On May 11, 2023 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2023 (Press release, Alpine Immune Sciences, MAY 11, 2023, View Source [SID1234631481]).
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"So far this year, we have achieved important milestones in advancing clinical studies for povetacicept, our potential best-in-class dual BAFF/APRIL inhibitor being developed for multiple autoantibody-related diseases. The first participant was dosed in the RUBY-3 study of povetacicept in autoimmune glomerulonephritis and we are pleased with the high level of investigator interest in the study. We’ve also opened the RUBY-4 study of povetacicept in autoimmune cytopenias and are preparing to initiate enrollment this quarter," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "We remain on track to deliver preliminary data from both the RUBY-3 and RUBY-4 studies by the end of the year as we continue to pursue our mission of bringing meaningful new therapies to people living with autoimmune or inflammatory diseases."
First Quarter 2023 Highlights
Povetacicept (ALPN-303)
Initiated and continues to enroll participants in RUBY-3, a phase 1b, open-label basket study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
Advanced preparations for initiating enrollment in RUBY-4, a phase 1b, open-label basket study of povetacicept in autoimmune cytopenias, including immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease.
Presented encore phase 1 data from the RUBY-1 study of povetacicept in healthy adults in an ePoster and oral presentation at the American Academy of Dermatology Annual Meeting and in a poster session at the International Society of Nephrology World Congress of Nephrology.
Presented pharmacokinetic and pharmacodynamic modeling and simulation data to support clinical development of povetacicept in a poster session at the American Society for Clinical Pharmacology & Therapeutics Annual Meeting.
Plans to present an updated clinical dataset from the RUBY-1 study in healthy adult volunteers at the European Alliance of Associations for Rheumatology (EULAR) 2023 Congress in June.
First Quarter 2023 Financial Results
As of March 31, 2023, Alpine’s cash and investments totaled $248.3 million, which the Company anticipates is sufficient to fund its planned operations through 2025. The Company recorded net losses of $13.3 million and $7.5 million for the quarters ended March 31, 2023 and 2022, respectively.
Collaboration revenue for the first quarter ended March 31, 2023 was $9.4 million compared to $13.6 million for the first quarter ended March 31, 2022.
The decrease in collaboration revenue relates primarily to the Company’s agreement with Horizon. Horizon collaboration revenues for the three-months period ended March 31, 2023 decreased by $4.2 million related to services rendered in connection with the Company’s two ongoing research programs for Horizon, whereas the higher 2022 period revenues were the result of substantial completion of the initial existing program with Horizon.
Research and development expenses for the first quarter ended March 31, 2023 were $19.6 million compared to $16.3 million for the first quarter ended March 31, 2022. The increase was primarily attributable to higher personnel-related expenses due to increased headcount to support clinical trial activities.
General and administrative expenses for the first quarter ended March 31, 2023 were $5.4 million compared to $4.8 million for the first quarter ended March 31, 2022. The increase was primarily attributable to increases in personnel costs.
Alpine Immune Sciences, Inc.
Selected Consolidated Balance Sheet Data
(In thousands)
March 31,
2023
December 31,
2022
(unaudited)
Cash and cash equivalents
$14,465
$13,376
Short-term investments
180,460
224,265
Total current assets
198,784
240,993
Long-term investments
53,170
35,481
Total assets
262,100
286,686
Total current liabilities
57,089
57,996
Total stockholders’ equity
169,543
179,420
Total liabilities and stockholders’ equity
262,100
286,686
Consolidated Statement of Operations and Comprehensive Income (Loss) Data
(In thousands, except share and per share amounts)
Three Months Ended March 31,
2023
2022
(unaudited)
Collaboration revenue
$9,387
$13,629
Operating expenses:
Research and development
19,581
16,311
General and administrative
5,398
4,775
Total operating expenses
24,979
21,086
Loss from operations
(15,592)
(7,457)
Other income (expense):
Interest income
2,418
145
Interest expense
(70)
(154)
Other, net
(22)
(57)
Loss before taxes
(13,266)
(7,523)
Income tax benefit (expense)
—
(4)
Net loss
$(13,266)
$(7,527)
Comprehensive income (loss):
Unrealized gain (loss) on investments
745
(774)
Unrealized loss on foreign currency translation
(31)
(14)
Comprehensive loss
$(12,552)
$(8,315)
Weighted-average shares used to compute basic and diluted net loss per share
47,568,149
30,267,472
Basic and diluted net loss per share
$(0.28)
$(0.25)
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 the activation and survival of B cells, particularly antibody-secreting 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 B cell and/or autoantibody-related 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 study of povetacicept in IgA nephropathy, lupus nephritis, and primary membranous nephropathy, where povetacicept is being administered for up to 48 weeks in disease- and dose-specific cohorts. 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 for up to 48 weeks in disease-specific cohorts. Key endpoints include respective blood cell counts, including durable responses, as well as disease-related autoantibodies.