- Signed option to license worldwide rights to
ALPN-101 with AbbVie -
- Received $60 million upfront cash payment
from AbbVie; eligible to receive up to $805 million for exercise of
the option and success-based development, regulatory and commercial
milestones -
- Dosed first patient in NEON-1 Phase 1 trial
of ALPN-202 in patients with advanced malignancies -
- Raised $60 million in July private placement
led by Omega Funds -
- Conference call and webcast today at 4:30
p.m. ET -
Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for cancer and autoimmune/inflammatory
diseases, today provided a corporate update and reported financial
results for the second quarter ended June 30, 2020.
Key Second Quarter 2020 and Subsequent Highlights
- Announced ALPN-101 Option and License Agreement with AbbVie
for up to $865 million plus royalties on future sales. In June,
Alpine and AbbVie announced an exclusive worldwide option and
license agreement for ALPN-101, a first-in-class dual CD28/ICOS
costimulation antagonist. Under the terms of the agreement, Alpine
received an upfront payment of $60 million and is eligible to
receive up to an aggregate of $805 million for exercise of the
option and success-based development, regulatory, and commercial
milestones. In addition, Alpine is eligible to receive tiered
royalties on net sales of ALPN-101. In exchange, AbbVie received an
exclusive option to an exclusive license for ALPN-101.
- Initiated the first-in-human, Phase 1 Trial of ALPN-202.
In June, Alpine announced the first patient had been successfully
dosed in its NEON-1 Phase 1 study of ALPN-202, a first-in-class
conditional CD28 costimulator and dual checkpoint inhibitor, in
advanced malignancies.
- Raised $60 Million in a Private Placement. In July,
Alpine raised $60 million in gross proceeds through a private
placement led by Omega Funds with participation from Avidity
Partners, EcoR1 Capital, LLC, Invus Public Equities, L.P., and
Samsara BioCapital, among others. Alpine intends to use the net
proceeds to fund the development of its clinical and preclinical
pipeline as well as for general corporate purposes.
- Presented at Multiple Scientific Meetings. From April to
June, Alpine made a number of presentations at important scientific
conferences including:
- ALPN-202 Study Design Presented at AACR I - “NEON-1: A
first-in-human phase I open-label study of ALPN-202, a conditional
CD28 costimulator and dual checkpoint inhibitor, in advanced
malignancies.”
- ALPN-202 Additional Preclinical Data at AACR II -
“ALPN-202 combines checkpoint inhibition with conditional T cell
costimulation to overcome T cell suppression by M2c macrophages and
improve the durability of engineered T cell anti-tumor
responses.”
- Novel Dual BAFF/APRIL Inhibitory Domains (ALPN-303) for B
cell Mediated Autoimmune Diseases at EULAR 2020 - “B Cell
Modulatory Variant TNF Receptor Domains (vTDs) Identified by
Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined
with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation,
for the Treatment of Severe Autoimmune and/or Inflammatory
Disease.”
- ALPN-101 Phase 1 Trial Data at EULAR 2020 - “A Double
Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple
Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual
ICOS/CD28 Antagonist, in Healthy Volunteers (HV).”
“The highlight of Alpine’s second quarter was the signing of a
transformative option and license agreement for ALPN-101 with
AbbVie. This highly competitive deal provides validation of our
scientific approach and our unique Directed Evolution platform,”
said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive
Officer of Alpine. “Importantly, the progression of ALPN-101 is now
supported by our AbbVie partnership. Our platform has yielded
multiple product candidates in addition to ALPN-101. First among
these is ALPN-202, for which we dosed the first patient in our
NEON-1 Phase 1 study during the quarter. In addition, we were able
to further strengthen our balance sheet via a $60 million private
financing, adding a number of high-quality institutions to our
shareholder roster. I am very proud of all we have achieved of late
and I look forward to further updating you on our progress.”
Financial Highlights
- As of June 30, 2020, Alpine had cash, cash equivalents,
restricted cash, and short-term investments totaling $90.5 million.
This balance includes the $60 million upfront cash payment from
AbbVie for the option to license ALPN-101, but does not include the
$60 million of gross proceeds from our July private placement.
Taking the recent private placement into account, we ended July 31,
2020 with $147.5 million in cash, cash equivalents, restricted
cash, and short-term investments. This compares to $36.1 million as
of March 31, 2020.
- Net cash provided by operating activities for the six months
ended June 30, 2020 was $44.8 million compared to $19.1 million in
net cash used for the same period in 2019.
- Alpine recorded a net loss of $9.9 million and $11.9 million
for the second quarters ended June 30, 2020 and 2019, respectively,
and $15.5 million and $24.2 million for the six months ended June
30, 2020 and 2019, respectively.
- Research and development expenses for the second quarter ended
June 30, 2020 were $7.1 million compared to $10.2 million for the
second quarter ended June 30, 2019. For the first six months of
2020 they were $12.0 million compared to $20.5 million for the same
period in 2019.
- General and administrative expenses for the second quarter
ended June 30, 2020 were $3.3 million compared to $2.6 million for
the second quarter ended June 30, 2019, and $5.1 million and $4.9
million for the six months ended June 30, 2020 and 2019,
respectively.
Cash Guidance
Taking the recent private placement into account, Alpine ended
July 31, 2020 with $147.5 million in cash, cash equivalents,
restricted cash, and short-term investments. Alpine expects that
its current cash resources, combined with the potential $75 million
in pre-option exercise milestones payable under its option and
license agreement with AbbVie, for the development and
commercialization of ALPN-101, are sufficient to fund Alpine's
planned operations through 2024, including a planned Phase 2 study
of ALPN-101 in systemic lupus erythematosus and the further
development of ALPN-202 and ALPN-303.
For additional information regarding Alpine’s planned
operations, please refer to “Item 2. Management’s Discussion and
Analysis of Financial Condition and Results of Operation -
Liquidity and Capital Resources” in Alpine’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2020, which Alpine
anticipates filing with the Securities and Exchange Commission on
or about August 11, 2020.
Conference Call
Individuals interested in listening to the conference call may
do so by dialing (800) 816-3005 for domestic callers, or (857)
770-0069 for international callers, and using the conference ID:
1699961; or from the webcast link in the investor relations section
of the company’s website at: www.alpineimmunesciences.com. The
recorded webcast will be available for replay for approximately 30
days following the call.
About ALPN-101
ALPN-101 is a novel Fc fusion protein of a human inducible T
cell costimulatory ligand (ICOSL) variant immunoglobulin domain
(vIgD™), a first-in-class therapeutic designed to inhibit
simultaneously the CD28 and ICOS inflammation pathways. CD28 and
ICOS are closely related costimulatory molecules with partially
overlapping roles in T cell activation likely playing a role in
multiple autoimmune and inflammatory diseases. In June 2020, Alpine
and AbbVie signed an option and license agreement for the
development and commercialization of ALPN-101. During the option
period, Alpine will conduct a phase 2 study in systemic lupus
erythematosus. Upon exercise of the option, AbbVie will conduct all
future clinical development, manufacturing, and commercialization
activities for ALPN-101.
About ALPN-202
ALPN-202 is a first-in-class, conditional CD28 costimulator and
dual checkpoint inhibitor with the potential to improve upon the
efficacy of combined checkpoint inhibition while limiting
significant toxicities. Preclinical studies of ALPN-202 have
successfully demonstrated superior efficacy in tumor models
compared to checkpoint inhibition alone. A phase 1 trial of
ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is
currently enrolling.
About ALPN-303
ALPN-303 is a dual BAFF/APRIL B cell cytokine antagonist under
development for the treatment of B cell-mediated inflammatory
diseases. BAFF and APRIL are clinically validated targets, and in
preclinical studies, ALPN-303 appears to have superior activity
compared to other available inhibitors of these pathways,
suggesting the potential to be best-in-class. Development
activities to enable clinical trials have been initiated.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. is committed to leading a new wave
of immune therapeutics, creating potentially powerful
multifunctional immunotherapies to improve patients’ lives via
unique protein engineering technologies. Alpine is backed by
world-class research and development capabilities, a highly
productive scientific platform, and a proven management team. 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 pre-clinical development
activities, including those related to our collaboration with
AbbVie; clinical and regulatory objectives and the timing thereof;
expectations regarding the sufficiency of cash combined with the
potential $75 million in pre-option exercise milestones payable
under our option and license agreement with AbbVie to fund
operations through 2024; the potential efficacy, safety profile,
future development plans, addressable market, regulatory success,
and commercial potential of our product candidates, including those
related to our collaboration with AbbVie; our ability to achieve
milestones in our collaboration with AbbVie; the progress and
potential of our other ongoing development programs; the efficacy
of our clinical trial designs; expectations regarding our other
ongoing collaborations; the expected use of proceeds from the July
2020 private placement; the timing of our public presentations and
potential publication of future clinical data; 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 pre-clinical efforts may not yield additional product
candidates; our discovery-stage and pre-clinical programs may not
advance into the clinic or result in approved products; any of our
or our collaborators’ 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 expanded product development and clinical activities on
operating expenses; our assumptions regarding our planned
expenditures and sufficiency of cash to fund operations may be
incorrect; we may not achieve additional milestones pursuant to our
collaborations; the impact of competition; adverse conditions in
the general domestic and global economic markets, including as a
result of the ongoing COVID-19 pandemic; 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.
“Secreted Immunomodulatory Proteins,” “SIP,” “Transmembrane
Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and
the Alpine logo are registered trademarks or trademarks of Alpine
Immune Sciences, Inc. in various jurisdictions.
Alpine Immune Sciences, Inc.
Selected Consolidated Balance Sheet
Data
(In thousands)
June 30, 2020
December 31, 2019
(unaudited)
Cash and cash equivalents
$
88,220
$
16,123
Short-term investments
1,998
24,397
Total current assets
91,236
42,302
Total assets
102,695
54,093
Total current liabilities
28,179
8,681
Total stockholders’ equity
16,228
29,474
Total liabilities and stockholders’
equity
102,695
54,093
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,
2020
2019
2020
2019
(unaudited)
Collaboration revenue
$
688
$
567
$
1,779
$
567
Operating expenses:
Research and development
7,096
10,166
11,974
20,516
General and administrative
3,344
2,553
5,122
4,898
Total operating expenses
10,440
12,719
17,096
25,414
Loss from operations
(9,752
)
(12,152
)
(15,317
)
(24,847
)
Other income (expense):
Interest expense
(226
)
(61
)
(346
)
(131
)
Interest income
44
357
196
741
Loss before taxes
(9,934
)
(11,856
)
(15,467
)
(24,237
)
Income tax benefit
6
—
6
—
Net loss
$
(9,928
)
$
(11,856
)
$
(15,461
)
$
(24,237
)
Comprehensive income (loss):
Unrealized (loss) gain on investments
(1
)
17
(16
)
32
Unrealized gain (loss) on foreign currency
translation
64
4
(49
)
(10
)
Comprehensive loss
$
(9,865
)
$
(11,835
)
$
(15,526
)
$
(24,215
)
Weighted-average shares used to compute
basic and diluted net loss per share
18,588,993
18,576,199
18,588,442
18,126,556
Basic and diluted net loss per share
$
(0.53
)
$
(0.64
)
$
(0.83
)
$
(1.34
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200811005743/en/
Alpine Immune Sciences Inc.
Contact: Paul Rickey Chief Financial Officer
Alpine Immune Sciences, Inc. 206-788-4545
ir@alpineimmunesciences.com
Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 laurence@gilmartinir.com
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