Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results
-- Clinical data on povetacicept in IgA nephropathy will be updated at the upcoming WCN meeting, including follow up at 80 mg and initial data at 240 mg SC once every four-weeks --
-- Povetacicept advancing towards a pivotal phase 3 trial in IgA nephropathy and a phase 2 trial in systemic lupus erythematosus --
“2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the
Fourth Quarter 2023 Corporate Updates
Povetacicept (ALPN-303)
-
First clinical data in IgAN demonstrate that povetacicept 80 mg administered once every four-weeks (Q4W) reduced proteinuria (as assessed by urine protein to creatinine ratio, UPCR) by greater than 50% and was associated with stable renal function (as assessed by estimated glomerular filtration rate, eGFR) at six months. In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG < 3 g/L, and no severe infections (2023
American Society of Nephrology Kidney Week ). -
In a model of murine experimental autoimmune myasthenia gravis, povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody (2023
American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting). -
New translational data from povetacicept in systemic lupus erythematosus demonstrate that povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulates genes associated with activation in B cells and significantly reduces multiple disease parameters in a mouse model of lupus, more effectively than WT TACI-Fc or conventional B cell depletion (2023
American College of Rheumatology Convergence ). -
Throughout 2023, the Company presented multiple oral and poster presentations on povetacicept at scientific conferences (Full List of
Company Publications and Presentations).
Corporate Updates
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The Company plans to present additional data on povetacicept in IgA nephropathy, including follow up data from the 80 mg Q4W and initial data from the IgAN 240 mg Q4W dose cohorts, during a Late Breaking Abstract session at the
World Congress of Nephrology 2024 onMonday April 15 th at4:45 PM ET . - The Company plans to present new preclinical data on povetacicept, demonstrating its greater distribution to disease-related end organs compared with WT TACI-Ig, at the 14th European Lupus Meeting. These findings correlate with povetacicept’s improved efficacy in multiple preclinical disease models.
- The Company intends to initiate RAINIER, a pivotal phase 3 study of povetacicept in IgA nephropathy and DENALI, a phase 2 study of povetacicept in systemic lupus erythematosus in the second half of 2024, pending regulatory agreement.
- The Company plans to share initial data from RUBY-4 in autoimmune cytopenias in the first half of 2024 at a relevant scientific congress.
- The Company amended its option and license agreement on acazicolcept with AbbVie, stopping enrollment in the phase 2 study in systemic lupus erythematosus (Synergy), and facilitating early assessment of data.
-
The Company ended the year with
$368.2 million in cash and investments as ofDecember 31, 2023 , which the Company anticipates should be sufficient to fund its planned operations into 2026.
2023 Financial Results
Cash Position and Runway: As of
Collaboration Revenue: For the year ended
Research and Development Expense: For the year ended
General and Administrative Expenses: For the year ended
Net Loss: Net loss for the year ended
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Selected Consolidated Balance Sheet Data |
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(In thousands) |
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||
|
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(unaudited) |
||||
Cash and cash equivalents |
|
$ |
43,921 |
|
$ |
13,376 |
Short-term investments |
|
|
283,491 |
|
|
224,265 |
Total current assets |
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|
330,034 |
|
|
240,993 |
Long-term investments |
|
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40,556 |
|
|
35,481 |
Total assets |
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379,852 |
|
|
286,686 |
Total current liabilities |
|
|
41,980 |
|
|
57,996 |
Total stockholders’ equity |
|
|
327,941 |
|
|
179,420 |
Total liabilities and stockholders’ equity |
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|
379,852 |
|
|
286,686 |
Consolidated Statement of Operations and Comprehensive Income (Loss) Data |
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(In thousands, except share and per share amounts) |
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Years Ended |
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2023 |
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2022 |
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(unaudited) |
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Collaboration revenue |
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$ |
58,876 |
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$ |
30,064 |
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Operating expenses: |
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Research and development |
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80,904 |
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|
|
70,243 |
|
General and administrative |
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22,222 |
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|
|
17,968 |
|
Total operating expenses |
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103,126 |
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88,211 |
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Loss from operations |
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(44,250 |
) |
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(58,147 |
) |
Other income (expense): |
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Interest income |
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11,852 |
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|
|
3,288 |
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Interest expense |
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(98 |
) |
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|
(476 |
) |
Other, net |
|
|
415 |
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|
|
(97 |
) |
Loss before taxes |
|
|
(32,081 |
) |
|
|
(55,432 |
) |
Income tax (expense) benefit |
|
|
(103 |
) |
|
|
(2,330 |
) |
Net loss |
|
$ |
(32,184 |
) |
|
$ |
(57,762 |
) |
Comprehensive income (loss): |
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Unrealized gain (loss) on investments |
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1,493 |
|
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(901 |
) |
Unrealized gain (loss) on foreign currency translation |
|
|
25 |
|
|
|
53 |
|
Comprehensive loss |
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$ |
(30,666 |
) |
|
$ |
(58,610 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
|
|
50,000,339 |
|
|
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33,435,280 |
|
Basic and diluted net loss per share |
|
$ |
(0.64 |
) |
|
$ |
(1.73 |
) |
About Povetacicept (ALPN-303)
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 other inhibitors of BAFF and/or APRIL alone and B cell depletion. Povetacicept is in development for multiple autoimmune diseases, including IgA nephropathy and other autoimmune kidney diseases, systemic lupus erythematosus, 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 autoimmune glomerulonephritis, including IgA nephropathy, primary membranous nephropathy, lupus nephritis, and renal ANCA-associated vasculitis, where povetacicept is being administered subcutaneously for up to 104 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
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, including cash equivalents and restricted cash, and investments to fund our planned operations into 2026; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our development programs; future development plans and clinical and regulatory milestones and objectives, including the timing and achievement thereof; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding the anticipated reporting of data from our ongoing and planned clinical trials and potential publication of future clinical data; our ability to potentially advance povetacicept directly into a pivotal trial in the second half of 2024 as well as a phase 2 study in systemic lupus erythematosus, pending engagement with and approval of the
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Investor and Media Contact:
ir@alpineimmunesciences.com
media@alpineimmunesciences.com
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