Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results
- Positive clinical data on povetacicept in IgAN and SLE
- Plans for pivotal phase 3 trial in IgAN and phase 2 trial in SLE
- Significant increase in collaboration revenue
- Strong cash position to fund operations into 2026
- None.
Insights
Alpine Immune Sciences' reported financials reflect a strategic focus on advancing their lead candidate povetacicept, with a robust cash position to support operations into 2026. The increase in collaboration revenue by almost 96%, largely attributed to the amended agreement with AbbVie, is a positive indicator of the company's ability to monetize its research partnerships effectively. However, the reported net loss decrease from $57.8 million in 2022 to $32.2 million in 2023, while still significant, suggests improved cost management and potential operational efficiencies. The research and development expenses have increased, indicating ongoing investment in their pipeline, which is necessary for long-term growth but could pressure short-term financial performance. Investors should note the company's commitment to R&D as a sign of confidence in its pipeline's potential.
The clinical progression of povetacicept, particularly in IgA nephropathy (IgAN), is noteworthy. The reduction in proteinuria and stable renal function at six months suggest a promising therapeutic profile. The advancement into a pivotal phase 3 trial is a critical milestone that could significantly impact the company's valuation if successful. Moreover, the expansion into systemic lupus erythematosus (SLE) with a planned phase 2 trial indicates a strategic move to widen the drug's potential market. The translational data supporting its efficacy in multiple inflammatory diseases further underpins its best-in-class potential. The medical community will be watching closely for the upcoming data presentations, as these will offer deeper insights into povetacicept's efficacy and safety profile.
Alpine Immune Sciences' strategic amendments with AbbVie and the planned initiation of new clinical trials are indicative of a proactive approach to pipeline development and market positioning. The biotech sector places a premium on such innovative treatments for autoimmune and inflammatory diseases, which currently have high unmet medical needs. The company's focus on a next-generation dual BAFF/APRIL inhibitor may set them apart in a competitive landscape. The current cash runway into 2026 provides the company with a buffer to navigate the costly clinical trial phases without immediate fundraising pressures. This financial stability, coupled with potential clinical milestones, could make Alpine an interesting case for investors tracking the immunotherapy space.
-- 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 American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor. With our encouraging data set in IgAN, convenient once monthly dosing regimen, and strong balance sheet, we are rapidly advancing development of povetacicept as a potentially meaningful new therapeutic option for patients living with IgAN, systemic lupus erythematosus (SLE), and multiple other autoantibody-related diseases,” said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine.
Dr. Gold continued, “Looking ahead, Alpine is well positioned for a year of meaningful catalysts, with multiple updates for povetacicept in IgAN and other indications, and the planned initiation of RAINIER, a pivotal phase 3 study of povetacicept in IgAN, and DENALI, a phase 2 study of povetacicept in SLE. In addition to updates on our clinical studies, we look forward to sharing translational data that further supports the best-in-class potential of povetacicept in multiple inflammatory diseases.”
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
- 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 on Monday April 15th at 4:45 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
2023 Financial Results
Cash Position and Runway: As of December 31, 2023, Alpine’s cash and investments totaled
Collaboration Revenue: For the year ended December 31, 2023, collaboration revenue was
Research and Development Expense: For the year ended December 31, 2023, research and development expense, inclusive of non-cash expenses, were
General and Administrative Expenses: For the year ended December 31, 2023, general and administrative expenses, inclusive of non-cash expenses, were
Net Loss: Net loss for the year ended December 31, 2023, was
Alpine Immune Sciences, Inc. |
|
|
|
|
||
Selected Consolidated Balance Sheet Data |
|
|
|
|
||
(In thousands) |
|
December 31, 2023 |
|
December 31, 2022 |
||
|
|
(unaudited) |
||||
Cash and cash equivalents |
|
$ |
43,921 |
|
$ |
13,376 |
Short-term investments |
|
|
283,491 |
|
|
224,265 |
Total current assets |
|
|
330,034 |
|
|
240,993 |
Long-term investments |
|
|
40,556 |
|
|
35,481 |
Total assets |
|
|
379,852 |
|
|
286,686 |
Total current liabilities |
|
|
41,980 |
|
|
57,996 |
Total stockholders’ equity |
|
|
327,941 |
|
|
179,420 |
Total liabilities and stockholders’ equity |
|
|
379,852 |
|
|
286,686 |
Consolidated Statement of Operations and Comprehensive Income (Loss) Data |
|
|
|
|
||||
(In thousands, except share and per share amounts) |
|
Years Ended December 31, |
||||||
|
|
2023 |
|
2022 |
||||
|
|
(unaudited) |
||||||
Collaboration revenue |
|
$ |
58,876 |
|
|
$ |
30,064 |
|
Operating expenses: |
|
|
|
|
||||
Research and development |
|
|
80,904 |
|
|
|
70,243 |
|
General and administrative |
|
|
22,222 |
|
|
|
17,968 |
|
Total operating expenses |
|
|
103,126 |
|
|
|
88,211 |
|
Loss from operations |
|
|
(44,250 |
) |
|
|
(58,147 |
) |
Other income (expense): |
|
|
|
|
||||
Interest income |
|
|
11,852 |
|
|
|
3,288 |
|
Interest expense |
|
|
(98 |
) |
|
|
(476 |
) |
Other, net |
|
|
415 |
|
|
|
(97 |
) |
Loss before taxes |
|
|
(32,081 |
) |
|
|
(55,432 |
) |
Income tax (expense) benefit |
|
|
(103 |
) |
|
|
(2,330 |
) |
Net loss |
|
$ |
(32,184 |
) |
|
$ |
(57,762 |
) |
Comprehensive income (loss): |
|
|
|
|
||||
Unrealized gain (loss) on investments |
|
|
1,493 |
|
|
|
(901 |
) |
Unrealized gain (loss) on foreign currency translation |
|
|
25 |
|
|
|
53 |
|
Comprehensive loss |
|
$ |
(30,666 |
) |
|
$ |
(58,610 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
|
|
50,000,339 |
|
|
|
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 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 X 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, 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 Food and Drug Administration; and the potential efficacy, safety profile, addressable market, regulatory success and commercial or therapeutic potential of our product candidates. 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; we may be unable to advance povetacicept directly into a pivotal trial or a phase 2 study in systemic lupus erythematosus in the second half of 2024; 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/20240318513454/en/
Investor and Media Contact:
Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com
media@alpineimmunesciences.com
Source: Alpine Immune Sciences, Inc.
FAQ
What clinical data was reported on povetacicept in IgA nephropathy?
What upcoming trials are planned for povetacicept?
How did Alpine's collaboration revenue change in 2023 compared to 2022?
What is Alpine's cash position as of December 31, 2023?
How long does Alpine anticipate its current cash and investments to fund operations?
