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 fourth
quarter and full year ended December 31, 2023, and provided a
corporate update.
“Our focused execution in 2023 enabled us to progress multiple
trials across our entire portfolio and we are well-positioned for a
catalyst rich year ahead, including completing our first Phase 3
trial,” said John Houston, Ph.D., president and chief executive
officer at Arvinas. “Our collaboration with Pfizer remains strong
and we are on track to report topline data from our first Phase 3
clinical trial with vepdegestrant, the only PROTAC® ER degrader in
clinical development for patients with ER+/HER2- breast cancer. If
successful, assuming regulatory approval, we have the opportunity
to address an area of high unmet need and offer patients a new oral
treatment option in the second-line metastatic breast cancer
setting. And with the recent Phase 1 initiation with our LRRK2
PROTAC® degrader – our first neuroscience program – we continue
making significant progress with our novel PROTAC® technology.”
Recent Developments and Fourth Quarter Business
Highlights
Vepdegestrant (ARV-471)
- Received U.S. Food and Drug Administration Fast Track
designation for the investigation of vepdegestrant for monotherapy
in the treatment of adults with estrogen receptor (ER)
positive/human growth epidermal growth factor 2 (HER2) negative
(ER+/HER2-) locally advanced or metastatic breast cancer previously
treated with endocrine-based therapy.
- Presented interim results (data cutoff: June 6, 2023) from the
Phase 1b vepdegestrant and palbociclib (IBRANCE®)
combination cohort at the 2023 San Antonio Breast Cancer Symposium
(SABCS), which demonstrated encouraging clinical activity in
heavily pre-treated patients with locally advanced or metastatic
ER+/HER2- breast cancer with a median of four lines of therapy
across disease settings.
- A clinical benefit rate (CBR, defined
as the rate of confirmed complete response, partial response, or
stable disease ≥ 24 weeks) of 63% (95% CI: 47.5–76.8), or 29/46
patients; at the recommended Phase 3 dose of 200 mg (n=21), the CBR
was 67% (95% CI: 43.0 – 85.4), or 14/21 patients.
- An objective response rate (ORR) in
evaluable patients with measurable disease at baseline (n=31) of
42% (95% CI: 24.5–60.9), or 13/31 patients; at the RP3D of 200 mg
(n=15), the ORR was 53% (95% CI: 26.6 – 78.7); the median duration
of response was 10.2 months.
- Median progression free survival (PFS)
of 11.1 months (95% CI: 8.2 – NE); 22 of 46 patients across all
doses had progression events by time of data cutoff.
- Median PFS of 11.1 and 11.0 months in
patients with ESR1 wild-type and ESR1 mutant tumors,
respectively.
- The safety profile of vepdegestrant
plus palbociclib was manageable. The primary toxicity was
neutropenia, which was managed with palbociclib dose modifications
(reductions and/or interruptions) per protocol. There was no
febrile neutropenia and 3 of 46 patients discontinued due to
neutropenia.
- Initiated Phase 1b/2 with vepdegestrant plus Pfizer’s novel
CDK4 inhibitor (PF-07220060) (TACTIVE-K: ClinicalTrials.gov
Identifier: NCT06206837).
- Initiated an additional arm of the Phase 1b/2 combination
umbrella trial with the CDK7 inhibitor samuraciclib (TACTIVE-U:
ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and
NCT06125522).
- Completed enrollment in the TACTIVE-N Phase 2 trial of
vepdegestrant as a monotherapy in the neoadjuvant setting in
patients with ER+/HER2- localized breast cancer (ClinicalTrials.gov
Identifier: NCT05549505).
- Completed enrollment in the TACTIVE-E Phase 1 trial of
vepdegestrant in combination with everolimus for the treatment of
advanced or metastatic ER+/HER2- breast cancer (ClinicalTrials.gov
Identifier: NCT05501769).
Androgen Receptor PROTAC® degraders
- Presented data from the Phase 1/2 clinical trial with
bavdegalutamide (ARV-110) at the European Society for Medical
Oncology (ESMO) Congress 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).
- Selected our second generation PROTAC®
AR degrader, ARV-766, as the lead program in prostate cancer and
prioritized the initiation of a Phase 3 trial with ARV-766 in
metastatic castrate resistant prostate cancer (mCRPC).
- 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.
Pipeline
- Received authorization from the European Medicines Agency to
initiate clinical trials with the Company’s new PROTAC® degrader,
ARV-102, designed to target the LRRK2 protein.
- Initiated first-in-human Phase 1
clinical trial in healthy volunteers with LRRK2 targeting PROTAC®
ARV-102.
- Received clearance from the U.S.
Food and Drug Administration to initiate clinical trials with the
Company’s PROTAC® degrader, ARV-393, designed to target the BCL6
protein.
Corporate
- Completed oversubscribed $350 million private placement co-led
by EcoR1 Capital and RTW Investments LP, with participation by new
and existing investors.
- Announced the resignation of Chief Financial Officer and
Treasurer, Sean Cassidy, effective February 29, 2024.
- Announced the appointment of Randy Teel, Ph.D., Arvinas’
current senior vice president of corporate and business
development, to the role of interim chief financial officer and
treasurer.
- The Arvinas Board of Directors has launched a formal search
process to identify Mr. Cassidy’s permanent replacement.
- Appointed Jared Freedberg, J.D., as general counsel.
- Entered into a new collaboration with
Pfizer to identify novel chemical matter for E3 ligases leveraging
Pfizer’s proprietary compound libraries and Arvinas’ ligase ligand
expertise.
Anticipated Upcoming Milestones and
ExpectationsVepdegestrant (ARV-471)As
part of Arvinas’ global collaboration with Pfizer, the companies
plan to:
- Complete enrollment of the VERITAC-2 Phase 3 monotherapy trial
(ClinicalTrials.gov Identifier: NCT05654623) in patients with
metastatic breast cancer (2H 2024).
- 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.
- Continue enrollment of the ongoing Phase 1b/2 clinical trial
with vepdegestrant plus Pfizer’s novel CDK4 inhibitor (PF-07220060)
(TACTIVE-K: ClinicalTrials.gov Identifier: NCT06206837).
- Continue enrollment of the ongoing Phase 1b combination
umbrella trial evaluating combinations of vepdegestrant with
abemaciclib, ribociclib, or samuraciclib (TACTIVE-U:
ClinicalTrials.gov Identifiers: NCTC05548127, NCTC05573555, and
NCT06125522).
- Initiate discussion with regulatory authorities on a
second-line Phase 3 trial of vepdegestrant in combination with
palbociclib and potentially other CDK4/6 inhibitors, and a new
first-line Phase 3 trial of vepdegestrant plus Pfizer’s novel CDK4
inhibitor (PF-07220060).
ARV-766
- Continue enrollment of Phase 2 dose expansion study with
ARV-766, with progression free survival data anticipated in
mid-2024.
- Continue enrollment of Phase 1b/2 dose escalation trial with
ARV-766 in combination with abiraterone in patients who have not
previously received novel hormonal agents.
- Initiate discussions with regulatory authorities for a planned
Phase 3 clinical trial with ARV-766 in mCRPC (2Q 2024).
Pipeline
- Continue enrollment in Phase 1 clinical trial in healthy
volunteers with LRRK2 targeting PROTAC® ARV-102 (2024)
- Initiate first-in-human Phase 1 clinical trial in B-cell
lymphomas with BCL6 targeting PROTAC® ARV-393 (1H 2024)
Financial GuidanceBased on its current
operating plan, Arvinas believes its cash, cash equivalents,
restricted cash and marketable securities as of December 31,
2023, is sufficient to fund planned operating expenses and capital
expenditure requirements into 2027.
Full Year and Fourth Quarter Financial
Results
Cash, Cash Equivalents and Marketable Securities
Position: As of December 31, 2023, cash, cash equivalents,
restricted cash and marketable securities were $1,266.5 million, as
compared with $1,210.8 million as of December 31, 2022. The
increase in cash, cash equivalents, restricted cash and marketable
securities of $55.7 million for the year was primarily related to
net proceeds from our private placement and ATM offerings of $370.2
million, unrealized gains on marketable securities of $16.1 million
and proceeds from the exercise of stock options and issuance of
ESPP shares of $4.5 million, offset by cash used in operations of
$331.3 million (net of $2.5 million received from two
collaborators), purchases of lab equipment and leasehold
improvements of $2.9 million and losses on the sale of securities
of $0.9 million.
Research and Development Expenses: Research and
development expenses were $379.7 million and $95.2 million for the
year and quarter ended December 31, 2023, as compared with $315.0
million and $98.3 million for the year and quarter ended December
31, 2022. The increase in research and development expenses of
$64.7 million for the year was primarily due to an increase in
expenses associated with our platform and exploratory programs of
$1.1 million, our AR program (which includes ARV-766 and
bavdegalutamide (ARV-110)) of $22.0 million and our ER program of
$41.6 million, which includes the cost sharing of vepdegestrant
(ARV-471) under the Vepdegestrant (ARV-471) Collaboration
Agreement. The decrease in research and development expenses of
$3.1 million for the quarter was primarily due to a decrease in
expenses associated with our platform and exploratory programs of
$19.4 million, offset by increases in our AR program of $5.7
million and our ER program of $10.6 million.
General and Administrative Expenses: General
and administrative expenses were $100.3 million and $27.0 million
for the year and quarter ended December 31, 2023, as compared with
$79.6 million and $15.1 million for the year and quarter ended
December 31, 2022. The increase in general and administrative
expenses of $20.7 million for the year was primarily due to an
increase in personnel and infrastructure related costs of $11.5
million, an increase in professional fees of $6.3 million and
increases related to establishing our commercial operations of $3.5
million, offset in part by reduced insurance costs of $1.0 million.
The increase in general and administrative expenses of $11.9
million for the quarter was primarily due to an increase in
personnel and infrastructure related costs of $8.4 million, an
increase in professional fees of $1.8 million and increases related
to establishing our commercial operations of $1.7 million.
Revenues: Revenue was $78.5 million and $(43.1)
million for the year and quarter ended December 31, 2023 as
compared with $131.4 million and $38.0 million for the year and
quarter ended December 31, 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. The decrease of $52.9 million for the year
was primarily due to adjustments to revenue from changes in
contract estimates related to our Pfizer ARV-471 Collaboration
Agreement, Pfizer Research Collaboration Agreement and Bayer
Collaboration Agreement, net of current year revenues, totaling
$39.7 million, a decrease of $8.1 million in previously constrained
deferred revenue recognized in 2023 related to our Oerth Bio joint
venture and a decrease in revenue recognized from our Genentech
License Agreement of $5.1 million. The decrease of $81.1 million
for the quarter was primarily due to an adjustment to revenue from
a change in contract estimate related to our Pfizer ARV-471
Collaboration Agreement.
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 four investigational
clinical-stage programs: vepdegestrant (ARV-471) for the treatment
of patients with locally advanced or metastatic ER+/HER2- breast
cancer; ARV-766 and bavdegalutamide for the treatment of men with
metastatic castration-resistant prostate cancer; and ARV-102 for
the treatment of patients with neurodegenerative
disorders. 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
plans with respect to an expanded development plan for
vepdegestrant including a new Phase 3 trial in combination with
CDK4/6 inhibitors in the second-line setting and a new Phase 3
trial of vepdegestrant plus Pfizer’s novel CDK4 inhibitor in the
first-line setting, pending further data and discussions with
regulatory authorities; the anticipated timing to complete Arvinas’
first Phase 3 clinical trial with vepdegestrant; the potential,
pending regulatory approval, for vepdegestrant to address an area
of high unmet need and offer patients a new oral treatment option
in the second-line metastatic breast cancer setting; Arvinas’ and
Pfizer’s plans with respect to the timing of ongoing and planned
clinical trials of vepdegestrant, as a monotherapy and in
combination studies, and the initiation of discussions with
regulatory authorities regarding new potential clinical trials;
Arvinas’ plans with respect to its clinical trials of ARV-766, the
anticipated timing of progression free survival data for the Phase
2 dose expansion study of ARV-766 and the initiation of discussions
with regulatory authorities for a planned Phase 3 clinical trials
of ARV-766; Arvinas’ plans with respect to its ARV-102 clinical
trial and timing related to initiating the first-in-human Phase 1
clinical trial in B-cell lymphomas with BCL6 targeting PROTAC®; the
potential advantages and therapeutic benefits of vepdegestrant
(ARV-471), ARV-766, bavdegalutamide, and Arvinas’ other discovery
programs, including LRRK2 and BCL6; 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
its other product candidates, including ARV-766, and 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), 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
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:Kathleen Murphy+1 (760)
622-3771Kathleen.Murphy@arvinas.com
ARVINAS, INC. AND SUBSIDIARIESConsolidated Balance
Sheets (Unaudited) |
|
December 31, |
(dollars and shares in millions, except per share amounts) |
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
311.7 |
|
|
$ |
81.3 |
|
Restricted cash |
|
5.5 |
|
|
|
5.5 |
|
Marketable securities |
|
949.3 |
|
|
|
1,124.0 |
|
Accounts receivable |
|
— |
|
|
|
1.0 |
|
Other receivables |
|
7.2 |
|
|
|
7.0 |
|
Prepaid expenses and other current assets |
|
6.5 |
|
|
|
21.4 |
|
Total current
assets |
|
1,280.2 |
|
|
|
1,240.2 |
|
Property, equipment and
leasehold improvements, net |
|
11.5 |
|
|
|
13.4 |
|
Operating lease right of use
assets |
|
2.5 |
|
|
|
4.4 |
|
Collaboration contract asset
and other assets |
|
10.4 |
|
|
|
10.8 |
|
Total
assets |
$ |
1,304.6 |
|
|
$ |
1,268.8 |
|
Liabilities and
stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
92.2 |
|
|
$ |
74.7 |
|
Deferred revenue |
|
163.0 |
|
|
|
218.6 |
|
Current portion of operating lease liability |
|
1.9 |
|
|
|
1.8 |
|
Total current
liabilities |
|
257.1 |
|
|
|
295.1 |
|
Deferred revenue |
|
386.2 |
|
|
|
405.1 |
|
Long term debt |
|
0.8 |
|
|
|
1.0 |
|
Operating lease liability |
|
0.5 |
|
|
|
2.7 |
|
Total
liabilities |
|
644.6 |
|
|
|
703.9 |
|
Stockholders'
equity: |
|
|
|
Preferred stock, $0.001 par value, zero shares issued and
outstanding as of December 31, 2023 and 2022, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value, 68.0 and 53.2 shares issued and
outstanding as of December 31, 2023 and 2022, respectively |
|
0.1 |
|
|
|
0.1 |
|
Accumulated deficit |
|
(1,332.7 |
) |
|
|
(965.4 |
) |
Additional paid-in capital |
|
1,995.7 |
|
|
|
1,549.4 |
|
Accumulated other comprehensive loss |
|
(3.1 |
) |
|
|
(19.2 |
) |
Total stockholders'
equity |
|
660.0 |
|
|
|
564.9 |
|
Total liabilities and
stockholders' equity |
$ |
1,304.6 |
|
|
$ |
1,268.8 |
|
ARVINAS, INC. AND SUBSIDIARIESConsolidated
Statements of Operations (Unaudited) |
|
Three Months Ended December 31, |
|
Year Ended December 31, |
(dollars and shares in millions, except per share amounts) |
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
(43.1 |
) |
|
$ |
38.0 |
|
|
$ |
78.5 |
|
|
$ |
131.4 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
95.2 |
|
|
|
98.3 |
|
|
|
379.7 |
|
|
|
315.0 |
|
General and administrative |
|
27.0 |
|
|
|
15.1 |
|
|
|
100.3 |
|
|
|
79.6 |
|
Total operating
expenses |
|
122.2 |
|
|
|
113.4 |
|
|
|
480.0 |
|
|
|
394.6 |
|
Loss from
operations |
|
(165.3 |
) |
|
|
(75.4 |
) |
|
|
(401.5 |
) |
|
|
(263.2 |
) |
Interest and other income |
|
12.1 |
|
|
|
6.3 |
|
|
|
37.6 |
|
|
|
12.2 |
|
Net loss before income
taxes and loss from equity method investment |
|
(153.2 |
) |
|
|
(69.1 |
) |
|
|
(363.9 |
) |
|
|
(251.0 |
) |
Income tax expense |
|
(1.6 |
) |
|
|
(10.8 |
) |
|
|
(0.9 |
) |
|
|
(20.9 |
) |
Loss from equity method investment |
|
— |
|
|
|
(3.0 |
) |
|
|
(2.5 |
) |
|
|
(10.6 |
) |
Net loss |
$ |
(154.8 |
) |
|
$ |
(82.9 |
) |
|
$ |
(367.3 |
) |
|
$ |
(282.5 |
) |
Net loss per common
share - basic and diluted |
$ |
(2.53 |
) |
|
$ |
(1.56 |
) |
|
$ |
(6.62 |
) |
|
$ |
(5.31 |
) |
Weighted average
common shares outstanding - basic and diluted |
|
61.1 |
|
|
|
53.2 |
|
|
|
55.5 |
|
|
|
53.2 |
|
Arvinas (NASDAQ:ARVN)
過去 株価チャート
から 4 2024 まで 5 2024
Arvinas (NASDAQ:ARVN)
過去 株価チャート
から 5 2023 まで 5 2024