QNCXHIGH SIGNALREGULATORY10-K

Quince Therapeutics completed its pivotal Phase 3 NEAT trial for rare disease treatment eDSP, but the primary endpoint failed to reach statistical significance.

The failure of the Phase 3 trial represents a major setback for this biotechnology company that was substantially dependent on eDSP's success. With no approved products and no revenue from sales, QNCX now faces significant uncertainty about its lead asset and future development pathway, while simultaneously burning through cash at an accelerated rate.

Comparing 2026-04-10 vs 2025-03-24View on EDGAR →
FINANCIAL ANALYSIS

The company's financial position deteriorated meaningfully, with R&D expenses substantially higher as the Phase 3 trial progressed toward completion. Current assets declined nearly 50% while total liabilities grew notably, reflecting both the trial costs and likely equity dilution evidenced by the substantial increase in outstanding shares from 44 million to 163 million. Operating cash outflows increased by approximately 30%, indicating accelerated cash burn during this critical trial period.

FINANCIAL STATEMENT CHANGES
R&D Expense
P&L
+90.3%
$18.6M$35.4M

R&D investment increased 90.3% — signals commitment to future product development, though near-term margin impact.

Total Liabilities
Balance Sheet
+53.2%
$84.3M$129.2M

Liabilities grew 53.2% — significant increase in debt or obligations, assess impact on financial flexibility.

Current Assets
Balance Sheet
-48%
$44.0M$22.9M

Current assets declined 48% — monitor working capital adequacy and short-term liquidity.

Net Income
P&L
-47.8%
-$56.8M-$84.0M

Net income declined 47.8% — review whether driven by operations, interest costs, or non-recurring items.

Capital Expenditure
Cash Flow
+37%
$257K$352K

Capital expenditure jumped 37% — major investment cycle underway; assess returns on deployment.

Operating Cash Flow
Cash Flow
-29.8%
-$31.9M-$41.4M

Operating cash flow softened — monitor whether temporary working capital timing or structural deterioration.

Total Assets
Balance Sheet
-18.3%
$114.5M$93.5M

Total assets contracted 18.3% — asset sales, write-downs, or balance sheet optimization underway.

LANGUAGE CHANGES
NEW — 2026-04-10
PRIOR — 2025-03-24
ADDED
As of April 9, 2026, the registrant had 163,007,943 shares of common stock, $0.001 par value per share, outstanding.
iii DEFINED TERMS Unless the context requires otherwise, references to Quince, the Company, we, us, or our in this Annual Report on Form 10-K refer to Quince Therapeutics, Inc.
Overview We are a biotechnology company and, prior to the completion of our NEAT Phase 3 trial, described below, focused our development activities on unlocking the power of a patient s own biology for the treatment of rare diseases.
Our lead asset, eDSP, used our AIDE technology to encapsulate DSP into a patient s own red blood cells.
In January 2026 we completed our pivotal Phase 3 NEAT clinical trial to evaluate the treatment of a rare pediatric neurodegenerative disease, A-T.
In the NEAT study, the primary endpoint, which measured the change from baseline to last efficacy visit at month six using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo, did not reach statistical significance.
Based on the results of the NEAT clinical trial, eDSP does not appear to be an effective treatment for A-T and we will be unable to continue development of eDSP in this or other therapeutic indications.
We have no other current product candidates and do not have sufficient resources to pursue further research and development activities at this time.
We are currently focused on preserving cash while we evaluate available strategic alternatives.
On February 9, 2026, we engaged LifeSci Capital as our exclusive financial advisor to assist in restructuring activities and an evaluation of strategic alternatives aimed at maximizing shareholder value.
REMOVED
As of March 13, 2025, the registrant had 44,001,643 shares of common stock, $0.001 par value per share, outstanding.
iii Table of Conten t Summary of Risk Factors We may be unable for many reasons, including those that are beyond our control, to implement our business strategy successfully.
The occurrence of any single risk or any combination of risks could materially and adversely affect our business, financial condition, results of operations, cash flows and the trading price of our common stock.
Some of these risks are: We are substantially dependent on the success of our lead drug candidate, eDSP.
The Phase 3 NEAT clinical trial of eDSP for A-T is being conducted under a protocol negotiated with FDA by EryDel and our execution of the trial may be slowed, may not be successful, and may not result in NDA approval, with adverse results for our business and share price.
We have no drug candidates approved for commercial sale, we have never generated any revenue from sales, and we may never be profitable.
We will need to raise substantial additional funding, which may not be available on acceptable terms, to finance our operations and to develop and evaluate current and future drug candidates.
If we are unable to raise this additional capital when needed or on acceptable terms, we may be forced to delay, limit, reduce, terminate or eliminate our drug development programs or other operations.
We have and may be required to make additional milestone payments to (i) EryDel shareholders pursuant to the terms of the EryDel Acquisition or (ii) additional remuneration payments to EIB pursuant to the EIB Loan in connection with our commercialization of eDSP, which could adversely affect the overall profitability of eDSP, if approved.
Clinical drug development is a lengthy, expensive and uncertain process.
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