# EDGAR Filing Document

**Accession Number:** 0001662774
**File Stem:** 0001193125-25-159886
**Filing Date:** 2025-7
**Character Count:** 12938
**Document Hash:** 0dddf8c54225c1059195983613ce2aab
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-159886.hdr.sgml**: 20250716

**ACCESSION NUMBER**: 0001193125-25-159886

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20250716

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250716

**DATE AS OF CHANGE**: 20250716

**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:** 251127761

**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): July 16, 2025

## 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.)** |

---

---

| | |
|:---|:---|
| **601 Gateway Boulevard, Suite 1250**<br> **South San Francisco, California** | **94080** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

(415) 910-5717

#### (Registrant's telephone number, including area code)

#### Not Applicable

#### (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 (see General Instruction A.2. below):

☐ 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 240.13d-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 | The Nasdaq Stock Market LLC |

---

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 7.01** | **Regulation FD Disclosure.**  |

---

On July 16, 2025, Quince Therapeutics, Inc. (the "Company") announced the completion of patient enrollment in its pivotal Phase 3 NEAT clinical trial to evaluate its lead asset, eDSP, for the treatment of Ataxia-Telangiectasia. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

---

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

---

On July 16, 2025, the Company announced the completion of patient enrollment in its pivotal Phase 3 NEAT clinical trial to evaluate its lead asset, eDSP, for the treatment of Ataxia-Telangiectasia. A total of 105 participants were enrolled, including 83 participants in the six- to nine-year-old primary analysis population and 22 participants aged 10 years or older.

---

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

---

(d) Exhibits.

---

| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | [Press release issued by Quince Therapeutics, Inc. dated July 16, 2025](d71020dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, 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.** |
| Date: July 16, 2025 | By: | /s/ Dirk Thye |
|  | Name: | Dirk Thye |
|  | Title: | Chief Executive Officer and Chief Medical Officer |

---

## Exhibit 99.1

**Exhibit 99.1** 

---

| | |
|:---|:---|
| ![LOGO](g71020g22m25.jpg) | ![LOGO](g71020g0716235906723.jpg) |

---

**Quince Therapeutics Completes Enrollment in** 

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

**SOUTH SAN FRANCISCO, Calif. – July 16, 2025 –** 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 that the company has completed enrollment in its pivotal Phase 3 NEAT (**N**eurological **E**ffects of eDSP on Subjects with **A**-**T**; <u>NCT06193200</u>/<u>IEDAT-04-2022</u>) clinical trial to evaluate its lead asset, eDSP, for the treatment of the rare neurodegenerative disease Ataxia-Telangiectasia (A-T).

Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "The completion of enrollment in our pivotal Phase 3 NEAT clinical trial evaluating eDSP for the treatment of A-T is a major milestone for Quince that places us one step closer to advancing a first-to-market treatment for this devasting disease. We are confident that we have executed a well-designed study with a high degree of scientific integrity and vigilant operational oversight. Quince remains on track to deliver topline results in the first quarter of 2026 and positive results will lead to an NDA submission in the second half of 2026."

Key Phase 3 NEAT clinical trial enrollment highlights include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A total of 105 participants were enrolled, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years or older.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Quince expects to report topline results from its Phase 3 NEAT clinical trial in the first quarter of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Concluding the NEAT study with 83 enrolled participants in the six to nine year-old primary analysis population reflects powering of approximately 90% to determine statistical significance of the primary endpoint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• All NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study
(<u>NCT06664853</u> / <u>IEDAT-04-2022</u>). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to
transition to the OLE study.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) in the second half of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the
FDA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Quince was granted FDA Fast Track designation for the company's eDSP System for the treatment of patients
with A-T based on the potential to address a high unmet medical need.

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

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*Quince Therapeutics* 

*Page 2*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate
the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once
every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.

**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 for A-T** 

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>.

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*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>