-- First clinical data with povetacicept
presented at American Society of Nephrology Kidney Week support
best-in-class potential and broad pipeline opportunity –
-- Company closed an oversubscribed $150
million equity offering to accelerate multiple development
activities –
-- Multiple catalysts with povetacicept
targeted in 2024 including initiation of pivotal IgAN and phase 2
lupus clinical trials --
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
third quarter ended September 30, 2023.
“The first presentation of clinical data in patients for
povetacicept during a late-breaking session at the American Society
of Nephrology (ASN) Kidney Week Meeting marked an important
milestone in Alpine’s history. Based on continued strong support
from investigators and key opinion leaders, we plan to advance
povetacicept into a pivotal study in IgA nephropathy (IgAN) and a
phase 2 study in systemic lupus erythematosus (SLE) in the second
half of 2024,” said Mitchell Gold, MD, Executive Chairman and Chief
Executive Officer of Alpine. “Following our data presentation, we
executed a follow-on equity offering of $150 million to bolster our
balance sheet. The additional capital enables us to further
accelerate development activities, including povetacicept, across
multiple autoantibody-related diseases.”
Dr. Gold continued, “These initial data and the subsequent
follow-on offering set the stage for an active, catalyst-heavy
2024, with additional data expected in IgAN that will include
longer term follow-up from our low-dose cohort and initial data
from our high-dose cohort. In addition, we look forward to sharing
initial data from povetacicept in autoimmune cytopenias. We believe
povetacicept, which is a wholly-owned program, represents a unique,
potentially best-in-class molecule and look forward to using our
strong balance sheet to support a broad development plan across
multiple indications.”
Third Quarter 2023 Highlights &
Recent Updates
Highlights From Data Presented at the
American Society of Nephrology (ASN) Kidney Week
- In IgAN, treatment with low-dose povetacicept, 80 mg
subcutaneously (SC) every four weeks was associated with clinically
meaningful improvements in proteinuria, with a 53.5% reduction from
baseline in urine protein to creatinine ratio (UPCR; n=5) at 24
weeks. In addition, at 24 weeks, 4/5 (80%) had achieved remission,
as defined as UPCR < 0.5 g/g and ≥ 50% reduction in UPCR from
baseline with stable renal function (£ 25% reduction in eGFR from
baseline).
- In IgAN, treatment with low-dose povetacicept was also
associated with a >60% reduction in the key disease-related
biomarker galactose-deficient IgA1 (Gd-IgA1), as well as stable
renal function as assessed by estimated glomerular filtration rate
(eGFR) (+7.1% from baseline at 24 weeks; n=5).
- The first participant with primary membranous nephropathy
(pMN), also treated with povetacicept 80 mg subcutaneously (SC)
every four weeks, achieved an immunological remission, defined as a
reduction in the highly disease-relevant biomarker anti-PLA2R1 to
an undetectable level, from a baseline of 209 to < 2 RU/mL by 22
weeks.
- Povetacicept has been well tolerated, with no reported
administration-associated reactions, no instances of IgG < 3
g/L, and no severe infections.
- A higher dose of povetacicept, 240 mg SC every four weeks,
continues to enroll, with initial data expected in first half of
2024.
- Link to the ASN poster: https://bit.ly/3SHhuDx
Highlights From Data Presented at the
American Association of Neuromuscular & Electrodiagnostic
(AANEM) Medicine Meeting
- In a model of murine experimental autoimmune myasthenia gravis
(EAMG), povetacicept improved disease activity, with clinical
scores superior to treatment with either the FcRn inhibitor
efgartigimod or an anti-CD20 depleting antibody. It also reduced
anti-AChR IgG autoantibodies and serum Ig isotypes, including IgM
and IgA, superior to both comparator treatments.
- Link to the AANEM poster: https://bit.ly/3MrvlK2
Highlights From Data Presented at the American College of Rheumatology
(ACR) Meeting
- In SLE patients, BAFF- and APRIL-related genes (i.e., BAFF,
APRIL, TACI, and BCMA) were increased in myeloid lineage cells and
B cells compared to healthy adults.
- Povetacicept, as compared to single BAFF or APRIL pathway
inhibitors, more potently downregulated genes associated with
activation in B cells.
- Povetacicept significantly reduced multiple disease parameters
in a mouse model of lupus, more effectively than wild-type TACI-Fc
or conventional B cell depletion.
- Link to povetacicept poster: https://bit.ly/3ssynXM
Third Quarter 2023 Financial
Results
Cash Position and Runway: As of September 30, 2023,
Alpine’s cash and investments totaled $227.2 million compared to
$273.4 million as of December 31, 2022. The Company anticipates its
current cash and investments, together with the $140.5 million in
net proceeds after deducting discounts, commissions and estimated
costs from the subsequently completed stock offering, are
sufficient to fund planned operations into 2026.
Collaboration Revenue: For the three and nine months
ended September 30, 2023, collaboration revenue was $10.0 million
and $28.0 million, respectively, compared to $8.4 million and $27.3
million for the same periods in 2022. The increase in collaboration
revenue over the three-month period relates primarily to increases
of $3.5 million in Horizon revenue, largely as the result of our
two ongoing Research Programs nearing completion during the 2023
period, whereas the lower revenue during the 2022 period resulted
from services rendered in connection with only the first Research
Program. These increases were offset by decreases in AbbVie revenue
of $1.4 million primarily due to lower contributed employee hours.
The increase in collaboration revenue for the nine months ended
September 30, 2023, as compared to the prior year, primarily
relates to increases in AbbVie revenue as the related clinical
trial continues patient enrollment, and Horizon revenue for
services rendered in connection with our two ongoing Research
programs, whereas the lower Horizon revenue in the 2022 period was
primarily the result of the completion of the Existing Program,
followed by the commencement of the first additional research
program.
Research and Development Expenses: For the three and nine
months ended September 30, 2023, research and development expenses,
inclusive of non-cash expenses, were $19.2 million and $58.0
million, respectively, compared to $17.6 million and $51.5 million
for the same periods in 2022. The respective increases of $1.6
million and $6.5 million were primarily attributable to process
development, manufacturing, higher clinical trial costs, as well as
increases in personnel costs.
General and Administrative Expenses: For the three and
nine months ended September 30, 2023, general and administrative
expenses, inclusive of non-cash expenses, were $5.4 million and
$15.8 million, respectively, compared to $4.6 million and $13.6
million for the same periods in 2022. The respective increases of
$0.8 million and $2.3 million were primarily attributable to
increases in personnel and legal costs.
Net Loss: Net loss for the three and nine months ended
September 30, 2023, was $11.7 million and $38.1 million,
respectively, compared to net losses of $13.3 million and $38.9
million for the same periods in 2022.
Alpine Immune Sciences, Inc.
Selected Condensed Consolidated Balance
Sheet Data
(In thousands)
September 30, 2023
December 31, 2022
(unaudited)
Cash and cash equivalents
$
18,981
$
13,376
Short-term investments
174,472
224,265
Total current assets
197,415
240,993
Long-term investments
33,502
35,481
Total assets
240,547
286,686
Total current liabilities
51,818
57,996
Total stockholders’ equity
161,631
179,420
Total liabilities and stockholders’
equity
240,547
286,686
Condensed Consolidated Statement of
Operations and Comprehensive Income (Loss) Data
(In thousands, except share and per share
amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
(unaudited)
Collaboration revenue
$
10,043
$
8,367
$
28,023
$
27,288
Operating expenses:
Research and development
19,150
17,589
57,972
51,487
General and administrative
5,443
4,610
15,848
13,579
Total operating expenses
24,593
22,199
73,820
65,066
Loss from operations
(14,550
)
(13,832
)
(45,797
)
(37,778
)
Other income (expense):
Interest income
2,891
664
7,837
1,123
Interest expense
—
(105
)
(98
)
(389
)
Other, net
(63
)
—
(86
)
(72
)
Loss before taxes
(11,722
)
(13,273
)
(38,144
)
(37,116
)
Income tax expense
—
—
—
(1,782
)
Net loss
$
(11,722
)
$
(13,273
)
$
(38,144
)
$
(38,898
)
Comprehensive income (loss):
Unrealized gain (loss) on investments
170
(307
)
677
(1,385
)
Unrealized (loss) gain on foreign currency
translation
(60
)
7
(96
)
(11
)
Comprehensive loss
$
(11,612
)
$
(13,573
)
$
(37,563
)
$
(40,294
)
Weighted-average shares used to compute
basic and diluted net loss per share
49,222,344
31,574,358
48,286,203
31,559,886
Basic and diluted net loss per share
$
(0.24
)
$
(0.42
)
$
(0.79
)
$
(1.23
)
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 other inhibitors of BAFF and/or APRIL
alone and B cell depletion. Povetacicept is in development for
multiple autoimmune diseases, including IgA nephropathy and other
autoimmune kidney diseases, systemic lupus erythematosus, 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 autoimmune
glomerulonephritis, 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 X
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, along with proceeds
from our November 2023 follow-on equity offering, to fund our
planned operations into 2026; our ability to achieve additional
milestones in our collaborations and proprietary programs; the
progress and potential of our development programs; future
development plans and clinical and regulatory milestones and
objectives, including the timing and achievement thereof; the
efficacy of our clinical trial designs; anticipated enrollment in
our clinical trials and the timing thereof; expectations regarding
the anticipated reporting of data from our ongoing and planned
clinical trials and potential publication of future clinical data;
our ability to potentially advance povetacicept directly into a
pivotal trial in 2024 as well as a phase 2 study in systemic lupus
erythematosus, pending engagement with and approval of the Food and
Drug Administration; and the potential efficacy, safety profile,
addressable market, regulatory success and commercial or
therapeutic potential of our product candidates. 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; we may be unable to advance
povetacicept directly into a pivotal trial or a phase 2 study in
systemic lupus erythematosus in 2024; 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/20231114086515/en/
Investor and Media Contact: Temre Johnson Alpine Immune
Sciences, Inc. ir@alpineimmunesciences.com
media@alpineimmunesciences.com
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