Quince Therapeutics(QNCX) - 2025 Q2 - Quarterly Results

Executive Summary & Q2 2025 Highlights Quince Therapeutics achieved key milestones in Q2 2025, including completing Phase 3 NEAT trial enrollment, securing financing, and forming a commercial partnership for eDSP Second Quarter 2025 Key Achievements Quince Therapeutics achieved significant milestones over the last quarter, including completing enrollment for the pivotal Phase 3 NEAT clinical trial, securing additional financing to extend its operating runway, and establishing a strategic partnership with Option Care Health for the commercial launch of its lead asset, eDSP - Completed enrollment in the pivotal Phase 3 NEAT clinical trial evaluating eDSP for the treatment of Ataxia-Telangiectasia (A-T)[2][4][5] - Secured approximately $11.5 million in upfront proceeds from a private placement, extending the existing cash position to approximately $35 million, expected to provide runway through Phase 3 topline results and into at least Q2 2026[2][4][9] - Entered into a strategic relationship with Option Care Health to support the commercial launch of eDSP in the U.S.[2][4][9] - Topline results from the Phase 3 NEAT clinical trial are expected in the first quarter of 2026, with a subsequent New Drug Application (NDA) submission planned for the second half of 2026, assuming positive study results[2][4][5] Clinical Development & Pipeline Updates This section details the progress of the pivotal Phase 3 NEAT clinical trial, other pipeline advancements, and corporate strategic developments Pivotal Phase 3 NEAT Clinical Trial Quince Therapeutics successfully completed enrollment for its pivotal Phase 3 NEAT clinical trial for A-T, enrolling 105 participants, with the primary analysis population achieving approximately 90% statistical power - Enrollment completed with a total of 105 participants, including 83 in the six to nine year-old primary analysis population and 22 participants aged 10 years and older[5] - The 83 enrolled participants in the primary analysis population reflect powering of approximately 90% to determine statistical significance of the primary endpoint[5] - Topline results are expected in Q1 2026, and assuming positive study results, the company plans to submit an NDA to the FDA in H2 2026[5] - The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA, and eDSP was granted FDA Fast Track designation for A-T[5] - All 50 NEAT participants to date have elected to transition to the open label extension (OLE) study[5] - NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating eDSP (dexamethasone sodium phosphate encapsulated in autologous red blood cells) in A-T patients[5] - 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[6] Other Pipeline and Corporate Updates Beyond the NEAT trial, Quince Therapeutics advanced its pipeline and corporate strategy by forming a key commercial partnership, securing additional financing, progressing eDSP development for Duchenne muscular dystrophy (DMD) and a pediatric A-T study, and strengthening its Scientific Advisory Board Strategic Partnerships & Financing Quince Therapeutics established a strategic commercial partnership with Option Care Health and secured approximately $11.5 million in upfront proceeds from a private placement - Announced a strategic relationship with Option Care Health, Inc. to support the commercial development and efficient launch of eDSP in the U.S., leveraging their network for administration[9] Private Placement Financing (June 2025) | Item | Details | | :--- | :--- | | Upfront Proceeds | ~$11.5 million | | Potential Additional Proceeds (warrant exercise) | Up to $10.4 million | | Pricing | >10% premium to market price of common stock | | Lead Investor | Nantahala Capital | | Participants | Existing stockholders (ADAR1 Capital Management, Legend Capital Partners, Lagfin S.C.A.), new stockholder (Second Line Capital), Quince senior management | Other Clinical & Corporate Developments Quince Therapeutics progressed eDSP development for Duchenne muscular dystrophy (DMD) and a pediatric A-T study, and strengthened its Scientific Advisory Board - Finalized Phase 2 clinical trial study designs to evaluate eDSP for the potential treatment of Duchenne muscular dystrophy (DMD), prioritizing capital-efficient approaches including potential investigator-initiated trials (IITs)[9] - Initiated Study 3 (Pediatric Encapsulated Dexamethasone Sodium Phosphate, PeD study) in the European Union pediatric investigational plan to evaluate the safety and pharmacokinetics of eDSP in younger A-T patients (9-15 kilograms)[9] - Participated at the 2025 A-T Clinical Research Conference, where key opinion leaders presented post hoc data analyses from the prior Phase 3 ATTeST clinical trial, and Quince management provided an overview of the Phase 3 NEAT clinical trial[9] - Appointed Dr. Hassan Abolhassani to the company's Scientific Advisory Board (SAB), becoming the ninth member and adding expertise in clinical immunology[9] Second Quarter 2025 Financial Results This section presents Quince Therapeutics' financial performance for Q2 2025, including cash position, operating expenses, net loss, and balance sheet changes Financial Highlights Quince Therapeutics reported a cash, cash equivalents, and short-term investments balance of $34.7 million as of June 30, 2025, providing an expected cash runway into Q2 2026, potentially extending into H2 2026 with full warrant exercise Key Financial Highlights (Q2 2025) | Metric | Value (in millions) | | :--- | :--- | | Cash, cash equivalents, and short-term investments (as of June 30, 2025) | $34.7 | | Research and development (R&D) expenses (Q2 2025) | $6.6 | | General and administrative (G&A) expenses (Q2 2025) | $3.3 | | Net loss (Q2 2025) | $16.1 | | Net loss per basic and diluted share (Q2 2025) | $0.34 | | Net cash used in operating activities (Six months ended June 30, 2025) | $21.0 | - Existing cash runway is expected to be sufficient to fund the company's capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. Full exercise of warrants could extend the cash runway into the second half of 2026[9] - R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs[9] - G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning, new product planning expenses, and other professional administrative costs[10] Condensed Consolidated Balance Sheets As of June 30, 2025, Quince Therapeutics reported total assets of $117.2 million, a slight increase from $114.5 million at December 31, 2024, while total liabilities significantly increased to $105.5 million, primarily driven by warrant liabilities Condensed Consolidated Balance Sheets (Selected Items, in thousands) | Item | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $16,826 | $6,212 | +$10,614 | | Short-term investments | $17,882 | $34,572 | -$16,690 | | Total current assets | $37,345 | $44,036 | -$6,691 | | Intangible assets | $67,566 | $60,045 | +$7,521 | | Total assets | $117,210 | $114,478 | +$2,732 | | Total current liabilities | $7,467 | $7,278 | +$189 | | Long-term debt | $16,989 | $14,321 | +$2,668 | | Warrant liabilities | $15,144 | $0 | +$15,144 | | Total liabilities | $105,474 | $84,332 | +$21,142 | | Total stockholders' equity | $11,736 | $30,146 | -$18,410 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the second quarter ended June 30, 2025, Quince Therapeutics reported a net loss of $16.0 million, an improvement from $27.7 million in Q2 2024, primarily due to the absence of a goodwill impairment charge Condensed Consolidated Statements of Operations (Selected Items, in thousands) | Item | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,553 | $4,147 | $14,698 | $7,849 | | General and administrative | $3,342 | $4,695 | $8,131 | $9,666 | | Goodwill impairment charge | $0 | $17,130 | $0 | $17,130 | | Fair value adjustment for contingent consideration | $532 | $2,220 | $2,456 | $4,765 | | Fair value adjustment for warrants | $4,464 | $0 | $4,464 | $0 | | Net loss | $(16,049) | $(27,729) | $(31,079) | $(38,878) | | Net loss per share - basic and diluted | $(0.34) | $(0.64) | $(0.69) | $(0.90) | - Research and development expenses increased by $2.4 million (58.0%) for Q2 2025 year-over-year and by $6.8 million (86.6%) for the six months ended June 30, 2025, primarily due to ongoing Phase 3 NEAT clinical trial activities and manufacturing costs[9][17] - General and administrative expenses decreased by $1.3 million (28.8%) for Q2 2025 year-over-year and by $1.5 million (15.9%) for the six months ended June 30, 2025, mainly due to lower personnel-related and stock-based compensation expenses[10][17] - The net loss improved significantly in Q2 2025 compared to Q2 2024, largely due to the absence of a $17.1 million goodwill impairment charge recorded in the prior year period[17] Company Information & Disclaimers This section provides an overview of Quince Therapeutics, outlines forward-looking statements, and lists contact information for media and investors About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to developing treatments for rare diseases by leveraging a patient's own biology - Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company[11] - The company is dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases[11] Forward-looking Statements This section contains forward-looking statements, as defined by the Private Securities Litigation Reform Act of 1995, regarding clinical trial timelines, financial outlook, eDSP development, strategic partnerships, and regulatory submissions - Statements in this news release are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995[12] - Examples include statements relating to the timing, success, and reporting of clinical trial results (e.g., Phase 3 NEAT topline results, NDA submission), expected cash position and operating runway, current and future clinical development of eDSP (A-T, DMD), strategic development path (Option Care Health partnership), and market opportunity[12] - Forward-looking statements are based on current expectations and are subject to inherent uncertainties, risks, and assumptions that could cause actual results to differ materially, as described in the company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC[12] Media & Investor Contact Contact information for media and investor inquiries is provided, directing communications to Stacy Roughan, Vice President, Corporate Communications & Investor Relations for Quince Therapeutics, Inc. - Media & Investor Contact: Stacy Roughan, Vice President, Corporate Communications & Investor Relations, Quince Therapeutics, Inc.[13] - Email for inquiries: ir@quincetx.com[13]