# EDGAR Filing Document

**Accession Number:** 0001662774
**File Stem:** 0001193125-26-029524
**Filing Date:** 2026-1
**Character Count:** 11606
**Document Hash:** a126e2699a11b16cc163e70a1621d126
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-029524.hdr.sgml**: 20260129

**ACCESSION NUMBER**: 0001193125-26-029524

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260129

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260129

**DATE AS OF CHANGE**: 20260129

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Quince Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001662774
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 901024039
- **STATE OF INCORPORATION:** CA
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38890
- **FILM NUMBER:** 26578763

**BUSINESS ADDRESS:**
- **STREET 1:** 611 GATEWAY BLVD., SUITE 273
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080
- **BUSINESS PHONE:** 415-910-5717

**MAIL ADDRESS:**
- **STREET 1:** 611 GATEWAY BLVD., SUITE 273
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cortexyme, Inc.
- **DATE OF NAME CHANGE:** 20160104

?xml version='1.0' encoding='ASCII'? 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): January 29, 2026

## Quince Therapeutics, Inc.

#### (Exact name of Registrant as Specified in Its Charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38890** | **90-1024039** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **611 Gateway Boulevard**<br> **Suite 273** |  |
| **South San Francisco, California** | **94080** |
| **(Address of Principal Executive Offices)** | **(Zip Code)** |

---

#### Registrant's Telephone Number, Including Area Code: (415) 910-5717

#### (Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

#### Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, par value $0.001 per share | QNCX | Nasdaq Global Select Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

------

---

| | |
|:---|:---|
| **Item. 8.01** | **Other Events.**  |

---

On January 29, 2026, Quince Therapeutics, Inc. issued a press release announcing results from Pivotal Phase 3 NEAT Clinical Trial of eDSP in Ataxia-Telangiectasia. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

---

| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits**  |

---

(d) Exhibits

99.1 [Press Release issued by Quince Therapeutics, Inc. dated January 29, 2026.](d61547dex991.htm)

------

#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **QUINCE THERAPEUTICS, INC.** | **QUINCE THERAPEUTICS, INC.** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Date: January 29, 2026 | By: |  |
|  | Name: | Dirk Thye |
|  | Title: | Chief Executive Officer and Chief Medical Officer |

---

## Exhibit 99.1

**Exhibit 99.1** 

---

| | |
|:---|:---|
| ***NEWS RELEASE*** | ![LOGO](g61547g0130014414374.jpg) |

---

**Quince Therapeutics Announces Topline Results from** 

**Pivotal Phase 3 NEAT Clinical Trial of eDSP in Ataxia-Telangiectasia** 

*Primary and key secondary endpoint did not achieve statistical significance* 

*eDSP was generally well tolerated with no clinically meaningful safety concerns identified* 

*Company to cease clinical development of eDSP; Intends to preserve cash and explore available options* 

**SOUTH SAN FRANCISCO, Calif. – January 29, 2026 –** Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced topline results from its pivotal Phase 3 NEAT clinical trial evaluating its lead asset, dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP), in patients with Ataxia-Telangiectasia (A-T).

In the NEAT study, the company's pivotal Phase 3 international, multicenter, randomized, double-blind, placebo-controlled study (n=105), 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. The mean change from baseline to month six was 0.94 in the active arm compared to 2.24 in the placebo arm (difference -1.30) with a p-value of 0.0851. Furthermore, the study did not meet its key secondary endpoint of improvement in Clinical Global Impression of Severity (CGI-S) measured from baseline to month six with a p-value of 0.522.

eDSP was generally well tolerated and there were no clinically meaningful safety concerns identified. The most common adverse events reported in the eDSP arm included pruritis and pyrexia.

Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "We express our compassion and hope for future therapeutic options to the A-T community. We have tremendous gratitude toward the patients, their families, academic investigators and study sites, as well as all Quince employees, who worked so diligently over many years on this program."

**About Pivotal Phase 3 NEAT Clinical Trial** 

NEAT (**N**eurological **E**ffects of eDSP in Subjects with **A**-**T**; <u>NCT06193200/IEDAT-04-2022</u>) was an international, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP in patients with A-T. A total of 105 participants were randomized across leading academic centers, including four clinical sites in the U.S. and 18 in the U.K. and Europe. The study consisted of two cohorts randomized (1:1) between eDSP or placebo and the treatment included six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint was measured by the change from baseline to last efficacy visit at month six using RmICARS compared to placebo. RmICARS is a refined version of the International Cooperative Ataxia Rating Scale (ICARS), a standard, clinician-administered tool used to quantify ataxia severity, which places increased focus on posture and gait disturbance with higher sensitivity in children ages six to 10 years old.

*611 Gateway Boulevard • Suite 273 • South San Francisco • California • 94080* 

------

*Quince Therapeutics* 

*Page 2* 

Quince enrolled a total of 105 participants in the NEAT study, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older. Participants who completed the full treatment period, completed study assessments, and provided informed consent were eligible to transition to the company's open label extension (OLE) study (<u>NCT06664853/IEDAT-04-2024</u>). All but one of the participants elected to transition to the 24-month OLE.

**About Ataxia-Telangiectasia** 

A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy.

Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T.

**About eDSP** 

eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.

eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.

**About Quince Therapeutics** 

Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit <u>www.quincetx.com</u> and follow Quince on social media platforms <u>LinkedIn</u>, <u>Facebook</u>, <u>X</u>, and <u>YouTube</u>.

------

*Quince Therapeutics* 

*Page 3* 

**Forward-looking Statements** 

**Media & Investor Contact:** 

Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

<u>ir@quincetx.com</u>