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, 2024, and provided a corporate update.
“During the second quarter, we continued making meaningful
progress across our entire portfolio, with upcoming milestones that
will further support our mission to improve patient lives with
pioneering therapies from our revolutionary PROTAC® protein
degradation platform,” said John Houston, Ph.D., Chairperson, Chief
Executive Officer and President at Arvinas. “The readout of
VERITAC-2, our first Phase 3 clinical trial, will be a landmark
event for Arvinas. We are on-track to complete enrollment in the
fourth quarter of the year, with topline data anticipated in either
the fourth quarter of 2024 or first quarter of 2025. If positive,
we believe these results will support our first new drug
application filing and our transition to a commercial-stage
company, assuming regulatory approval.”
“We are well on our way to becoming a multi-product,
commercial-stage organization with strong leadership and a robust
pipeline across several indications,” continued Dr. Houston. “Our
first PROTAC degrader with the potential to treat neurodegenerative
diseases, ARV-102, was recently cleared to initiate the multiple
ascending dose portion of our Phase 1 clinical trial. In addition,
we initiated the first-in-human Phase 1 clinical trial in patients
with B-cell lymphomas with our PROTAC BCL6 degrader ARV-393. I’m
excited by the progress we have made and the ongoing confidence we
have in our PROTAC platform, which was further validated by our
recent strategic transaction with Novartis. We believe Novartis
will accelerate and broaden the development of ARV-766 as a
potential best-in-class treatment for patients with prostate
cancer.”
Recent Developments and 2Q Business
Highlights
Vepdegestrant
- Evaluated enrollment and blinded event rates in the ongoing
VERITAC-2 Phase 3 monotherapy clinical trial (NCT05654623) in
patients with metastatic breast cancer.
- The trial is on track to complete enrollment in 4Q24.
- Based on current trial status, the primary completion date has
been reprojected to November 2024, with topline data now
anticipated in 4Q24/1Q25.
- Completed enrollment of the study lead-in for the VERITAC-3
Phase 3 clinical trial of vepdegestrant in combination with
palbociclib as a first-line treatment in patients with estrogen
receptor (ER) positive/human growth epidermal growth factor 2
(HER2) negative (ER+/HER2-) locally advanced or metastatic breast
cancer.
- Continued enrollment globally in multiple clinical studies of
vepdegestrant in ER+/HER2- metastatic breast cancer.
- Presented updated clinical data from a Phase 1b clinical trial
combination cohort evaluating vepdegestrant in combination with
palbociclib in heavily pre-treated patients with locally advanced
or metastatic ER+/HER2- breast cancer at the 2024 European Society
for Medical Oncology (ESMO) Breast Cancer Annual Congress.
- After six months of additional follow-up, updated data from the
trial continued to demonstrate an encouraging clinical benefit
rate, objective response rate and progression-free survival, and a
consistent safety profile as previously reported at the San Antonio
Breast Cancer Symposium (SABCS) in December 2023.
- The clinical benefit rate across all dose levels (n=46) was
63%; the objective response rate in evaluable patients with
measurable disease at baseline (n=31) was 42%; median
progression-free survival based on 27 (59%) events across all dose
levels was 11.2 months (95% CI: 8.2 – 16.5) and the safety profile
of vepdegestrant in combination with palbociclib were consistent
with data previously reported at SABCS in December 2023.
- Patients receiving the recommended Phase 3 dose of
vepdegestrant (200mg) in combination with palbociclib 125mg (n=21),
achieved a median progression-free survival of 13.9 months (95% CI:
8.1-NR).
Strategic Transaction with Novartis
- Entered into a license agreement and asset purchase agreement
with Novartis (NYSE: NVS) for the exclusive, worldwide development,
manufacture and commercialization of ARV-766, Arvinas’ second
generation PROTAC® androgen receptor (AR) degrader for patients
with prostate cancer, and the sale of Arvinas’ preclinical AR-V7
program, which closed on May 28, 2024.
- Arvinas received a one-time, upfront
payment in the aggregate amount of $150.0 million in accordance
with the terms of the license agreement and the asset purchase
agreement. Under the terms of the license agreement, Arvinas is
also eligible to receive up to an additional $1.01 billion as
contingent payments based on specified development, regulatory, and
commercial milestones for ARV-766 being met, as well as tiered
royalties based upon worldwide net sales of ARV-766.
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader
- Presented preclinical data at the Biennial International LRRK2
Meeting further supporting the potential of PROTAC-induced
leucine-rich repeat kinase 2 (LRRK2) degradation as a potential
treatment for neurodegenerative diseases. Key findings included:
- With Arvinas' PROTAC LRRK2 degrader, near-complete LRRK2 target
engagement, as well as LRRK2 degradation, in mouse and non-human
primate lung and brain.
- Differing effects of the LRRK2 PROTAC degraders in the lungs
compared to kinase inhibitors, suggesting reduced pulmonary
function risk.
- Substantially less Type II pneumocyte enlargement compared to
MLi-2, an experimental LRRK2 kinase inhibitor.
- Surfactant protein accumulation in mouse lung observed after
treatment with the LRRK2 kinase inhibitor MLi-2, but not after
treatment with the PROTAC LRRK2 degrader.
- No evidence of collagen deposition in lung to date with PROTAC
LRRK2 degraders in non-human primates.
- Received health authority approval to initiate the multiple
ascending dose portion of the ongoing Phase 1 clinical trial in
healthy volunteers with the PROTAC LRRK2 degrader ARV-102.
ARV-393: Oral PROTAC BCL6 degrader
- Presented preclinical data for ARV-393 at the European
Hematology Association 2024 Annual Congress that showed ARV-393:
- Potently and rapidly degraded the BCL6 protein and inhibited
cell growth in diffuse large B-cell lymphoma (DLBCL) and Burkitt
cell lines.
- Showed tumor growth inhibition, including tumor regression, in
various DLBCL cell line-derived xenograft (CDX) models and in
multiple patient-derived xenograft (PDX) models of non-Hodgkin
lymphoma (NHL), including germinal center B-cell-like (GCB),
activated B-cell (ABC), GCB/ABC, BCL not otherwise specified
(BCL/NOS) subtypes of DLBCL, and Burkitt lymphoma.
- Initiated the first-in-human Phase 1 clinical trial in patients
with B-cell lymphomas with PROTAC BCL6 degrader ARV-393.
Corporate
- Announced the appointment of Andrew Saik, MBA, to the role of
Chief Financial Officer.
- Announced the promotion of Ian Taylor, Ph.D., to President of
Research and Development.
- Announced the promotion of Angela Cacace, Ph.D., to Chief
Scientific Officer.
- Announced the promotion of Randy Teel, Ph.D., to Chief Business
Officer.
Anticipated Upcoming Milestones and
Expectations
Vepdegestrant (ARV-471)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.
- Evaluate data from the study lead-in of the VERITAC-3 Phase 3
trial to support dose selection for vepdegestrant plus palbociclib
in planned Phase 3 combination trials in patients with ER+/HER2-
locally advanced or metastatic breast cancer (2H24).
- Present initial safety and pharmacokinetic data from the
abemaciclib arm of the ongoing TACTIVE-U trial (2H24).
- 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).
- Continue enrollment and evaluate preliminary data from the
ongoing clinical trial with vepdegestrant plus Pfizer’s novel CDK4
inhibitor atirmociclib (TACTIVE-K; ClinicalTrials.gov Identifier:
NCT06206837) to inform the study design for the planned Phase 3
first line combination trial with either atirmociclib or
palbociclib, with planned initiation in 2025.
Pipeline
- Continue enrollment in the single ascending dose portion of the
Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2
degrader ARV-102 and begin enrolling the multiple ascending dose
portion by the end of 2024.
- Continue enrollment in the first-in-human Phase 1 clinical
trial in patients with B-cell lymphomas with PROTAC BCL6 degrader
ARV-393.
Financial Guidance Based on its current
operating plan, Arvinas believes its cash, cash equivalents,
restricted cash and marketable securities as of June 30, 2024, is
sufficient to fund planned operating expenses and capital
expenditure requirements into 2027.
Second Quarter Financial ResultsCash,
Cash Equivalents, Restricted Cash and Marketable Securities
Position: As of June 30, 2024, cash, cash equivalents,
restricted cash and marketable securities were $1,234.2 million as
compared with $1,266.5 million as of December 31, 2023. The
decrease in cash, cash equivalents, restricted cash and marketable
securities of $32.3 million for the six months ended June 30, 2024
was primarily related to cash used in operations of $36.0 million
(net of $150.0 million received from the Novartis agreements),
unrealized losses on marketable securities of $0.7 million and the
purchase of lab equipment and leasehold improvements of $0.8
million, partially offset by proceeds from the exercise of stock
options of $5.3 million.
Research and Development Expenses: Research and
development expenses were $93.7 million for the quarter ended June
30, 2024, as compared with $103.4 million for the quarter ended
June 30, 2023. The decrease in research and development expenses of
$9.7 million for the quarter was primarily due to decreases in
expenses related to our ER program (which includes the cost sharing
of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration
Agreement with Pfizer) of $6.6 million and our platform and
exploratory programs of $5.7 million, partially offset by an
increase in our AR program (which includes ARV-766 and
bavdegalutamide (ARV-110)) of $2.6 million.
General and Administrative Expenses: General
and administrative expenses were $31.3 million for the quarter
ended June 30, 2024, as compared with $25.7 million for the quarter
ended June 30, 2023. The increase in general and administrative
expenses of $5.6 million for the quarter was primarily due to an
increase in personnel and infrastructure related costs of $4.0
million and professional fees of $1.6 million.
Revenues: Revenues were $76.5 million for the
quarter ended June 30, 2024, as compared with $54.5 million for the
quarter ended June 30, 2023. Revenue for the quarter is related to
the license agreement and the asset purchase agreement with
Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with
Pfizer, the collaboration and license agreement with Bayer, the
collaboration and license agreement with Pfizer, and revenue
related to our Oerth Bio joint venture. The increase in revenue of
$22.0 million was primarily due to revenue from the Novartis
agreements, which were entered into during the quarter, of $45.4
million, offset by a decrease in revenue from the Vepdegestrant
(ARV-471) Collaboration Agreement with Pfizer of $22.2 million and
a decrease of $1.3 million of previously constrained deferred
revenue related to our Oerth Bio joint venture.
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-102, targeting LRRK2 for
neurodegenerative disorders; and ARV-393, targeting BCL6 for
relapsed/refractory non-Hodgkin Lymphoma. 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 readout of topline data from the VERITAC-2 clinical trial,
submission of Arvinas’ first new drug application filing and
transition to a commercial-stage company, assuming regulatory
approval, the availability and timing of data from other clinical
trials, the receipt of milestone and royalty payments in connection
with the transaction with Novartis and the future development,
potential marketing approval and commercialization of ARV-766,
the potential of Arvinas’ PROTAC protein degrader platform and its
potential to deliver new treatments, Arvinas’ and Pfizer’s plans to
determine the recommended palbociclib dose to be combined with
vepdegestrant in the planned Phase 3 combination trials in patients
with ER+/HER2- locally advanced or metastatic breast cancer, and
statements regarding Arvinas’ cash, cash equivalents, restricted
cash 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,” “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 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 and other product candidates on
current timelines or at all; Arvinas’ and Novartis’ performance of
their respective obligations under the license agreement; whether
Novartis will be able to successfully conduct and complete clinical
development, obtain marketing approval for and commercialize
ARV-766; 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) |
June 30,2024 |
December 31,2023 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
154.8 |
|
$ |
311.7 |
|
Restricted cash |
|
5.5 |
|
|
5.5 |
|
Marketable securities |
|
1,073.9 |
|
|
949.3 |
|
Other receivables |
|
10.0 |
|
|
7.2 |
|
Prepaid expenses and other current assets |
|
12.5 |
|
|
6.5 |
|
Total current assets |
|
1,256.7 |
|
|
1,280.2 |
|
Property,
equipment and leasehold improvements, net |
|
9.8 |
|
|
11.5 |
|
Operating
lease right of use assets |
|
1.5 |
|
|
2.5 |
|
Collaboration contract asset and other assets |
|
11.6 |
|
|
10.4 |
|
Total assets |
$ |
1,279.6 |
|
$ |
1,304.6 |
|
Liabilities and stockholders' equity |
|
|
Current liabilities: |
|
|
Accounts payable and accrued liabilities |
$ |
78.1 |
|
$ |
92.2 |
|
Deferred revenue |
|
267.9 |
|
|
163.0 |
|
Current portion of operating lease liabilities |
|
1.2 |
|
|
1.9 |
|
Total current liabilities |
|
347.2 |
|
|
257.1 |
|
Deferred
revenue |
|
331.3 |
|
|
386.2 |
|
Long term
debt |
|
0.7 |
|
|
0.8 |
|
Operating
lease liabilities |
|
0.2 |
|
|
0.5 |
|
Total liabilities |
|
679.4 |
|
|
644.6 |
|
Stockholders’ equity: |
|
|
Preferred stock, $0.001 par value, zero shares issued and
outstanding as of June 30, 2024 and December 31, 2023,
respectively |
|
— |
|
|
— |
|
Common stock, $0.001 par value; 68.6 and 68.0 shares issued and
outstanding as of June 30, 2024 and December 31, 2023,
respectively |
|
0.1 |
|
|
0.1 |
|
Accumulated deficit |
|
(1,437.3 |
) |
|
(1,332.7 |
) |
Additional paid-in capital |
|
2,041.2 |
|
|
1,995.7 |
|
Accumulated other comprehensive loss |
|
(3.8 |
) |
|
(3.1 |
) |
Total stockholders’ equity |
|
600.2 |
|
|
660.0 |
|
Total liabilities and stockholders’ equity |
$ |
1,279.6 |
|
$ |
1,304.6 |
|
|
|
|
Arvinas,
Inc. |
Condensed
Consolidated Statements of Operations (Unaudited) |
|
|
|
|
|
|
Three Months EndedJune 30, |
Six Months EndedJune 30, |
(dollars and shares in millions, except per share amounts) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenue |
$ |
76.5 |
|
$ |
54.5 |
|
$ |
101.8 |
|
$ |
87.0 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
93.7 |
|
|
103.4 |
|
|
178.0 |
|
|
198.6 |
|
General and administrative |
|
31.3 |
|
|
25.7 |
|
|
55.6 |
|
|
50.7 |
|
Total operating expenses |
|
125.0 |
|
|
129.1 |
|
|
233.6 |
|
|
249.3 |
|
Loss
from operations |
|
(48.5 |
) |
|
(74.6 |
) |
|
(131.8 |
) |
|
(162.3 |
) |
Interest and
other income |
|
13.5 |
|
|
9.0 |
|
|
27.5 |
|
|
15.5 |
|
Net
loss before income taxes and loss from equity method
investment |
|
(35.0 |
) |
|
(65.6 |
) |
|
(104.2 |
) |
|
(146.8 |
) |
Income tax (expense) benefit |
|
(0.2 |
) |
|
0.3 |
|
|
(0.3 |
) |
|
0.7 |
|
Loss from equity method investment |
|
— |
|
|
(1.3 |
) |
|
— |
|
|
(2.4 |
) |
Net
loss |
$ |
(35.2 |
) |
$ |
(66.6 |
) |
$ |
(104.6 |
) |
$ |
(148.5 |
) |
Net
loss per common share, basic and diluted |
$ |
(0.49 |
) |
$ |
(1.25 |
) |
$ |
(1.46 |
) |
$ |
(2.78 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
71.9 |
|
|
53.4 |
|
|
71.7 |
|
|
53.4 |
|
|
|
|
|
|
Grafico Azioni Arvinas (NASDAQ:ARVN)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Arvinas (NASDAQ:ARVN)
Storico
Da Set 2023 a Set 2024