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Quince Therapeutics, Inc.

For the period ended Jun 30, 2025. Filed Aug 11, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 11, 2025

QNCX$31.73+8.1%Stored close · as of Oct 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Table of Contents

Page
PART I. · FINANCIAL INFORMATION
Item 1.Financial Statements (Unaudited)1
Condensed Consolidated Balance Sheets1
Condensed Consolidated Statements of Operations and Comprehensive Loss2
Condensed Consolidated Statements of Stockholders’ Equity3
Condensed Consolidated Statements of Cash Flows5
Notes to Unaudited Condensed Consolidated Financial Statements6
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations29
Item 3.Quantitative and Qualitative Disclosures About Market Risk40
Item 4.Controls and Procedures40
PART II.OTHER INFORMATION
Item 1.Legal Proceedings41
Item 1A.Risk Factors41
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds42
Item 3.Defaults Upon Senior Securities42
Item 4.Mine Safety Disclosures42
Item 5.Other Information42
Item 6.Exhibits43
Signatures45

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "expect," "objective," "plan," "potential," "seek," "grow," "target," "if," and similar expressions intended to identify forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, including risks described in the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q and in our other filings with the Securities and Exchange Commission (the "SEC"). It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this Quarterly Report on Form 10-Q may not occur, and actual results may differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

our ability to successfully execute on our current strategic direction;

future research and development activities, including the scope, success, cost and timing of any future development activities, preclinical studies and clinical trials, including clinical trials of eDSP or other pipeline compounds we advance through the drug development process;

the timing and focus of any potential future clinical trials, and the reporting of data from those trials;

our ability and timing of seeking and obtaining FDA and any other regulatory approvals for our drug candidates;

the willingness of the FDA or other regulatory authorities to accept any future completed or planned clinical and preclinical studies and other work, as the basis for review and approval of our drug candidates for their respective indications;

whether regulatory authorities determine that additional trials or data are necessary in order to accept a new drug application for review and/or approval;

the ability of any future clinical trials to demonstrate safety and efficacy of eDSP and other drug candidates, and other positive results;

our financial performance;

our ability to continue as a going concern, the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements;

the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;

our expectations related to the use of our available cash;

our ability to service our debt obligations and maintain compliance with associated covenants;

our ability to obtain funding for our operations, including funding necessary to develop and commercialize our drug candidates;

our expectations regarding the potential market size and the size of the patient populations for our drug candidates, if approved for commercial use, and the potential market opportunities for commercializing our drug candidates;

our plans relating to commercializing our drug candidates, if approved;

our plans and ability to establish sales, marketing and distribution infrastructure to commercialize any drug candidates for which we obtain approval;

our ability to attract and retain key scientific and clinical personnel;

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

our reliance on third parties to conduct clinical trials of our drug candidates, and for the manufacture of our drug candidates for preclinical studies and clinical trials;

dependence upon the integrity of our supply chain, including multiple single-source suppliers;

our reliance on third-party suppliers for certain of our raw materials and components;

our ability to expand our drug candidates into additional indications and patient populations;

the success of competing therapies that are or may become available;

the beneficial characteristics, safety and efficacy of our drug candidates;

governmental or regulatory delays, information requests, clinical holds, and regulatory developments in the United States and other jurisdictions;

our ability to obtain and maintain regulatory approval of our drug candidates, and any related restrictions, limitations and/or warnings in the label of any approved drug candidate;

our ability to obtain and maintain CE Certificates of conformity for the medical device components of our eDSP System in accordance with applicable legislation governing medical devices;

our ability to transition CE Certifications under the previous Medical Device Directive, to a regulatory framework under MDR;

our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;

the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates and technology;

potential claims relating to our intellectual property;

our ability to grow our organization and increase the size of our facilities to meet our anticipated growth; and

our ability to maintain compliance with Nasdaq listing requirements.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

You should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we do not intend to update any of these forward-looking statements after the date of this Quarterly Report on Form 10-Q or to conform these statements to actual results or revised expectations.

You should read this Quarterly Report on Form 10-Q with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

This Quarterly Report on Form 10-Q contains estimates, projections and other information concerning our industry, our business and the markets for our drug candidates. We obtained the industry, market and similar data set forth in this report from our own internal estimates and research and from academic and industry research, publications, surveys and studies conducted by third parties, including governmental agencies. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. While we believe that the data we use from third parties are reliable, we have not separately verified these data. Further, while we believe our internal research is reliable, such research has not been verified by any third party. You are cautioned not to give undue weight to any such information, projections and estimates.

DEFINED TERMS

Unless the context requires otherwise, references to “Quince,” “the Company,” “we,” “us,” or “our” in this Quarterly Report on Form 10-Q refer to Quince Therapeutics, Inc. and its consolidated subsidiaries. We also have used several other terms in this Quarterly Report on Form 10-Q, most of which are explained or defined below.

Abbreviated TermDefined Term
AIDEAutologous Intracellular Drug Encapsulation
ASCAccounting Standards Codification
ASUAccounting Standards Update
A-TAtaxia-Telangiectasia
ATTeSTAtaxia Telangiectasia Trial with the eDSP System
the CodeInternal Revenue Code of 1986, as amended
CODMChief Operating Decision Maker
COVID-19Coronavirus disease
CreditsTax credits
CROContract Research Organization
CTREuropean Union pharmaceutical legislation known as the Clinical Trials Regulation
Debt AgreementUnsecured line of credit agreement between EryDel and the European Investment Bank, which the Company guaranteed on October 20, 2023 in connection with the EryDel Acquisition
DMDDuchenne muscular dystrophy
DSPDexamethasone Sodium Phosphate
ECEuropean Commission
EryDelQuince Therapeutics, S.p.A (previously named EryDel S.p.A.)
eDSPEncapsulated dexamethasone sodium phosphate encapsulated in patient's own red blood cells (previously referred to as EryDex)
eDSP SystemAutomated combination product to encapsulate dexamethasone sodium phosphate in red blood cells
EIBEuropean Investment Bank
EUEuropean Union
EIB LoanUnsecured line of credit between EryDel and the European Investment Bank
Exchange ActSecurities Exchange Act of 1934, as amended
FASBFinancial Accounting Standards Board
FDAUnited States Food and Drug Administration
GAAPgenerally accepted accounting principles in the United States
GMPGood Manufacturing Practice
HHSUnited States Department of Health and Human Services
ICARSInternational Cooperative Ataxia Rating Scale
IPR&DIn-process Research and Development
IRAInflation Reduction Act of 2022
LighthouseLighthouse Pharmaceuticals, Inc.
MAAMarketing Authorization Application
MDRMedical Devices Regulation 2017/745
MPEEMMulti-Period Excess Earnings Method
NasdaqThe Nasdaq Stock Market LLC
NDANew Drug Application
NEATeDSP Phase 3 Clinical Trial (Neurological Effects of eDSP on Subjects with A-T)
NovosteoNovosteo, Inc.
OLEOpen-Label Extension Clinical Trial
PDPharmacodynamic
PKPharmacokinetic
PRFPurdue Research Foundation
R&DResearch and Development
RBCRed Blood Cell
RSARestricted Stock Awards
RSURestricted Stock Units
SAESerious Adverse Event
Sarbanes-Oxley ActThe Sarbanes-Oxley Act of 2002
SECUnited States Securities and Exchange Commission
Securities ActSecurities Act of 1933
SPASpecial Protocol Assessment
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.