ACLXHIGH SIGNALFINANCIAL10-K

ACLX experienced a substantial decline in revenue alongside meaningfully higher operating losses, indicating significant deterioration in the company's financial performance.

The sharp revenue contraction combined with substantially expanded operating losses suggests the company may be facing challenges with its commercialization efforts or partnership agreements. As a clinical-stage biotech, this financial deterioration raises concerns about the company's ability to fund ongoing clinical trials and operations without additional capital raises, particularly given the declining cash position.

Comparing 2026-02-26 vs 2025-02-27View on EDGAR →
FINANCIAL ANALYSIS

ACLX's financial performance deteriorated meaningfully, with revenue declining substantially while operating losses expanded significantly year-over-year. The company's balance sheet contracted across key metrics, with cash and equivalents falling 24% to $80.3M and total assets declining 15% to $604.0M. While the company reduced total liabilities by 21%, the combination of lower revenue, higher losses, and declining cash reserves signals potential funding pressures ahead for this clinical-stage biotechnology company.

FINANCIAL STATEMENT CHANGES
Operating Income
P&L
-84%
-$137.6M→-$253.1M

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

Capital Expenditure
Cash Flow
-82.7%
$13.4M→$2.3M

Capex reduced 82.7% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Revenue
P&L
-79.4%
$107.9M→$22.3M

Revenue declined 79.4% — significant demand weakness or market share loss warrants investigation.

Cash & Equivalents
Balance Sheet
-24.1%
$105.7M→$80.3M

Cash decreased 24.1% — monitor burn rate and upcoming capital needs.

Current Assets
Balance Sheet
-22.9%
$599.3M→$462.2M

Current assets declined 22.9% — monitor working capital adequacy and short-term liquidity.

Total Liabilities
Balance Sheet
-21.4%
$256.5M→$201.6M

Liabilities reduced 21.4% — deleveraging improves balance sheet strength and financial flexibility.

Current Liabilities
Balance Sheet
-16.9%
$125.4M→$104.2M

Current liabilities reduced — improved short-term financial position and working capital health.

Total Assets
Balance Sheet
-15.1%
$711.3M→$604.0M

Total assets contracted 15.1% — asset sales, write-downs, or balance sheet optimization underway.

Stockholders Equity
Balance Sheet
-11.5%
$454.8M→$402.4M

Equity decreased 11.5% — buybacks or losses reducing book value, monitor solvency ratios.

LANGUAGE CHANGES
NEW — 2026-02-26
PRIOR — 2025-02-27
ADDED
Overview We are a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases.
Although Chimeric Antigen Receptor T-cells (CAR-Ts) have shown benefits to date, they have primarily been constrained to existing biologic structures, which has limited their impact and opportunity.
Our novel synthetic binding scaffold, the D-Domain, is designed to overcome the limitations of traditional CAR-Ts.
Our lead program is a BCMA-targeting ddCAR product candidate called anitocabtagene autoleucel or anito-cel (formerly, CART-ddBCMA), which is currently being evaluated in our pivotal Phase 2 iMMagine-1, Phase 3 iMMagine-3, and Phase 2 GEM-AnitoFIRST trials in patients with multiple myeloma (MM).
In 2024, we completed dosing in our pivotal Phase 2 clinical trial (iMMagine-1) of anito-cel in patients with fourth line or later relapsed or refractory MM (rrMM).
In December 2025, we announced interim data from our pivotal iMMagine-1 study in patients with rrMM after three or more prior lines of therapy, which were presented during an oral presentation at the 67th ASH Annual Meeting and Exposition.
Kite is manufacturing anito-cel for iMMagine-3 and expects the trial to be fully enrolled by mid-2026.
On December 23, 2025, we submitted a BLA for anito-cel to treat patients with fourth line or later rrMM to the FDA.
On February 20, 2026, the FDA notified us that it has accepted our BLA with an anticipated PDUFA action date of December 23, 2026.
On February 22, 2026, we entered into an Agreement and Plan of Merger (the Merger Agreement) with Gilead and Purchaser, as described in more detail in "Pending Acquisition by Gilead" below (the Merger).
REMOVED
Overview We are a clinical-stage biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases.
Although cell therapies have shown benefits to date, cell therapies have primarily been constrained to existing biologic structures, which has limited their impact and opportunity.
Our novel synthetic binding scaffold, the D-Domain, is designed to overcome the limitations of traditional Chimeric Antigen Receptor T-cells (CAR-Ts).
Our lead program is a BCMA-targeting ddCAR product candidate called anitocabtagene autoleucel or anito-cel (formerly, CART-ddBCMA), which is currently being evaluated in our pivotal Phase 2 iMMagine-1 and the Phase 3 iMMagine-3 trials in patients with relapsed or refractory multiple myeloma (rrMM).
We received FDA clearance of an IND application and have initiated a Phase 1 trial in generalized myasthenia gravis (gMG) in 2024.
We also are developing two clinical-stage ARC-SparX programs in Phase 1 trials: ACLX-001, which targets BCMA in rrMM; and our wholly-owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
In December 2024, at the Annual Meeting of the American Society of Hematology (ASH), we presented preliminary data from our pivotal Phase 2 iMMagine-1 trial evaluating anito-cel, in patients with rrMM.
We believe these results, along with the data from our Phase 1 clinical trial evaluating anito-cel in rrMM, further demonstrate that our D-Domain technology can potentially provide meaningful clinical benefits.
As of the October 31, 2024 data cutoff date for the iMMagine-1 ASH presentation, 86 patients were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel.
Data were assessed using the 2016 International Myeloma Working Group (IMWG) uniform response criteria for MM.
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