IRulya Therapeutics Inc 8-K, filed Mar 24, 2025
IRulya Therapeutics Inc. (IRLA)
8-K
2025-03-24
For: 2025-03-24
View Original
Added on
April 05, 2026
About this 8-K
IRulya Therapeutics Inc filed this 8-K on March 24, 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
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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): March 24, 2025
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: ( | ||||||||
Not Applicable
(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 (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 Symbol(s) | Name of each exchange on which registered | ||||||||||||
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 o
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. o
Item 2.02 Results of Operations and Financial Condition.
On March 24, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the fiscal year ended December 31, 2024 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. | Description | |||||||
| 99.1 | ||||||||
| 104 | 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.
| QUINCE THERAPEUTICS, INC. | ||||||||
| By: | /s/ Dirk Thye | |||||||
Date: March 24, 2025 | Name: | Dirk Thye | ||||||
| Title: | Chief Executive Officer and Chief Medical Officer | |||||||
Exhibit 99.1
Quince Therapeutics Provides Business Update and
Reports Fiscal Year 2024 Financial Results
Phase 3 NEAT clinical trial exceeds 50% enrollment with new study site activations
expected to accelerate screenings and randomization
Existing cash position of $40.8 million expected to provide operating runway
through Phase 3 topline results into 2026
SOUTH SAN FRANCISCO, Calif. – March 24, 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 fiscal year ended December 31, 2024.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “Our Phase 3 pivotal NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized. Recent and upcoming new site activations are expected to accelerate enrollment through our target completion date in the second quarter of 2025. Assuming target enrollment completion, topline results from the NEAT study are anticipated in the fourth quarter of 2025.”
Pivotal Phase 3 NEAT Clinical Trial
•Enrolled 61 participants to date in the company’s Phase 3 NEAT (Neurologic Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate the neurological effects of eDSP (previously referred to as EryDex) in patients with Ataxia-Telangiectasia (A-T), including 54 participants in the six to nine year-old primary analysis population.
•Transitioned 24 participants to date to the NEAT open label extension study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to an open label extension study.
•Expect screening and randomization to accelerate in the coming weeks due to several new geographic regions and sites scheduled for activation.
•Quince plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.
•Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
•Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.
•NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
•Participants will be randomized (1:1) between eDSP or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the SPA agreement with the FDA.
Pipeline and Corporate Updates
•Generating Phase 2 clinical trial study designed to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD). Quince plans to initiate a DMD Phase 2 study in 2025, which the
company expects to conduct utilizing capital efficient study approaches and with financial support from grant and/or opportunistic funding opportunities.
•Published long-term safety data from patients with A-T treated with eDSP for a minimum of 24 months in Frontiers in Neurology in January 2025. The online publication titled Long-term safety of dexamethasone sodium phosphate encapsulated in autologous erythrocytes in pediatric patients with Ataxia-Telangiectasia can be accessed here.
•Appointed Dr. William Whitehouse, Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham and recently retired Consultant Pediatric Neurologist at Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust, to the company’s Scientific Advisory Board (SAB).
•Strengthened Quince’s growing intellectual property portfolio and long-term market position with the issuance of a Notice of Allowance from the U.S. Patent and Trademark Office’s (USPTO) in February 2025. This extends the company’s patent claims into 2036 in the U.S., supplementing its existing U.S. patent with coverage of patent claims related to method of treating patients with A-T using Quince’s proprietary process to encapsulate DSP in autologous red blood cells.
•Held an investor webinar in February 2025 featuring key opinion leader (KOL) Dr. Mary Kay Koenig from UTHealth Houston with a discussion focused on addressing the high unmet need in A-T. During the investor webinar, Dr. Koenig 1) provided an A-T natural history overview, 2) detailed current symptomatic treatment approaches for patients with A-T, 3) discussed the competitive therapeutic A-T landscape, and 4) provided an overview of Quince’s Phase 3 NEAT clinical trial of eDSP for the treatment of A-T. A replay of the A-T KOL investor webinar is available here.
Fiscal Year 2024 Operating Highlights
•Granted Fast Track designation from the FDA for Quince’s eDSP System for the treatment of patients with A-T in June 2024.
•Published efficacy and safety results from the company’s Phase 3 ATTeST clinical trial evaluating eDSP for the treatment of A-T in medical journal The Lancet Neurology.
•Participated at notable scientific meetings, including poster presentations at the 53rd Child Neurology Society (CNS) Annual Meeting and the 2024 International Congress for Ataxia Research (ICAR), where Quince presented data from its Phase 3 ATTeST clinical trial.
•Completed an initial patient sizing project based on third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that the number of diagnosed patients with A-T in the U.S. is estimated to be to approximately 4,600.
•Established a SAB comprised of leading experts in biochemistry, neurology, immunology, hematology, pharmacology, and clinical practice uniquely positioned to provide Quince with deep insights and advice to support advancement of the company’s drug programs.
Fiscal Year 2024 Financial Results
•Reported cash, cash equivalents, and short-term investments of $40.8 million for the fiscal year ended December 31, 2024. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results and into 2026. The company plans to be opportunistic from a financing perspective to extend its existing cash runway.
•Reported research and development (R&D) expenses of $18.6 million for the fiscal year ended December 31, 2024. R&D expenses during the year primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs.
•Reported general and administrative (G&A) expenses of $17.6 million for the fiscal year ended December 31, 2024. G&A expenses for the year primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.
•Reported a net loss of $56.8 million, or a net loss of $1.31 per basic and diluted share, for the fiscal year ended December 31, 2024. Weighted average shares outstanding for the year were 43.3 million.
•Reported net cash used in operating activities of $31.9 million for the year ended December 31, 2024. Cash used in operating activities was primarily due to a net loss of $56.8 million for the period, adjusted for $25.4 million of non-cash items, including $17.1 million goodwill impairment charge, $4.7 million in stock-based compensation, $4.0 million change in the fair value of contingent consideration liabilities, $1.7 million change in the fair value of the long-term debt and a net increase in operating assets of $2.6 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $2.1 million.
•Made a cash milestone payment of $5.0 million to EryDel shareholders in the third quarter of 2024, following the achievement of the first patient enrolled in the NEAT study in the second quarter of 2024.
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 plans and the ability to enroll participants, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support, including from grant or opportunistic funding opportunities; 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; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company’s market opportunity. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2024, 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: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations ir@quincetx.com | ||
QUINCE THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands except share amounts)
| December 31, 2024 | December 31, 2023 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 6,212 | $ | 20,752 | |||||||
| Short-term investments | 34,572 | 54,307 | |||||||||
| Prepaid expenses and other current assets | 3,252 | 2,381 | |||||||||
| Total current assets | 44,036 | 77,440 | |||||||||
| Property and equipment, net | 315 | 234 | |||||||||
| Operating lease right-of-use assets | 498 | 385 | |||||||||
| Goodwill | — | 17,625 | |||||||||
| Intangible assets | 60,045 | 63,672 | |||||||||
| Other assets | 9,584 | 8,544 | |||||||||
| Total assets | $ | 114,478 | $ | 167,900 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 2,903 | $ | 2,033 | |||||||
| Short-term contingent consideration | — | 4,103 | |||||||||
| Accrued expenses and other current liabilities | 4,375 | 3,436 | |||||||||
| Total current liabilities | 7,278 | 9,572 | |||||||||
| Long-term debt | 14,321 | 13,429 | |||||||||
| Long-term operating lease liabilities | 394 | 321 | |||||||||
| Long-term contingent consideration | 56,691 | 53,603 | |||||||||
| Deferred tax liabilities | 4,963 | 5,304 | |||||||||
| Other long-term liabilities | 685 | 587 | |||||||||
| Total liabilities | 84,332 | 82,816 | |||||||||
| Stockholders’ equity: | |||||||||||
Preferred stock, $0.001 par value, 10,000,000 authorized, no shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively. | — | — | |||||||||
Common stock, $0.001 par value, 100,000,000 shares authorized, 44,001,643 and 42,973,215 issued and outstanding as of December 31, 2024 and December 31, 2023, respectively. | 44 | 43 | |||||||||
| Additional paid in capital | 406,609 | 401,638 | |||||||||
| Accumulated other comprehensive income (loss) | (35) | 3,047 | |||||||||
| Accumulated deficit | (376,472) | (319,644) | |||||||||
| Total stockholders’ equity | 30,146 | 85,084 | |||||||||
| Total liabilities and stockholders’ equity | $ | 114,478 | $ | 167,900 | |||||||
QUINCE THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
| Years Ended December 31, | |||||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 18,590 | $ | 9,447 | |||||||||||||||||||
| General and administrative | 17,580 | 17,695 | |||||||||||||||||||||
| Goodwill impairment charge | 17,130 | — | |||||||||||||||||||||
| Intangible asset impairment charge | — | 5,900 | |||||||||||||||||||||
| Fair value adjustment for contingent consideration | 3,985 | 1,578 | |||||||||||||||||||||
Total operating expenses (1) | 57,285 | 34,620 | |||||||||||||||||||||
| Loss from operations | (57,285) | (34,620) | |||||||||||||||||||||
| Fair value adjustment for long-term debt | (1,709) | (338) | |||||||||||||||||||||
| Interest income | 2,929 | 3,478 | |||||||||||||||||||||
| Other expense, net | (676) | (102) | |||||||||||||||||||||
| Net loss before income tax (expense) benefit | (56,741) | (31,582) | |||||||||||||||||||||
| Income tax (expense) benefit | (87) | 197 | |||||||||||||||||||||
| Net loss | (56,828) | (31,385) | |||||||||||||||||||||
| Net loss per share - basic and diluted | $ | (1.31) | $ | (0.84) | |||||||||||||||||||
| Weighted average shares of common stock outstanding - basic and diluted | 43,262,269 | 37,237,149 | |||||||||||||||||||||
(1) Expenses include the following amount of non-cash stock-based compensation expense.
| Years Ended December 31, | |||||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| General and administrative expense | $ | 3,876 | $ | 4,003 | |||||||||||||||||||
| Research and development expense | 870 | 1,217 | |||||||||||||||||||||
| Total stock-based compensation | $ | 4,746 | $ | 5,220 | |||||||||||||||||||