Alpine Immune Sciences Reports Second Quarter 2020 Financial Results and Provides Corporate Update
- Signed option to license worldwide rights to ALPN-101 with AbbVie -
- Received
- Dosed first patient in NEON-1 Phase 1 trial of ALPN-202 in patients with advanced malignancies -
- Raised
- Conference call and webcast today at
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 fromAvidity 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, inHealthy 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
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 endedJuly 31, 2020 with$147.5 million in cash, cash equivalents, restricted cash, and short-term investments. This compares to$36.1 million as ofMarch 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 endedJune 30, 2020 and 2019, respectively, and$15.5 million and$24.2 million for the six months endedJune 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 endedJune 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 endedJune 30, 2019 , and$5.1 million and$4.9 million for the six months endedJune 30, 2020 and 2019, respectively.
Cash Guidance
Taking the recent private placement into account, Alpine ended
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
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
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
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
“Secreted Immunomodulatory Proteins,” “SIP,” “Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and the Alpine logo are registered trademarks or trademarks of
|
|
|
|
|
||||
Selected Consolidated Balance Sheet Data |
|
|
|
|
||||
(In thousands) |
|
|
|
|
||||
|
|
|
|
|
||||
|
|
(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 |
|
Six Months Ended |
||||||||||||
|
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/
Contact:
Chief Financial Officer
206-788-4545
[email protected]
Managing Director
619-916-7620
[email protected]
Source: