Alpine Immune Sciences Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results
Alpine Immune Sciences (NASDAQ: ALPN) reported a transformative year in 2020, focusing on innovative therapies for cancer and autoimmune diseases. They plan to initiate an international Phase 2 trial for ALPN-101 in systemic lupus erythematosus and continue their Phase 1 study for ALPN-202. The company raised $60 million from a private placement and formed an exclusive license agreement with AbbVie for ALPN-101, potentially worth $805 million. Financially, they reported $131.4 million in cash and a rise in collaboration revenue to $9.3 million, while net losses decreased from $41.9 million in 2019 to $27.9 million in 2020.
- Cash and investments totaled $131.4 million as of December 31, 2020.
- Collaboration revenue increased to $9.3 million from $1.7 million in 2019, mainly due to the AbbVie Agreement.
- Reduction in net losses from $41.9 million in 2019 to $27.9 million in 2020.
- Plans to initiate a Phase 2 trial for ALPN-101 and further progress ALPN-202 and ALPN-303.
- Net cash used in operating activities was $35.3 million in 2019, indicating prior cash burn concerns.
- General and administrative expenses increased to $10.9 million in 2020 from $9.5 million in 2019, impacting profitability.
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 fourth quarter and year ended December 31, 2020.
“This past year has been transformative for the company. We are building on our strong momentum to accelerate development of innovative therapies for patients living with cancer and autoimmune/inflammatory disease,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “Over the next year we will continue to execute on our clinical-stage programs and plan to initiate an international Phase 2 trial of ALPN-101 in adults with systemic lupus erythematosus (SLE), and further progress our ongoing NEON-1 Phase 1 study of ALPN-202 in advanced malignancies. We also plan to progress key pipeline programs, including the initiation of a Phase 1 healthy volunteer study for ALPN-303. In summary, I believe 2021 will be another year of significant opportunity for Alpine as we advance our pipeline of innovative therapeutic candidates.”
Full Year 2020 and Recent Corporate and Clinical Updates
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ALPN-101: Dual CD28/ICOS inhibitor
-
Announced Option and License Agreement with AbbVie: In June 2020, Alpine announced an exclusive worldwide option and license agreement for ALPN-101. 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, including up to$75 million in pre-option development milestones. In addition, Alpine is eligible to receive tiered royalties on net sales of ALPN-101. - Preparation for a global Phase 2 study in SLE is ongoing with an intent to initiate the study in mid-2021.
-
Announced Option and License Agreement with AbbVie: In June 2020, Alpine announced an exclusive worldwide option and license agreement for ALPN-101. Under the terms of the agreement, Alpine received an upfront payment of
-
ALPN-202: Conditional CD28 costimulator and dual checkpoint inhibitor
- Presentation of NEON-1 trial design at the American Association of Cancer Research (AACR) Virtual Annual Meeting 2020: The design of NEON-1, our first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, was presented at the AACR Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.
- Enrollment in NEON-1, a first in human monotherapy Phase 1 clinical trial, continues to progress through its dose escalation cohorts. Alpine plans to share interim data at an appropriate scientific forum and to determine expansion cohorts later this year.
- Alpine is also targeting the initiation of NEON-2, a Phase 1 combination study of ALPN-202 and a PD-1 inhibitor, later this year.
-
ALPN-303: Dual APRIL/BAFF inhibitor
- Presentation of Preclinical Data on Novel B cell Modulatory Domains, Alone or in Combination with Novel Domains that Inhibit T Cell Costimulation, for Autoimmune Diseases: In June 2020, Alpine presented a poster at the European Congress of Rheumatology (EULAR) E-Congress detailing preclinical work with novel B cell modulatory variant TNF Receptor domains (vTDs), alone or in combination with variant Ig Domains (vIgDtm) that inhibit T cell costimulation. This work included ALPN-303, a novel dual BAFF/APRIL inhibitor, in multiple preclinical models, including the NZB/NZW F1 murine lupus model.
- Alpine is targeting completion of activities to support initiation of a Phase 1 healthy volunteer study with ALPN-303 in the fourth quarter of this year.
-
General Corporate
-
Raised
$60 Million in a Private Placement: In July 2020, 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. - Appointed industry veteran Natasha Hernday to the Board of Directors: Ms. Hernday brings more than 20 years of experience in corporate development and corporate strategy, and currently serves as Executive Vice President, Corporate Development and as a member of the Executive Committee for Seagen, Inc.
- Promotion of Remy Durand, Ph.D. to Chief Business Officer: Dr. Durand joined Alpine Immune Sciences in 2018 as Vice President, Business Development, and has played a leading role in building the company’s partnerships with AbbVie and Adaptimmune, and has represented the company at investor meetings and conferences.
- Appointed Pamela Holland, Ph.D. as Senior Vice President, Research: Dr. Holland is an experienced cancer biologist with a proven track record of successfully discovering and progressing multiple preclinical therapeutics into clinical development, most recently at Surface Oncology and Amgen.
-
Raised
Full Year 2020 Financial Results
As of December 31, 2020, we had cash, cash equivalents, and investments totaling
Collaboration revenue for the year ended December 31, 2020 was
Research and development expenses for the year ended December 31, 2020 were
General and administrative expenses for the year ended December 31, 2020 were
Alpine expects that its current cash resources, combined with the potential
Fourth Quarter and Full Year 2020 Conference Call and Webcast Details
Alpine will host a conference call and live webcast to discuss the fourth quarter and full year performance today, March 18, 2021 at 4:30 p.m. ET/1:30 p.m. PT.
To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 2539338. A live webcast of the presentation will be available online in the investor relations section of the company’s website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. 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 combined with the potential
“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. |
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Selected Consolidated Balance Sheet Data |
||||||||
(In thousands) |
||||||||
|
|
December 31,
|
|
December 31,
|
||||
Cash and cash equivalents |
|
$ |
34,959 |
|
|
$ |
16,123 |
|
Short-term investments |
|
70,622 |
|
|
24,397 |
|
||
Total current assets |
|
107,101 |
|
|
42,302 |
|
||
Long-term investments |
|
25,549 |
|
|
— |
|
||
Total assets |
|
144,090 |
|
|
54,093 |
|
||
Total current liabilities |
|
41,167 |
|
|
8,681 |
|
||
Total stockholders’ equity |
|
62,158 |
|
|
29,474 |
|
||
Total liabilities and stockholders’ equity |
|
144,090 |
|
|
54,093 |
|
||
Consolidated Statement of Operations and
|
||||||||||||||||||||
(In thousands, except share and per share amounts) |
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|||||||||||||||||
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|||||||||
|
(unaudited) |
|||||||||||||||||||
Collaboration revenue |
$ |
5,643 |
|
|
|
$ |
884 |
|
|
|
$ |
9,335 |
|
|
|
$ |
1,740 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||||||
Research and development |
9,055 |
|
|
|
5,799 |
|
|
|
27,185 |
|
|
|
35,847 |
|
|
|||||
General and administrative |
3,049 |
|
|
|
2,102 |
|
|
|
10,899 |
|
|
|
9,467 |
|
|
|||||
Total operating expenses |
12,104 |
|
|
|
7,901 |
|
|
|
38,084 |
|
|
|
45,314 |
|
|
|||||
Loss from operations |
(6,461 |
) |
|
|
(7,017 |
) |
|
|
(28,749 |
) |
|
|
(43,574 |
) |
|
|||||
Other income (expense): |
|
|
|
|
|
|
|
|||||||||||||
Interest expense |
(215 |
) |
|
|
(141 |
) |
|
|
(775 |
) |
|
|
(338 |
) |
|
|||||
Interest income |
291 |
|
|
|
206 |
|
|
|
245 |
|
|
|
1,248 |
|
|
|||||
Other income |
43 |
|
|
|
812 |
|
|
|
1,333 |
|
|
|
812 |
|
|
|||||
Loss before taxes |
(6,342 |
) |
|
|
(6,140 |
) |
|
|
(27,946 |
) |
|
|
(41,852 |
) |
|
|||||
Income tax benefit |
— |
|
|
|
— |
|
|
|
6 |
|
|
|
— |
|
|
|||||
Net loss |
$ |
(6,342 |
) |
|
|
$ |
(6,140 |
) |
|
|
$ |
(27,940 |
) |
|
|
$ |
(41,852 |
) |
|
|
Comprehensive income (loss): |
|
|
|
|
|
|
|
|||||||||||||
Unrealized gain (loss) on investments |
1 |
|
|
|
(8 |
) |
|
|
(15 |
) |
|
|
29 |
|
|
|||||
Unrealized gain (loss) on foreign currency translation |
93 |
|
|
|
11 |
|
|
|
58 |
|
|
|
(6 |
) |
|
|||||
Comprehensive loss |
$ |
(6,248 |
) |
|
|
$ |
(6,137 |
) |
|
|
$ |
(27,897 |
) |
|
|
$ |
(41,829 |
) |
|
|
Weighted-average shares used to compute basic and diluted net loss per share |
23,803,183 |
|
|
|
18,587,817 |
|
|
|
20,826,466 |
|
|
|
18,358,864 |
|
|
|||||
Basic and diluted net loss per share |
$ |
(0.27 |
) |
|
|
$ |
(0.33 |
) |
|
|
$ |
(1.34 |
) |
|
|
$ |
(2.28 |
) |
|
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FAQ
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