IRulya Therapeutics Inc 8-K, filed Nov 12, 2025
IRulya Therapeutics Inc. (IRLA)
About this 8-K
IRulya Therapeutics Inc filed this 8-K on November 12, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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
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(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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 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.
Exhibit No. |
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Description |
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99.1 |
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Press release issued by Quince Therapeutics, Inc. dated November 12, 2025 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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. |
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Date: |
November 12, 2025 |
By: |
/s/ Dirk Thye |
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Name: |
Dirk Thye |
Exhibit 99.1
Quince Therapeutics Provides Business Update and Reports
Third Quarter 2025 Financial Results
Pivotal Phase 3 NEAT clinical trial evaluating lead asset, eDSP, for the treatment of A-T
remains on track with topline results expected in first quarter of 2026
SOUTH SAN FRANCISCO, Calif. – November 12, 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 third quarter ended September 30, 2025.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “Quince remains on track to report topline results for our pivotal Phase 3 NEAT clinical trial evaluating our lead asset eDSP (encapsulated dexamethasone sodium phosphate) for the treatment of Ataxia-Telangiectasia (A-T) in the first quarter of 2026. The NEAT study is powered at approximately 90% to test for a statistically significant difference between eDSP and placebo, and data management metrics suggest low rates of missing data and study discontinuations. Additionally, all patients completing the NEAT study have elected to participate in the open label extension (OLE) study. We also recently received a positive outcome of a NEAT safety analysis conducted by an independent data and safety monitoring board (iDSMB), which recommended that the study continue without any modifications. All of these factors support our ongoing confidence in a successful outcome for our pivotal Phase 3 NEAT clinical trial.”
Pivotal Phase 3 NEAT Clinical Trial
Pipeline and Corporate Updates
Third Quarter 2025 Financial Results
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
Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing and outcome of Phase 3 NEAT topline results and submission of a related NDA; expected cash position and operating runway, including cash potentially receivable upon the exercise of warrants; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP, including the anticipated benefits of the strategic partnership with Option Care Health; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; potential benefits of eDSP and the company’s market opportunity; and potential benefits from the
company’s investment in Lighthouse Pharmaceuticals. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on August 11, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
Media & Investor Contact:
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QUINCE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands except share amounts)
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September 30, 2025 |
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December 31, 2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
6,452 |
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$ |
6,212 |
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Short-term investments |
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19,836 |
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34,572 |
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Prepaid expenses and other current assets |
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2,914 |
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3,252 |
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Total current assets |
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29,202 |
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44,036 |
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Property and equipment, net |
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616 |
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315 |
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Operating lease right-of-use assets |
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481 |
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498 |
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Intangible assets |
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67,726 |
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60,045 |
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Other assets |
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11,874 |
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9,584 |
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Total assets |
$ |
109,899 |
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$ |
114,478 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ |
3,403 |
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$ |
2,903 |
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Accrued expenses and other current liabilities |
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5,121 |
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4,375 |
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Current portion of debt |
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17,520 |
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— |
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Total current liabilities |
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26,044 |
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7,278 |
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Debt |
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— |
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14,321 |
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Long-term operating lease liabilities |
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359 |
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394 |
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Long-term contingent consideration |
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61,213 |
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56,691 |
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Deferred tax liabilities |
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5,593 |
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4,963 |
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Warrant liabilities |
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14,853 |
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— |
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Other long-term liabilities |
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778 |
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685 |
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Total liabilities |
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108,840 |
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84,332 |
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Stockholders’ equity: |
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Preferred stock, $0.001 par value, 10,000,000 authorized, no shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. |
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— |
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— |
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Common stock, $0.001 par value, 250,000,000 shares authorized, 54,494,965 and 44,001,643 issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. |
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54 |
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44 |
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Additional paid in capital |
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415,705 |
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406,609 |
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Accumulated other comprehensive income (loss) |
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6,293 |
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(35 |
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Accumulated deficit |
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(420,993 |
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(376,472 |
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Total stockholders’ equity |
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1,059 |
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30,146 |
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Total liabilities and stockholders’ equity |
$ |
109,899 |
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$ |
114,478 |
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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 September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
$ |
8,083 |
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$ |
4,916 |
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$ |
22,781 |
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$ |
12,765 |
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General and administrative |
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3,281 |
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3,630 |
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11,412 |
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13,296 |
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Goodwill impairment charge |
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— |
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— |
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— |
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17,130 |
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Fair value adjustment for contingent consideration |
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2,066 |
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(2,683 |
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4,522 |
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2,082 |
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Total operating expenses (1) |
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13,430 |
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5,863 |
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38,715 |
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45,273 |
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Loss from operations |
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(13,430 |
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(5,863 |
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(38,715 |
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(45,273 |
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Fair value adjustment for debt |
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(549 |
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(449 |
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(1,494 |
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(1,252 |
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Fair value adjustment for warrants |
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291 |
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— |
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(4,173 |
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— |
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Warrant issuance costs |
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(42 |
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— |
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(914 |
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— |
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Interest income |
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300 |
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683 |
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1,017 |
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2,393 |
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Other income (expense), net |
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(58 |
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150 |
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(174 |
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(158 |
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Net loss before income tax expense |
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(13,488 |
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(5,479 |
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(44,453 |
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(44,290 |
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Income tax benefit (expense) |
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46 |
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(13 |
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(68 |
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(80 |
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Net loss |
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(13,442 |
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(5,492 |
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(44,521 |
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(44,370 |
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Other comprehensive loss: |
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Foreign currency translation adjustments |
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125 |
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2,158 |
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6,386 |
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203 |
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Unrealized gain (loss) on available-for-sale securities |
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12 |
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174 |
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(58 |
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169 |
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Total comprehensive loss |
$ |
(13,305 |
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$ |
(3,160 |
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$ |
(38,193 |
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$ |
(43,998 |
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Net loss per share - basic and diluted |
$ |
(0.25 |
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$ |
(0.13 |
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$ |
(0.92 |
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$ |
(1.03 |
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Weighted average shares of common stock outstanding - basic and diluted |
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53,951,371 |
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43,164,136 |
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48,234,306 |
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43,090,632 |
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(1) Expenses include the following amount of non-cash stock-based compensation expense.
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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General and administrative expense |
$ |
820 |
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$ |
786 |
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$ |
2,606 |
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$ |
3,096 |
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Research and development expense |
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435 |
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338 |
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1,308 |
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525 |
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Total stock-based compensation |
$ |
1,255 |
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$ |
1,124 |
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$ |
3,914 |
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$ |
3,621 |
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