CABAHIGH SIGNALOPERATIONAL10-K

CABA has strategically pivoted from a dual-platform approach to focus exclusively on its CARTA strategy while abandoning its legacy CAART approach entirely.

This represents a fundamental shift in the company's scientific strategy, concentrating all resources on CD19-CAR T cell therapy rather than pursuing two parallel B-cell targeting approaches. The pivot suggests management has gained clarity on their most promising therapeutic pathway, but also indicates the CAART approach may have encountered development challenges or shown inferior prospects.

Comparing 2026-03-23 vs 2025-03-31View on EDGAR →
FINANCIAL ANALYSIS

The company's financial position deteriorated meaningfully over the period, with operating cash outflows expanding substantially to $131.1M while cash reserves declined to $83.0M from $164.0M. R&D expenses grew notably to $142.7M, consistent with advancing clinical programs, though this acceleration combined with the strategic pivot raises questions about capital allocation efficiency. Current liabilities increased substantially to $50.2M, suggesting higher near-term obligations as the company advances its focused CARTA strategy.

FINANCIAL STATEMENT CHANGES
Current Liabilities
Balance Sheet
+85.2%
$27.1M$50.2M

Current liabilities surged 85.2% — significant near-term obligations; verify ability to meet short-term debt.

Total Liabilities
Balance Sheet
+62.1%
$32.7M$53.0M

Liabilities grew 62.1% — significant increase in debt or obligations, assess impact on financial flexibility.

Cash & Equivalents
Balance Sheet
-49.4%
$164.0M$83.0M

Cash declined 49.4% — significant cash burn or deployment; verify adequacy of remaining liquidity runway.

Operating Cash Flow
Cash Flow
-48.6%
-$88.2M-$131.1M

Operating cash flow fell 48.6% — earnings quality concerns; investigate working capital changes and non-cash items.

R&D Expense
P&L
+46.8%
$97.2M$142.7M

R&D investment increased 46.8% — signals commitment to future product development, though near-term margin impact.

Net Income
P&L
-44.9%
-$115.9M-$167.9M

Net income declined 44.9% — review whether driven by operations, interest costs, or non-recurring items.

Capital Expenditure
Cash Flow
-44.4%
$2.2M$1.2M

Capex reduced 44.4% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Operating Income
P&L
-37.6%
-$125.1M-$172.2M

Operating income deteriorated sharply — investigate whether driven by one-time charges or structural cost issues.

Stockholders Equity
Balance Sheet
-26.4%
$152.3M$112.1M

Equity decreased 26.4% — buybacks or losses reducing book value, monitor solvency ratios.

Current Assets
Balance Sheet
-16.7%
$166.7M$138.9M

Current assets declined 16.7% — monitor working capital adequacy and short-term liquidity.

LANGUAGE CHANGES
NEW — 2026-03-23
PRIOR — 2025-03-31
ADDED
We may be unable to reach agreement with the FDA or comparable foreign regulatory authorities on the methodologies for, and assessment of, comparability of different versions of a product candidate used in non-pivotal studies, pivotal studies and for intended commercial use or may be unable to establish such comparability.
Our proprietary CABA , or Cabaletta Approach to B cell Ablation platform, focuses on the CARTA approach.
CARTA refers to Chimeric Antigen Receptor T cells for Autoimmunity and is designed to potentially reset the immune system.
Based on clinical data reported to date, we believe our CABA platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases and that it has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.
Resecabtagene autoleucel, or rese-cel (formerly referred to as CABA-201), is a 4-1BB co-stimulatory domain-containing fully human CD19-CAR T construct designed to treat patients with a broad range of autoimmune diseases and our lead product candidate within the CARTA strategy.
Rese-cel is designed to achieve transient and deep depletion of all B cells following a single, weight-based infusion of T cells that are engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells.
This approach has demonstrated the potential to reset the immune system and result in meaningful clinical responses without chronic therapy requirements in patients.
The efficacy and safety of rese-cel was recently reviewed along with all other commercial and academic constructs in development in a February 2026 Nature Biotechnology publication.
In December 2025, we initiated a registrational trial with rese-cel for patients with dermatomyositis or anti-synthetase syndrome.
In addition, we have ongoing Phase 1/2 trials evaluating rese-cel with a standard preconditioning regimen, fludarabine and cyclophosphamide, in systemic lupus erythematosus, or SLE, in patients with active lupus nephritis, or LN, or active SLE without renal involvement, systemic sclerosis, or SSc, and generalized myasthenia gravis, or gMG.
REMOVED
Our proprietary CABA , or Cabaletta Approach to B cell Ablation, platform encompasses two strategies.
Our CARTA, or Chimeric Antigen Receptor T cells for Autoimmunity, approach is designed to potentially reset the immune system.
Our legacy CAART, or Chimeric AutoAntibody Receptor T cells, approach is designed to engineer T cells to selectively engage and eliminate only disease-causing B cells.
We believe our CABA platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases and that it has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.
Resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) is a 4-1BB co-stimulatory domain-containing fully human CD19-CAR T construct designed to treat patients with a broad range of autoimmune diseases and our lead product candidate within the CARTA strategy.
Rese-cel is designed to achieve transient and deep depletion of all B cells following a single treatment by using T cells engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells.
This approach has the potential to reset the immune system, providing meaningful durable and complete clinical responses to patients off immunosuppressive therapies.
In March 2023, the United States Food and Drug Administration, or the FDA, granted clearance of our rese-cel Investigational New Drug, or IND, application for treatment of SLE in patients with active lupus nephritis, or LN, or active SLE without renal involvement.
SLE affects an estimated up to 320,000 patients in the U.S., and 150,000 patients in Europe, with LN as the most common end-organ manifestation, affecting approximately 40% of SLE patients.
In May 2023, we announced the FDA granted Fast Track Designation for rese-cel, designed to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN.
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