Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for autoimmune and inflammatory diseases,
today provided a corporate update and reported financial results
for the third quarter ended September 30, 2022.
“During our inaugural R&D Day and throughout subsequent
scientific meetings this fall, we have shared promising nonclinical
and clinical data that supports the best-in-class potential for our
lead program ALPN-303 in multiple autoimmune and inflammatory
indications. In particular, recent data from healthy volunteers
presented at ASN's Kidney Week demonstrated dose-dependent
reductions in Gd-IgA1, a key effector molecule and clinical
biomarker of disease progress in IgAN, and the first clinical
disease-related biomarker data with ALPN-303,” said Mitchell H.
Gold, MD, Executive Chairman and Chief Executive Officer of Alpine.
“To further accelerate development of this promising program in
multiple indications, we completed a successful $113 million
follow-on offering with top-tier investors in October, extending
our cash runway through the end of 2025. We now look forward to
beginning a broad development plan for ALPN-303, including a phase
2 study in systemic lupus erythematosus (SLE). In addition, we are
particularly excited to begin open-label basket studies in
glomerulonephritis and autoimmune cytopenias as they should provide
a rapid assessment in multiple diseases and may potentially enable
multiple accelerated development paths.”
Gold continued, “As previously announced, we have voluntarily
terminated enrollment in the davoceticept (ALPN-202) clinical
studies. We would like to thank the patients and investigators who
participated in the NEON studies. We remain focused on using our
resources to further advance ALPN-303, as well as acazicolcept
(ALPN-101) in SLE in collaboration with AbbVie.”
Third Quarter 2022 and Recent Pipeline
and Corporate Updates
ALPN-303
- During the September R&D Day, the Company shared updated
preliminary data from the phase 1 study (RUBY-1) of ALPN-303 in
healthy volunteers and presented a broad development plan,
including a proof-of-concept phase 2 study in SLE and basket
studies in renal and hematologic autoimmune diseases, with initial
clinical data from the basket studies expected in late 2023. (View
Release)
- At the American Society of Nephrology: Kidney Week Meeting,
updated clinical data were presented in a poster titled, “Phase 1
Study in Healthy Adults of the Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Dual
BAFF/APRIL Antagonist for the Treatment of Autoimmune
Glomerulonephritides (GN)”. (View Release)
- The data demonstrate that ALPN-303 continues to be well
tolerated as single intravenous or subcutaneous doses of up to 960
mg and exhibits dose-related pharmacokinetic and on-target
pharmacodynamic effects.
- ALPN-303 maintains target coverage of free APRIL for 2-3 and ≥4
weeks with 80 and 240 mg, respectively, corresponding to reductions
in serum Ig and antibody-secreting cells (CD38hi
plasmablasts/plasma cells).
- ALPN-303 dose-dependently reduces serum galactose-deficient
IgA1 (Gd-IgA1), a critical molecule implicated in the pathogenesis
of IgA nephropathy (IgAN).
- These data support dose regimens of 80-240 mg SC every 4 weeks
in future GN studies.
- The Company also presented clinical data from the RUBY-1 study
of healthy vs at the recent American College of Rheumatology in a
poster titled, “A Randomized Placebo-Controlled Phase 1 Study in
Healthy Adult Volunteers of the Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual
BAFF/APRIL Antagonist for the Treatment of Systemic Lupus
Erythematosus and Other Autoantibody-Associated Diseases”. (View
Poster)
- Additional updates will be presented at the American Society of
Hematology Conference in December. (View Release)
Corporate
- The Company ended the third quarter with $277.1 million in
cash, cash equivalents, restricted cash, and investments, following
the successful completion of a $100.0 million underwritten public
offering where we sold 13.6 million shares of our common stock with
net proceeds of approximately $93.5 million, after deducting
underwriting commissions and estimated offering expenses.
- An additional 1.9 million shares of our common stock were sold
pursuant to the underwriters’ partial exercise of their
over-allotment option, with net proceeds of $13.1 million received
upon closing on October 4, 2022.
- The financing brings our pro-forma cash and investments balance
to $290.2 million as of September 30, 2022, which should be
sufficient to fund our planned operations through 2025.
- On October 24, the Company announced that it had voluntarily
terminated enrollment in the NEON studies of davoceticept as a
monotherapy and in combination with pembrolizumab. (View
Release)
Third Quarter 2022 Financial
Results
As of September 30, 2022, Alpine’s cash, cash equivalents,
restricted cash, and investments totaled $277.1 million. The
Company recorded net losses of $13.3 million and $13.5 million for
the quarters ended September 30, 2022, and 2021, respectively.
Collaboration revenue for the third quarter ended September 30,
2022, was $8.4 million compared to $8.5 million for the third
quarter ended September 30, 2021. The 2022 amounts were primarily
attributable to revenue recognized under the Company’s AbbVie and
Horizon collaborations, while 2021 revenue recognized solely
related to the AbbVie collaboration.
Research and development expenses for the third quarter ended
September 30, 2022, were $17.6 million compared to $18.3 million
for the third quarter ended September 30, 2021. The decrease was
primarily attributable to decreased clinical development activities
offset by higher personnel-related expenses due to increased
headcount.
General and administrative expenses for the third quarter ended
September 30, 2022, were $4.6 million compared to $3.5 million for
the third quarter ended September 30, 2021. The increase was
primarily attributable to increases in personnel costs.
About ALPN-303 and the RUBY-1 Study
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.
Based upon an engineered TACI (transmembrane activator and CAML
interactor) domain, ALPN-303 exhibits greater potency in
preclinical studies versus wild-type TACI-based comparators, as
well as other inhibitors of BAFF and/or APRIL alone. ALPN-303 is in
development for multiple B cell and/or autoantibody-related
diseases, such as systemic lupus erythematosus,
glomerulonephritides, and autoimmune cytopenias.
RUBY-1 (NCT05034484) is a phase 1, randomized,
placebo-controlled study in healthy adult volunteers designed to
evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of single doses of intravenously and
subcutaneously administered ALPN-303. Initial data show ALPN-303 to
be well tolerated up to 960 mg with dose-dependent pharmacokinetics
and reductions in circulating immunoglobulins and
antibody-secreting cells, supporting the use of a once every
four-week dose regimen for subsequent studies.
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 potential
efficacy, safety profile, future development plans, addressable
market, regulatory success, and commercial potential of our product
candidates; and the timing of our public presentations and
potential publication of future clinical data. 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.
“NEON-1,” “NEON-2,” "Synergy," and the Alpine logo are
registered trademarks or trademarks of Alpine Immune Sciences, Inc.
in various jurisdictions.
ALPN-202, NEON-2 study in collaboration with Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA
Alpine Immune Sciences, Inc.
Selected Consolidated Balance Sheet
Data
(In thousands)
September 30, 2022
December 31, 2021
(unaudited)
Cash and cash equivalents
$
126,625
$
67,907
Short-term investments
122,237
94,396
Total current assets
253,239
192,013
Long-term investments
28,016
52,866
Total assets
291,599
255,900
Total current liabilities
68,459
69,778
Total stockholders’ equity
182,009
120,903
Total liabilities and stockholders’
equity
291,599
255,900
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,
2022
2021
2022
2021
(unaudited)
Collaboration revenue
$
8,367
$
8,516
$
27,288
$
18,913
Operating expenses:
Research and development
17,589
18,309
51,487
43,380
General and administrative
4,610
3,470
13,579
10,016
Total operating expenses
22,199
21,779
65,066
53,396
Loss from operations
(13,832
)
(13,263
)
(37,778
)
(34,483
)
Other income (expense):
Interest expense
(105
)
(203
)
(389
)
(638
)
Interest income
664
52
1,123
166
Other expense
—
—
(72
)
—
Loss before taxes
(13,273
)
(13,414
)
(37,116
)
(34,955
)
Income tax expense
—
(80
)
(1,782
)
(211
)
Net loss
$
(13,273
)
$
(13,494
)
$
(38,898
)
$
(35,166
)
Comprehensive income (loss):
Unrealized loss on investments
(307
)
(17
)
(1,385
)
(1
)
Unrealized gain (loss) on foreign currency
translation
7
(13
)
(11
)
(37
)
Comprehensive loss
$
(13,573
)
$
(13,524
)
$
(40,294
)
$
(35,204
)
Weighted-average shares used to compute
basic and diluted net loss per share
31,574,358
24,724,442
31,559,886
24,169,993
Basic and diluted net loss per share
$
(0.42
)
$
(0.55
)
$
(1.23
)
$
(1.45
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221114006012/en/
Temre Johnson (Investors) Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com
Kelli Perkins (Media) Red House kelli@redhousecomms.com
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