Alpine Immune Sciences Reports Second Quarter 2023 Financial Results
- None.
- None.
--The Company will present preliminary data from RUBY-3 glomerulonephritis clinical study at the American Society of Nephrology Meeting in November 2023--
“During the first half of 2023 we achieved several important milestones in the development of povetacicept, our potentially best-in-class dual BAFF/APRIL inhibitor being advanced in multiple autoimmune diseases. We are pleased to have initiated patient enrollment in the RUBY-4 study of povetacicept in autoimmune cytopenias and continue to be particularly encouraged by the high level of interest in the RUBY-3 study of povetacicept in autoimmune glomerulonephritis,” said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. “We look forward to sharing initial data later this year while we continue to plan for a broad and accelerated development program for povetacicept across multiple indications in 2024.”
Second Quarter 2023 Highlights & Recent Updates
- Initiated and continue to enroll patients in RUBY-4, a phase 1b, open-label study of povetacicept in autoimmune cytopenias, including immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease.
- Continue to enroll patients in RUBY-3, a phase 1b/2a, open-label study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
- Povetacicept continues to be administered subcutaneously via a convenient once every four-week dosing regimen.
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Preliminary clinical data from RUBY-3 will be presented at the American Society of Nephrology (ASN) Annual Kidney Week Meeting, November 2-5, 2023, in
Philadelphia, PA.
Second Quarter 2023 Financial Results
Cash Position and Runway: As of June 30, 2023, Alpine’s cash and investments totaled
Collaboration Revenue: For the three and six months ended June 30, 2023, collaboration revenue was
Research and Development Expenses: For the three and six months ended June 30, 2023, research and development expenses, inclusive of non-cash expenses, were
General and Administrative Expenses: For the three and six months ended June 30, 2023, general and administrative expenses, inclusive of non-cash expenses, were
Net Loss: Net loss for the three and six months ended June 30, 2023, was
Alpine Immune Sciences, Inc. |
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Selected Condensed Consolidated Balance Sheet Data |
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(In thousands) |
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June 30, 2023 |
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December 31, 2022 |
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(unaudited) |
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Cash and cash equivalents |
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$ |
34,076 |
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$ |
13,376 |
Short-term investments |
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169,724 |
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|
224,265 |
Total current assets |
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207,321 |
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240,993 |
Long-term investments |
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35,561 |
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|
35,481 |
Total assets |
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252,836 |
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286,686 |
Total current liabilities |
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53,410 |
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57,996 |
Total stockholders’ equity |
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169,388 |
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179,420 |
Total liabilities and stockholders’ equity |
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252,836 |
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286,686 |
Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) Data |
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(In thousands, except share and per share amounts) |
Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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(unaudited) |
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Collaboration revenue |
$ |
8,593 |
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$ |
5,292 |
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$ |
17,980 |
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$ |
18,921 |
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Operating expenses: |
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Research and development |
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19,241 |
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17,587 |
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38,822 |
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33,898 |
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General and administrative |
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5,007 |
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4,194 |
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10,405 |
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8,969 |
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Total operating expenses |
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24,248 |
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21,781 |
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49,227 |
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42,867 |
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Loss from operations |
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(15,655 |
) |
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(16,489 |
) |
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(31,247 |
) |
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(23,946 |
) |
Other income (expense): |
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Interest income |
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2,528 |
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314 |
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4,946 |
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459 |
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Interest expense |
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(28 |
) |
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(130 |
) |
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(98 |
) |
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(284 |
) |
Other, net |
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(1 |
) |
|
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(15 |
) |
|
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(23 |
) |
|
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(72 |
) |
Loss before taxes |
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(13,156 |
) |
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(16,320 |
) |
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(26,422 |
) |
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(23,843 |
) |
Income tax expense |
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— |
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(1,778 |
) |
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— |
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(1,782 |
) |
Net loss |
$ |
(13,156 |
) |
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$ |
(18,098 |
) |
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$ |
(26,422 |
) |
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$ |
(25,625 |
) |
Comprehensive income (loss): |
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Unrealized (loss) gain on investments |
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(238 |
) |
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(304 |
) |
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507 |
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(1,078 |
) |
Unrealized loss on foreign currency translation |
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(5 |
) |
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(4 |
) |
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(36 |
) |
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(18 |
) |
Comprehensive loss |
$ |
(13,399 |
) |
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$ |
(18,406 |
) |
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$ |
(25,951 |
) |
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$ |
(26,721 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
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48,049,936 |
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30,324,933 |
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47,810,374 |
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30,311,527 |
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Basic and diluted net loss per share |
$ |
(0.27 |
) |
|
$ |
(0.60 |
) |
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$ |
(0.55 |
) |
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$ |
(0.85 |
) |
Povetacicept (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 pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, particularly antibody-secreting cells, as well as T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus wild-type TACI-based comparators, as well as other inhibitors of BAFF and/or APRIL alone. Povetacicept is in development for multiple autoimmune diseases, such as systemic lupus erythematosus, autoimmune glomerulonephritis, and autoimmune cytopenias.
About RUBY-3
RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in IgA nephropathy, lupus nephritis, and primary membranous nephropathy, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include proteinuria, eGFR, renal response, and disease-related autoantibodies.
About RUBY-4
RUBY-4 (NCT05757570) is a multi-cohort, open label, phase 1b study of povetacicept in immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include respective blood cell counts, including durable responses, as well as disease-related autoantibodies.
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 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, cash equivalents, restricted cash, and investments to fund our planned operations through 2025; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our ongoing development programs; the timing of our public presentations and potential publication of future clinical data; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding our ongoing collaborations; 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 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 pandemics, or other related health crises 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; 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.
The RUBY and Alpine logos are registered trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814825100/en/
Investor and Media Contact:
Temre Johnson
Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com
media@alpineimmunesciences.com
Source: Alpine Immune Sciences, Inc.
FAQ
What are the financial results for Alpine Immune Sciences for Q2 2023?
What studies is Alpine Immune Sciences currently conducting?
When will preliminary data from the RUBY-3 study be presented?
