--The Company will present preliminary data
from RUBY-3 glomerulonephritis clinical study at the American
Society of Nephrology Meeting in November 2023--
Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for autoimmune and inflammatory diseases,
today reported financial results and company highlights for the
second quarter ended June 30, 2023.
“During the first half of 2023 we achieved several important
milestones in the development of povetacicept, our potentially
best-in-class dual BAFF/APRIL inhibitor being advanced in multiple
autoimmune diseases. We are pleased to have initiated patient
enrollment in the RUBY-4 study of povetacicept in autoimmune
cytopenias and continue to be particularly encouraged by the high
level of interest in the RUBY-3 study of povetacicept in autoimmune
glomerulonephritis,” said Mitchell H. Gold, MD, Executive Chairman
and Chief Executive Officer of Alpine. “We look forward to sharing
initial data later this year while we continue to plan for a broad
and accelerated development program for povetacicept across
multiple indications in 2024.”
Second Quarter 2023 Highlights &
Recent Updates
Povetacicept (ALPN-303)
- Initiated and continue to enroll patients in RUBY-4, a phase
1b, open-label study of povetacicept in autoimmune cytopenias,
including immune thrombocytopenia, warm autoimmune hemolytic
anemia, and cold agglutinin disease.
- Continue to enroll patients in RUBY-3, a phase 1b/2a,
open-label study of povetacicept in autoimmune glomerulonephritis,
including IgA nephropathy, lupus nephritis, and primary membranous
nephropathy.
- Povetacicept continues to be administered subcutaneously via a
convenient once every four-week dosing regimen.
- Preliminary clinical data from RUBY-3 will be presented at the
American Society of Nephrology (ASN) Annual Kidney Week Meeting,
November 2-5, 2023, in Philadelphia, PA.
Second Quarter 2023 Financial
Results
Cash Position and Runway: As of June 30, 2023, Alpine’s
cash and investments totaled $239.6 million compared to $273.4
million as of December 31, 2022. The Company anticipates its
current cash and investments are sufficient to fund planned
operations through 2025.
Collaboration Revenue: For the three and six months ended
June 30, 2023, collaboration revenue was $8.6 million and $18.0
million, respectively, compared to $5.3 million and $18.9 million
for the same periods in 2022. The increase in collaboration revenue
over the three-month period relates primarily to increases of $2.2
million in AbbVie revenue and $1.1 million in Horizon revenue due
to continued progress on each program compared to prior year. The
decrease in collaboration revenue for the six months ended June 30,
2023 as compared to the prior year primarily relates to a $3.1
million decrease in Horizon revenue in 2023 due to the completion
of the existing program deliverables in the prior year, partially
offset by a $1.8 million increase in AbbVie revenue due to the
additional progress in the current year.
Research and Development Expenses: For the three and six
months ended June 30, 2023, research and development expenses,
inclusive of non-cash expenses, were $19.2 million and $38.8
million respectively, compared to $17.6 million and $33.9 million
for the same periods in 2022. The respective increases of $1.7
million and $4.9 million were primarily attributable to higher
personnel-related expenses due to increased headcount to support
clinical trial activities.
General and Administrative Expenses: For the three and
six months ended June 30, 2023, general and administrative
expenses, inclusive of non-cash expenses, were $5.0 million and
$10.4 million respectively, compared to $4.2 million and $9.0
million for the same periods in 2022. The respective increases of
$0.8 million and $1.4 million were primarily attributable to
increases in personnel costs.
Net Loss: Net loss for the three and six months ended
June 30, 2023, was $13.2 million and $26.4 million, respectively,
compared to net losses of $18.1 million and $25.6 million for the
same periods in 2022.
Alpine Immune Sciences, Inc.
Selected Condensed Consolidated Balance
Sheet Data
(In thousands)
June 30, 2023
December 31, 2022
(unaudited)
Cash and cash equivalents
$
34,076
$
13,376
Short-term investments
169,724
224,265
Total current assets
207,321
240,993
Long-term investments
35,561
35,481
Total assets
252,836
286,686
Total current liabilities
53,410
57,996
Total stockholders’ equity
169,388
179,420
Total liabilities and stockholders’
equity
252,836
286,686
Condensed Consolidated Statement of
Operations and Comprehensive Income (Loss) Data
(In thousands, except share and per share
amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
(unaudited)
Collaboration revenue
$
8,593
$
5,292
$
17,980
$
18,921
Operating expenses:
Research and development
19,241
17,587
38,822
33,898
General and administrative
5,007
4,194
10,405
8,969
Total operating expenses
24,248
21,781
49,227
42,867
Loss from operations
(15,655
)
(16,489
)
(31,247
)
(23,946
)
Other income (expense):
Interest income
2,528
314
4,946
459
Interest expense
(28
)
(130
)
(98
)
(284
)
Other, net
(1
)
(15
)
(23
)
(72
)
Loss before taxes
(13,156
)
(16,320
)
(26,422
)
(23,843
)
Income tax expense
—
(1,778
)
—
(1,782
)
Net loss
$
(13,156
)
$
(18,098
)
$
(26,422
)
$
(25,625
)
Comprehensive income (loss):
Unrealized (loss) gain on investments
(238
)
(304
)
507
(1,078
)
Unrealized loss on foreign currency
translation
(5
)
(4
)
(36
)
(18
)
Comprehensive loss
$
(13,399
)
$
(18,406
)
$
(25,951
)
$
(26,721
)
Weighted-average shares used to compute
basic and diluted net loss per share
48,049,936
30,324,933
47,810,374
30,311,527
Basic and diluted net loss per share
$
(0.27
)
$
(0.60
)
$
(0.55
)
$
(0.85
)
About Povetacicept (ALPN-303)
Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell
activating factor) and APRIL (a proliferation inducing ligand)
cytokines, which play key roles in pathogenesis of multiple
autoimmune diseases via their roles in the activation,
differentiation and/or survival of B cells, particularly
antibody-secreting cells, as well as T cells and innate immune
cells. Based upon an engineered TACI (transmembrane activator and
CAML interactor) domain, povetacicept has exhibited greater potency
in preclinical studies versus wild-type TACI-based comparators, as
well as other inhibitors of BAFF and/or APRIL alone. Povetacicept
is in development for multiple autoimmune diseases, such as
systemic lupus erythematosus, autoimmune glomerulonephritis, and
autoimmune cytopenias.
About RUBY-3
RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort,
open label, phase 1b/2a study of povetacicept in IgA nephropathy,
lupus nephritis, and primary membranous nephropathy, where
povetacicept is being administered subcutaneously for up to 48
weeks. Key endpoints include proteinuria, eGFR, renal response, and
disease-related autoantibodies.
About RUBY-4
RUBY-4 (NCT05757570) is a multi-cohort, open label, phase 1b
study of povetacicept in immune thrombocytopenia, autoimmune
hemolytic anemia, and cold agglutinin disease, where povetacicept
is being administered subcutaneously for up to 48 weeks. Key
endpoints include respective blood cell counts, including durable
responses, as well as disease-related autoantibodies.
About Alpine Immune
Sciences
Alpine Immune Sciences is committed to leading a new wave of
immune therapeutics. With world-class research and development
capabilities, a highly productive scientific platform, and a proven
management team, Alpine is seeking to create first- or
best-in-class multifunctional immunotherapies via unique protein
engineering technologies to improve patients’ lives. Alpine has
entered into strategic collaborations with leading global
biopharmaceutical companies and has a diverse pipeline of clinical
and preclinical candidates in development. For more information,
visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on
Twitter and LinkedIn.
Forward-Looking
Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding our
platform technology and potential therapies; the timing of and
results from clinical trials and preclinical development
activities; clinical and regulatory objectives and the timing
thereof; expectations regarding the sufficiency of cash, cash
equivalents, restricted cash, and investments to fund our planned
operations through 2025; the potential efficacy, safety profile,
future development plans, addressable market, regulatory success,
and commercial potential of our product candidates; our ability to
achieve additional milestones in our collaborations and proprietary
programs; the progress and potential of our ongoing development
programs; the timing of our public presentations and potential
publication of future clinical data; the efficacy of our clinical
trial designs; anticipated enrollment in our clinical trials and
the timing thereof; expectations regarding our ongoing
collaborations; and our ability to successfully develop and achieve
milestones in our development programs. Forward-looking statements
generally include statements that are predictive in nature and
depend upon or refer to future events or conditions and include
words such as “may,” “will,” “should,” “would,” “expect,” “plan,”
“intend,” and other similar expressions, among others. These
forward-looking statements are based on current assumptions that
involve risks, uncertainties, and other factors that may cause
actual results, events, or developments to be materially different
from those expressed or implied by such forward-looking statements.
These risks and uncertainties, many of which are beyond our
control, include, but are not limited to: clinical trials may not
demonstrate safety and efficacy of any of our product candidates;
our ongoing discovery and preclinical efforts may not yield
additional product candidates; our discovery-stage and preclinical
programs may not advance into the clinic or result in approved
products; any of our product candidates may fail in development,
may not receive required regulatory approvals, or may be delayed to
a point where they are not commercially viable; we may not achieve
additional milestones in our proprietary or partnered programs; the
impact of competition; adverse conditions in the general domestic
and global economic markets; the impact of pandemics, or other
related health crises on our business, research and clinical
development plans and timelines and results of operations,
including the impact on our clinical trial sites, collaborators,
and contractors who act for or on our behalf; as well as the other
risks identified in our filings with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date hereof and we undertake no obligation to update
forward-looking statements, and readers are cautioned not to place
undue reliance on such forward-looking statements.
The RUBY and Alpine logos are registered trademarks of Alpine
Immune Sciences, Inc. in various jurisdictions.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814825100/en/
Investor and Media Contact: Temre Johnson Alpine Immune
Sciences, Inc. ir@alpineimmunesciences.com
media@alpineimmunesciences.com
Alpine Immune Sciences (NASDAQ:ALPN)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Alpine Immune Sciences (NASDAQ:ALPN)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024