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 for the first quarter ended March
31, 2023.
“So far this year, we have achieved important milestones in
advancing clinical studies for povetacicept, our potential
best-in-class dual BAFF/APRIL inhibitor being developed for
multiple autoantibody-related diseases. The first participant was
dosed in the RUBY-3 study of povetacicept in autoimmune
glomerulonephritis and we are pleased with the high level of
investigator interest in the study. We’ve also opened the RUBY-4
study of povetacicept in autoimmune cytopenias and are preparing to
initiate enrollment this quarter,” said Mitchell H. Gold, MD,
Executive Chairman and Chief Executive Officer of Alpine. “We
remain on track to deliver preliminary data from both the RUBY-3
and RUBY-4 studies by the end of the year as we continue to pursue
our mission of bringing meaningful new therapies to people living
with autoimmune or inflammatory diseases.”
First Quarter 2023
Highlights
Povetacicept (ALPN-303)
- Initiated and continues to enroll participants in RUBY-3, a
phase 1b, open-label basket study of povetacicept in autoimmune
glomerulonephritis, including IgA nephropathy, lupus nephritis, and
primary membranous nephropathy.
- Advanced preparations for initiating enrollment in RUBY-4, a
phase 1b, open-label basket study of povetacicept in autoimmune
cytopenias, including immune thrombocytopenia, warm autoimmune
hemolytic anemia, and cold agglutinin disease.
- Presented encore phase 1 data from the RUBY-1 study of
povetacicept in healthy adults in an ePoster and oral presentation
at the American Academy of Dermatology Annual Meeting and in a
poster session at the International Society of Nephrology World
Congress of Nephrology.
- Presented pharmacokinetic and pharmacodynamic modeling and
simulation data to support clinical development of povetacicept in
a poster session at the American Society for Clinical Pharmacology
& Therapeutics Annual Meeting.
- Plans to present an updated clinical dataset from the RUBY-1
study in healthy adult volunteers at the European Alliance of
Associations for Rheumatology (EULAR) 2023 Congress in June.
First Quarter 2023 Financial
Results
As of March 31, 2023, Alpine’s cash and investments totaled
$248.3 million, which the Company anticipates is sufficient to fund
its planned operations through 2025. The Company recorded net
losses of $13.3 million and $7.5 million for the quarters ended
March 31, 2023 and 2022, respectively.
Collaboration revenue for the first quarter ended March 31, 2023
was $9.4 million compared to $13.6 million for the first quarter
ended March 31, 2022.
The decrease in collaboration revenue relates primarily to the
Company’s agreement with Horizon. Horizon collaboration revenues
for the three-months period ended March 31, 2023 decreased by $4.2
million related to services rendered in connection with the
Company’s two ongoing research programs for Horizon, whereas the
higher 2022 period revenues were the result of substantial
completion of the initial existing program with Horizon.
Research and development expenses for the first quarter ended
March 31, 2023 were $19.6 million compared to $16.3 million for the
first quarter ended March 31, 2022. The increase was primarily
attributable to higher personnel-related expenses due to increased
headcount to support clinical trial activities.
General and administrative expenses for the first quarter ended
March 31, 2023 were $5.4 million compared to $4.8 million for the
first quarter ended March 31, 2022. The increase was primarily
attributable to increases in personnel costs.
Alpine Immune Sciences, Inc.
Selected Consolidated Balance Sheet
Data
(In thousands)
March 31, 2023
December 31, 2022
(unaudited)
Cash and cash equivalents
$14,465
$13,376
Short-term investments
180,460
224,265
Total current assets
198,784
240,993
Long-term investments
53,170
35,481
Total assets
262,100
286,686
Total current liabilities
57,089
57,996
Total stockholders’ equity
169,543
179,420
Total liabilities and stockholders’
equity
262,100
286,686
Consolidated Statement of Operations and
Comprehensive Income (Loss) Data
(In thousands, except share and per share
amounts)
Three Months Ended March
31,
2023
2022
(unaudited)
Collaboration revenue
$9,387
$13,629
Operating expenses:
Research and development
19,581
16,311
General and administrative
5,398
4,775
Total operating expenses
24,979
21,086
Loss from operations
(15,592)
(7,457)
Other income (expense):
Interest income
2,418
145
Interest expense
(70)
(154)
Other, net
(22)
(57)
Loss before taxes
(13,266)
(7,523)
Income tax benefit (expense)
—
(4)
Net loss
$(13,266)
$(7,527)
Comprehensive income (loss):
Unrealized gain (loss) on investments
745
(774)
Unrealized loss on foreign currency
translation
(31)
(14)
Comprehensive loss
$(12,552)
$(8,315)
Weighted-average shares used to compute
basic and diluted net loss per share
47,568,149
30,267,472
Basic and diluted net loss per share
$(0.28)
$(0.25)
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 the activation and survival of B
cells, particularly antibody-secreting 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 B cell and/or autoantibody-related
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 study of povetacicept in IgA nephropathy,
lupus nephritis, and primary membranous nephropathy, where
povetacicept is being administered for up to 48 weeks in disease-
and dose-specific cohorts. 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 for up to 48 weeks in disease-specific
cohorts. 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 the COVID-19 pandemic 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, may be more severe and prolonged than currently
anticipated; 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/20230511005907/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