522).
- TACTIVE-K: Phase 1/2 clinical trial with vepdegestrant plus
Pfizer’s novel CDK4 inhibitor atirmociclib (ClinicalTrials.gov
Identifier: NCT06206837)
ARV-102: Oral PROTAC LRRK2 degrader
- In October, presented preclinical data at the 2024 Michael J.
Fox Foundation Parkinson’s Disease Conference further supporting
the potential of PROTAC-induced leucine-rich repeat kinase 2
(LRRK2) degradation as a potential treatment for patients with
neurodegenerative diseases. New findings presented included data
demonstrating:
- Orally delivered ARV-102 crosses the blood-brain barriers and
degrades LRRK2 in the cerebrospinal fluid (CSF) of non-human
primates (NHPs).
- Degradation of LRRK2 by ARV-102 induces changes in pathway
(lysosomal and inflammation) biomarkers in the CSF of NHPs, which
has not previously been demonstrated by kinase inhibitors of
LRRK2.
- In murine tauopathy models, oral
PROTAC LRRK2 degrader treatment led to ~50% pathologic tau
reduction.
- Initiated the multiple ascending dose portion of the ongoing
Phase 1 clinical trial in healthy volunteers.
ARV-393: Oral PROTAC BCL6 degrader
- Continued recruiting patients in the first-in-human Phase 1
clinical trial in patients with B-cell lymphomas.
Anticipated Upcoming Milestones and
Expectations
Vepdegestrant
As part of Arvinas global collaboration with Pfizer, the
companies plan to:
- Complete enrollment (4Q24) and
announce topline data (4Q24/1Q25) for the VERITAC-2 Phase 3
monotherapy clinical trial in patients with metastatic breast
cancer.
- Present initial safety and
pharmacokinetic data from the TACTIVE-U sub-study (NCT05548127) of
abemaciclib in combination with vepdegestrant at the San Antonio
Breast Cancer Symposium (SABCS) in December 2024.
- Present data from the Phase 1
healthy volunteer pharmacokinetic trial of vepdegestrant in
combination with midazolam to assess potential for drug-drug
interaction at SABCS in December 2024 (NCT06256510).
- Continue enrollment of the ongoing
Phase 1b/2 combination umbrella trial evaluating combinations of
vepdegestrant with abemaciclib, ribociclib, or samuraciclib
(TACTIVE-U; ClinicalTrials.gov Identifiers: NCT05548127,
NCT05573555, and NCT06125522).
- Evaluate data from the study lead-in
of the VERITAC-3 Phase 3 trial (NCT05909397) in patients with
ER+/HER2- locally advanced or metastatic breast cancer (2H24).
- Continue enrollment and evaluate
preliminary data from the ongoing clinical trial with vepdegestrant
plus Pfizer’s novel CDK4 inhibitor atirmociclib (TACTIVE-K).
- Start Phase 3 combination trials in
the first- and second-line settings (anticipated in 2025; pending
emerging data and regulatory feedback).
- First-line setting with
vepdegestrant plus atirmociclib or palbociclib.
- Second-line setting with
vepdegestrant plus palbociclib and/or another CDK4/6
inhibitor.
ARV-102: Oral PROTAC LRRK2 degrader
- Complete enrollment in the ongoing
multiple ascending dose portion of a Phase 1 trial evaluating
ARV-102 in healthy volunteers
- Present data from the Phase 1 trial
in 2025.
ARV-393: Oral PROTAC BCL6 degrader
- Continue recruiting patients in the
first-in-human Phase 1 clinical trial evaluating ARV-393 in
patients with B-cell lymphomas.
Novel PROTAC KRAS G12D degrader
- File an Investigational New Drug
(IND) application in 2025.
Financial GuidanceBased on its current
operating plan, Arvinas believes its cash, cash equivalents, and
marketable securities as of September 30, 2024, is sufficient to
fund planned operating expenses and capital expenditure
requirements into 2027.
Third Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities
Position: As of September 30, 2024, cash, cash equivalents
and marketable securities were $1,121.6 million as compared with
cash, cash equivalents, restricted cash and marketable securities
of $1,266.5 million as of December 31, 2023. The decrease in cash,
cash equivalents and marketable securities of $144.9 million for
the nine months ended September 30, 2024 was primarily related to
cash used in operations of $158.1 million (net of $150.0 million
received from the Novartis agreements), inclusive of a one-time
cash termination fee in the amount of $41.5 million related to the
termination of our laboratory and office space lease with 101
College Street LLC in August 2024 and the purchase of lab equipment
and leasehold improvements of $1.5 million, partially offset by
proceeds from the exercise of stock options of $7.7 million and
unrealized gains on marketable securities of $7.2 million.
Research and Development Expenses:
Research and development expenses were $86.9 million for the
quarter ended September 30, 2024, as compared with $85.9 million
for the quarter ended September 30, 2023. The increase in research
and development expenses of $1.0 million for the quarter was
primarily due to an increase in compensation and related personnel
expenses of $2.8 million, which are not allocated by program,
partially offset by a decrease in external expenses of $2.2
million. External expenses include program-specific expenses, which
decreased by $1.1 million, primarily driven by decreases in our
ARV-766 and ARV-110 programs of $3.8 million and $1.6 million,
respectively, partially offset by increases in our ARV-102 and
ARV-393 programs of $2.5 million and $1.4 million, respectively,
and our non-program specific expenses, which decreased by $1.1
million.
General and Administrative Expenses:
General and administrative expenses were $75.8 million for the
quarter ended September 30, 2024, as compared with $22.6 million
for the quarter ended September 30, 2023. The increase in general
and administrative expenses of $53.2 million for the quarter was
primarily due to a loss on the termination of our laboratory and
office space lease with 101 College Street LLC of $43.4 million as
well as increases in personnel and infrastructure related costs of
$5.0 million, professional fees of $3.4 million and in developing
our commercial operations of $1.2 million.
Revenue: Revenue was $102.4 million for
the quarter ended September 30, 2024 as compared with $34.6 million
for the quarter ended September 30, 2023. Revenue for the quarter
is related to the license agreement with Novartis, the
Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the
collaboration and license agreement with Bayer and the
collaboration and license agreement with Pfizer. The increase in
revenue of $67.8 million was primarily due to revenue from the
Novartis license agreement of $76.7 million, offset by a decrease
in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement
with Pfizer of $7.6 million related to timing differences in
clinical trials and program expenses and a decrease in revenue from
Bayer of $1.1 million related to the termination of the Bayer
Collaboration Agreement in August 2024.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast
today, October 30, 2024, at 8:00 a.m. ET to review
its third quarter 2024 financial results and discuss recent
corporate updates. Participants are invited to listen by going to
the Events and Presentation section under the Investors page on the
Arvinas website at www.arvinas.com. A replay of the webcast will be
available on the Arvinas website following the completion of the
event and will be archived for up to 30 days.
About VepdegestrantVepdegestrant 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 (ER+)/human
epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-)
breast cancer. Vepdegestrant is being developed as a potential
monotherapy and as part of combination therapy across multiple
treatment settings for ER+/HER2- metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with
Pfizer for the co-development and co-commercialization of
vepdegestrant; Arvinas and Pfizer will share worldwide development
costs, commercialization expenses, and profits.
The U.S. Food and Drug Administration (FDA) has granted
vepdegestrant Fast Track designation as a monotherapy in the
treatment of adults with ER+/HER2- locally advanced or metastatic
breast cancer previously treated with endocrine-based therapy.
About ArvinasArvinas (Nasdaq: ARVN) is a
clinical-stage biotechnology company dedicated to improving the
lives of patients suffering from debilitating and life-threatening
diseases. Through its PROTAC® (PROteolysis Targeting Chimera)
protein degrader platform, the Company is pioneering the
development of protein degradation therapies designed to harness
the body’s natural protein disposal system to selectively and
efficiently degrade and remove disease-causing proteins. Arvinas is
currently progressing multiple investigational drugs through
clinical development programs, including vepdegestrant, targeting
the estrogen receptor for patients with locally advanced or
metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for
relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting
LRRK2 for neurodegenerative disorders. Arvinas is headquartered in
New Haven, Connecticut. For more information about Arvinas, visit
www.arvinas.com and connect
on LinkedIn and X.
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 expected timing in connection with the completion of enrollment
and reporting of topline data from the VERITAC-2 clinical trial;
the potential to change the treatment paradigm for ER+/HER2- breast
cancer; the goal of becoming a multi-product, commercial-stage
organization with a robust pipeline across several indications;
novel PROTAC platform technology having the potential to enable
opportunities across multiple therapeutic areas; plans to present
initial safety and pharmacokinetic data from the TACTIVE-U
sub-study of abemaciclib in combination with vepdegestrant at
SABCS; plans to present data from the Phase 1 healthy volunteer
pharmacokinetic trial of vepdegestrant in combination with
midazolam at SABCS; plans to continue enrollment in the TACTIVE-U
study and evaluate data from the study lead-in of the VERITAC-3
Phase 3 clinical trial; plans to continue enrollment and evaluate
preliminary data from the TACTIVE-K clinical trial; the expected
timing of initiation of Phase 3 vepdegestrant combination trials in
the first- and second-line settings, pending emerging data and
regulatory feedback; expected timing of filing an investigational
new drug application for a KRAS G12D degrader; plans to compete
enrollment in the multiple ascending dose portion of the ARV-102
Phase 1 clinical trial, the timing of the presentation of data from
such clinical trial, and the timing of sharing additional
information about the program; plans to continue recruiting
patients in the Phase 1 ARV-393 clinical trial and timing of
sharing additional information about the program; and statements
regarding Arvinas’ cash, cash equivalents and marketable
securities. All statements, other than statements of historical
fact, 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,” “goal,”
“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’s
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; whether Arvinas will be able to successfully conduct
and complete development for its other product candidates,
including whether Arvinas initiates and completes clinical trials
for its product candidates and receives results from its clinical
trials and preclinical studies on its expected timelines or at all;
whether Arvinas and Pfizer, as appropriate, will be able to obtain
marketing approval for and commercialize vepdegestrant 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 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, 2023 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, 2024 |
December 31,2023 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
85.2 |
|
$ |
311.7 |
|
|
Restricted cash |
|
— |
|
|
5.5 |
|
|
Marketable securities |
|
1,036.4 |
|
|
949.3 |
|
|
Accounts receivable |
|
7.3 |
|
|
— |
|
|
Other receivables |
|
7.5 |
|
|
7.2 |
|
|
Prepaid expenses and other current assets |
|
13.1 |
|
|
6.5 |
|
|
Total current assets |
|
1,149.5 |
|
|
1,280.2 |
|
|
Property, equipment and leasehold improvements, net |
|
6.8 |
|
|
11.5 |
|
|
Operating lease right of use assets |
|
1.0 |
|
|
2.5 |
|
|
Collaboration contract asset and other assets |
|
9.8 |
|
|
10.4 |
|
|
Total assets |
$ |
1,167.1 |
|
$ |
1,304.6 |
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
75.9 |
|
$ |
92.2 |
|
|
Deferred revenue |
|
199.2 |
|
|
163.0 |
|
|
Current portion of operating lease liabilities |
|
0.8 |
|
|
1.9 |
|
|
Total current liabilities |
|
275.9 |
|
|
257.1 |
|
|
Deferred revenue |
|
304.5 |
|
|
386.2 |
|
|
Long-term debt |
|
0.6 |
|
|
0.8 |
|
|
Operating lease liabilities |
|
0.1 |
|
|
0.5 |
|
|
Total liabilities |
|
581.1 |
|
|
644.6 |
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, zero shares issued and
outstanding as of September 30, 2024 and December 31,
2023, respectively |
|
— |
|
|
— |
|
|
Common stock, $0.001 par value; 68.7 and 68.0 shares issued and
outstanding as of September 30, 2024 and December 31,
2023, respectively |
|
0.1 |
|
|
0.1 |
|
|
Accumulated deficit |
|
(1,486.5 |
) |
|
(1,332.7 |
) |
|
Additional paid-in capital |
|
2,068.3 |
|
|
1,995.7 |
|
|
Accumulated other comprehensive income (loss) |
|
4.1 |
|
|
(3.1 |
) |
|
Total stockholders’ equity |
|
586.0 |
|
|
660.0 |
|
|
Total liabilities and stockholders’ equity |
$ |
1,167.1 |
|
$ |
1,304.6 |
|
| |
|
|
|
Arvinas, Inc. |
|
Condensed Consolidated Statements of Operations (Unaudited) |
| |
|
|
|
|
| |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|
(dollars and shares in millions, except per share amounts) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Revenue |
$ |
102.4 |
|
$ |
34.6 |
|
$ |
204.2 |
|
$ |
121.6 |
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
86.9 |
|
|
85.9 |
|
|
264.9 |
|
|
284.5 |
|
|
General and administrative |
|
75.8 |
|
|
22.6 |
|
|
131.3 |
|
|
73.3 |
|
|
Total operating expenses |
|
162.7 |
|
|
108.5 |
|
|
396.2 |
|
|
357.8 |
|
|
Loss from operations |
|
(60.3 |
) |
|
(73.9 |
) |
|
(192.0 |
) |
|
(236.2 |
) |
|
Interest and other income, net |
|
11.7 |
|
|
10.0 |
|
|
39.2 |
|
|
25.5 |
|
|
Net loss before income taxes and loss from equity method
investment |
|
(48.6 |
) |
|
(63.9 |
) |
|
(152.8 |
) |
|
(210.7 |
) |
|
Income tax (expense) benefit |
|
(0.6 |
) |
|
— |
|
|
(1.0 |
) |
|
0.7 |
|
|
Loss from equity method investment |
|
— |
|
|
(0.1 |
) |
|
— |
|
|
(2.5 |
) |
|
Net loss |
$ |
(49.2 |
) |
$ |
(64.0 |
) |
$ |
(153.8 |
) |
$ |
(212.5 |
) |
|
Net loss per common share, basic and diluted |
$ |
(0.68 |
) |
$ |
(1.18 |
) |
$ |
(2.14 |
) |
$ |
(3.97 |
) |
|
Weighted average common shares outstanding, basic and
diluted |
|
72.1 |
|
|
54.1 |
|
|
71.9 |
|
|
53.6 |
|
| |
|
|
|
|
Arvinas (NASDAQ:ARVN)
Graphique Historique de l'Action
De Oct 2024 à Nov 2024
Arvinas (NASDAQ:ARVN)
Graphique Historique de l'Action
De Nov 2023 à Nov 2024
