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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Alpine Immune Sciences Inc | NASDAQ:ALPN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.02 | 0.03% | 64.97 | 64.92 | 64.99 | 64.97 | 64.94 | 64.95 | 1,260,502 | 22:17:20 |
- 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
“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
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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