# EDGAR Filing Document

**Accession Number:** 0001662774
**File Stem:** 0000950170-25-106536
**Filing Date:** 2025-8
**Character Count:** 19671
**Document Hash:** 28f164239c386b25f4e60797007d8a6b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-106536.hdr.sgml**: 20250811

**ACCESSION NUMBER**: 0000950170-25-106536

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250811

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250811

**DATE AS OF CHANGE**: 20250811

**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:** 251201977

**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**

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## **FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** August 11, 2025<br>

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Quince Therapeutics, Inc.

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

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| | | |
|:---|:---|:---|
| Delaware | 001-38890 | 90-1024039 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 601 Gateway Boulevard<br>Suite 1250 |  |  |
| South San Francisco**,** California |  | 94080 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (415) 910-5717<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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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:**

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

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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. ☐

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## **Item 2.02 Results of Operations and Financial Condition.** 
On August 11, 2025, Quince Therapeutics, Inc. (the "Company") announced its financial results for the quarter ended June 30, 2025 and provided recent business highlights. 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 2.02 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 9.01 Financial Statements and Exhibits.** 
(d) Exhibits.

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| | |
|:---|:---|
| **<u>Exhibit No.</u>** | **<u>Description</u>** |
| 99.1 | [<u>Press release issued by Quince Therapeutics, Inc. dated August 11, 2025</u>](qncx-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **QUINCE THERAPEUTICS, INC.** |
| Date: | August 11, 2025 | By:  | /s/ Dirk Thye |
|  |  | Name:<br>Title: | Dirk Thye<br>Chief Executive Officer and Chief Medical Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Quince Therapeutics Provides Business Update and Reports** 

**Second Quarter 2025 Financial Results**

*Marks major milestone with completion of enrollment in pivotal Phase 3 NEAT clinical trial* 

*evaluating lead asset, eDSP, for the treatment of A-T; topline results expected in first quarter of 2026*

*Closed financing priced at a premium bringing existing cash position to approximately $35 million; expected to provide runway through Phase 3 topline results and into at least second quarter of 2026* 

*Entered into strategic relationship with Option Care Health to support* 

*commercial launch of eDSP in the U.S.*

**SOUTH SAN FRANCISCO, Calif. – August 11, 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 provided an update on the company's development pipeline and reported financial results for the second quarter ended June 30, 2025.

Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "We achieved many critical milestones over the last quarter that significantly advance our research programs and strengthen our business model. Specifically, we completed enrollment in our pivotal Phase 3 NEAT clinical trial, secured additional financing to extend our operating runway sufficiently beyond topline results, and solidified our commercial development planning through our strategic partnership with Option Care Health. Quince remains confident in our ability to deliver topline results in the first quarter of 2026 and subsequent NDA submission in the second half of 2026, assuming positive study results."

**Pivotal Phase 3 NEAT Clinical Trial**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Quince completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; <u>NCT06193200</u>/<u>IEDAT-04-2022</u>) clinical trial with a total of 105 participants, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older.

&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;•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;•All 50 NEAT participants to date have elected to transition to the 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;•The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

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

&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.

&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.

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&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.

**Pipeline and Corporate Updates**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced a strategic relationship with Option Care Health, Inc. (Nasdaq: OPCH), the nation's largest independent provider of home and ambulatory infusion services, to support the commercial development and efficient launch of Quince's lead asset, eDSP in the U.S. The strategic relationship will leverage Option Care's robust network of specialty pharmacy and ambulatory infusion suites to provide for the administration of eDSP in an effective and efficient way while delivering this innovative treatment to patients with greater geographic flexibility.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Closed a private placement of common stock and accompanying warrants in June 2025 led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, Legend Capital Partners, and Lagfin S.C.A. new stockholder Second Line Capital, along with members of Quince's senior management. Priced at a more than a 10% premium to the market price of Quince's common stock, the financing resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying warrants are exercised in full, before deducting placement agent fees and other private placement expenses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Finalized Phase 2 clinical trial study designs to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD), the company's second targeted indication for its lead asset, eDSP. Quince plans to prioritize capital efficient study approaches, including potential investigator-initiated trials (IITs), to advance in the evaluation of DMD as a second targeted eDSP indication.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Initiated Study #3 in the company's European Union pediatric investigational plan (PIP) – named the **P**ediatric **E**ncapsulated **D**examethasone Sodium Phosphate (PeD) study – to evaluate the safety and pharmacokinetics of eDSP in younger patients with A-T who weigh between nine and 15 kilograms.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Participated at the 2025 A-T Clinical Research Conference organized by the A-T Society, a leading A-T patient advocacy group based in the United Kingdom, where key opinion leaders (KOLs) presented post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial, in addition to Quince management providing an overview of the Phase 3 NEAT clinical trial.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Appointed Dr. Hassan Abolhassani, Assistant Professor of Clinical Immunology and Research Specialists in the Department of Medical Biochemistry and Biophysics at the Karolinska Institutet in Stockholm, Sweden, to the company's Scientific Advisory Board (SAB). Dr. Abolhassani becomes the ninth member to join Quince's SAB, which is comprised of leading experts in A-T, biochemistry, neurology, immunology, genetic, hematology, pharmacology, and clinical practice.

**Second Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported cash, cash equivalents, and short-term investments of $34.7 million for the second quarter ended June 30, 2025. Quince expects its existing cash runway to be sufficient to fund the company's capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. If warrants related to the company's recent financing are exercised in full for cash, Quince's cash runway would extend into the second half of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported research and development (R&D) expenses of $6.6 million for the second quarter ended June 30, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported general and administrative (G&A) expenses of $3.3 million for the second quarter ended June 30, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported a net loss of $16.1 million, or a net loss of $0.34 per basic and diluted share, for the second quarter ended June 30, 2025. Weighted average shares outstanding for the year were 46.7 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported net cash used in operating activities of $21.0 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to net loss of $31.1 million for the period, adjusted for $9.9 million of non-cash items, including $4.5 million change in the fair value of warrants, $2.7 million in stock-based compensation, $2.5 million change in the fair value of contingent consideration liabilities, $0.8 million change in the fair value of the European Investment Bank loan and a net decrease in operating assets of $0.5 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $0.3 million.

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**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 www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.

**Forward-looking Statements** 

&nbsp;&nbsp;**Media & Investor Contact:**<br>Stacy Roughan<br>Quince Therapeutics, Inc.<br>Vice President, Corporate Communications & Investor Relations<br>ir@quincetx.com<br>

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**QUINCE THERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

*(Unaudited)*

*(In thousands except share amounts)*

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| | | |
|:---|:---|:---|
|  | **June 30, 2025** | **December 31, 2024** |
| **ASSETS** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $16826 | $6212 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 17882 | 34572 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 2637 | 3252 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 37345 | 44036 |
| Property and equipment, net | 573 | 315 |
| Operating lease right-of-use assets | 507 | 498 |
| Intangible assets | 67566 | 60045 |
| Other assets | 11219 | 9584 |
| Total assets | $117210 | $114478 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $1759 | $2903 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 5708 | 4375 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 7467 | 7278 |
| Long-term debt | 16989 | 14321 |
| Long-term operating lease liabilities | 387 | 394 |
| Long-term contingent consideration | 59147 | 56691 |
| Deferred tax liabilities | 5595 | 4963 |
| Warrant liabilities | 15144 |  |
| Other long-term liabilities | 745 | 685 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 105474 | 84332 |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Preferred stock, $0.001 par value, 10,000,000 authorized, no shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively. |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Common stock, $0.001 par value, 250,000,000 shares authorized, 53,624,180 and 44,001,643 issued and outstanding as of June 30, 2025 and December 31, 2024, respectively. | 53 | 44 |
| &nbsp;&nbsp;&nbsp;&nbsp;Additional paid in capital | 413078 | 406609 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive income (loss) | 6156 | (35) |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (407551) | (376472) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 11736 | 30146 |
| Total liabilities and stockholders' equity | $117210 | $114478 |

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**QUINCE THERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS**

*(Unaudited)*

*(In thousands, except share and per share amounts)*

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended June 30,** | **Six Months Ended June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | $6553 | $4147 | $14698 | $7849 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 3342 | 4695 | 8131 | 9666 |
| &nbsp;&nbsp;&nbsp;&nbsp;Goodwill impairment charge |  | 17130 |  | 17130 |
| &nbsp;&nbsp;&nbsp;&nbsp;Fair value adjustment for contingent consideration | 532 | 2220 | 2456 | 4765 |
| Total operating expenses | 10427 | 28192 | 25285 | 39410 |
| Loss from operations | (10427) | (28192) | (25285) | (39410) |
| Fair value adjustment for long-term debt | (501) | (415) | (945) | (803) |
| Fair value adjustment for warrants | (4464) |  | (4464) |  |
| Warrant issuance costs | (872) |  | (872) |  |
| Interest income | 311 | 823 | 717 | 1710 |
| Other income (expense), net | (29) | 91 | (116) | (308) |
| Net loss before income tax expense | (15982) | (27693) | (30965) | (38811) |
| Income tax expense | (67) | (36) | (114) | (67) |
| Net loss | (16049) | (27729) | (31079) | (38878) |
| Other comprehensive loss: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Foreign currency translation adjustments | 4216 | (726) | 6261 | (1955) |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized gain (loss) on available-for-sale securities | (17) | (12) | (70) | (5) |
| Total comprehensive loss | $(11850) | $(28467) | $(24888) | $(40838) |
| Net loss per share - basic and diluted | $(0.34) | $(0.64) | $(0.69) | $(0.90) |
| Weighted average shares of common stock outstanding - basic and diluted | 46686239 | 43096374 | 45314234 | 43053351 |

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