[Executive Summary & Q2 2025 Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Q2%202025%20Highlights) 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](index=1&type=section&id=Second%20Quarter%202025%20Key%20Achievements) 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](index=2&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - 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](index=2&type=chunk)[4](index=4&type=chunk)[9](index=9&type=chunk) - Entered into a strategic relationship with Option Care Health to support the commercial launch of eDSP in the U.S.[2](index=2&type=chunk)[4](index=4&type=chunk)[9](index=9&type=chunk) - 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](index=2&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) [Clinical Development & Pipeline Updates](index=1&type=section&id=Clinical%20Development%20%26%20Pipeline%20Updates) 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](index=1&type=section&id=Pivotal%20Phase%203%20NEAT%20Clinical%20Trial) 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](index=5&type=chunk) - The **83** enrolled participants in the primary analysis population reflect powering of approximately **90%** to determine statistical significance of the primary endpoint[5](index=5&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) - All **50** NEAT participants to date have elected to transition to the open label extension (OLE) study[5](index=5&type=chunk) - 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](index=5&type=chunk) - 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](index=6&type=chunk) [Other Pipeline and Corporate Updates](index=2&type=section&id=Pipeline%20and%20Corporate%20Updates) 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](index=2&type=section&id=Strategic%20Partnerships%20%26%20Financing) 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](index=9&type=chunk) 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](index=2&type=section&id=Other%20Clinical%20%26%20Corporate%20Developments) 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](index=9&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) - Appointed Dr. Hassan Abolhassani to the company's Scientific Advisory Board (SAB), becoming the **ninth member** and adding expertise in clinical immunology[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section presents Quince Therapeutics' financial performance for Q2 2025, including cash position, operating expenses, net loss, and balance sheet changes [Financial Highlights](index=2&type=section&id=Financial%20Highlights) 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](index=9&type=chunk) - R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs[9](index=9&type=chunk) - G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning, new product planning expenses, and other professional administrative costs[10](index=10&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) 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](index=9&type=chunk)[17](index=17&type=chunk) - 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](index=10&type=chunk)[17](index=17&type=chunk) - 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](index=17&type=chunk) [Company Information & Disclaimers](index=4&type=section&id=Company%20Information%20%26%20Disclaimers) This section provides an overview of Quince Therapeutics, outlines forward-looking statements, and lists contact information for media and investors [About Quince Therapeutics](index=4&type=section&id=About%20Quince%20Therapeutics) 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](index=11&type=chunk) - The company is dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases[11](index=11&type=chunk) [Forward-looking Statements](index=4&type=section&id=Forward-looking%20Statements) 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) [Media & Investor Contact](index=4&type=section&id=Media%20%26%20Investor%20Contact) 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](index=13&type=chunk) - Email for inquiries: ir@quincetx.com[13](index=13&type=chunk)

eDSP & A-T - eDSP (Red blood cell encapsulated dexamethasone sodium phosphate) is designed to chronically deliver corticosteroid efficacy without toxicity[5] - The company is conducting a Pivotal Phase 3 NEAT clinical trial in pediatric rare disease Ataxia-Telangiectasia (A-T) with no currently approved treatments and a $1+ billion commercial opportunity[9] - 99 patients with A-T enrolled as of June 25, 2025, including 78 participants in 6 to 9 year-old cohort[9, 46] - The estimated prevalence of A-T is approximately 10,000 patients in the U S, U K, and EU4 countries[28, 53] - The company plans to submit NDA with FDA and MAA with EMA in 2026[49] Financials - The company recently closed up to $22 million private placement of securities – with proceeds of approximately $11.5 million upfront and up to $10.4 million if warrants exercised in full[9] - Financing proceeds plus $31.6 million in cash provides funding through topline results in first quarter of 2026 and into the second quarter of 2026 – or second half of 2026 if warrants exercised[9] - The company has invested $100 million in AIDE technology over 20+ years of research & development[13, 76] Pipeline Expansion - The company sees significant pipeline expansion opportunity for eDSP with Duchenne muscular dystrophy (DMD) as second indication with multiple other rare immunology and autoimmune focused rare disease targets[9, 56, 60] - The company plans to dose first patient in DMD Phase 2 clinical study in 2026[60, 64] AIDE Technology - 20+ years of research & development and $100 million invested in AIDE technology[13, 76]

Group 1 - Quince Therapeutics (QNCX) is focused on developing treatments for ataxia-telangiectasia, a rare neurodegenerative disorder that begins in early childhood [1] - The company has been previously covered in the summer of 2024, indicating ongoing interest and analysis in its stock performance [1] - The stock has shown positive performance, suggesting potential investor interest and market confidence [1] Group 2 - The analyst has a beneficial long position in QNCX shares, indicating personal investment and confidence in the company's future [2] - The article reflects the analyst's own opinions and is not influenced by external compensation, suggesting an independent analysis [2]

Financial Performance - The net loss for the three months ended March 31, 2025, was $15.0 million, representing a 35% increase from a net loss of $11.1 million in the same period in 2024[142]. - Total operating expenses for the three months ended March 31, 2025, were $14.9 million, a 32% increase from $11.2 million in the same period in 2024[142]. - Cash used in operating activities for Q1 2025 was $9.6 million, primarily due to a net loss of $15.0 million[167]. - Interest income decreased by 54% to $406,000 for the three months ended March 31, 2025, compared to $887,000 for the same period in 2024[150]. - As of March 31, 2025, the company had an accumulated deficit of $391.5 million[154]. Research and Development - Research and development expenses increased by 120% to $8.1 million for the three months ended March 31, 2025, compared to $3.7 million for the same period in 2024[142]. - The development costs for eDSP rose by $3.4 million, primarily due to clinical trial costs of $6.2 million[144]. - The company anticipates needing to raise substantial additional capital for drug development and operations, influenced by various factors including trial progress and regulatory approvals[159]. - Enrollment for the Phase 3 NEAT clinical trial may conclude early by the end of June 2025, with a target of 86 patients in the primary analysis population[130]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $31.6 million as of March 31, 2025, which is insufficient to fund operations for the next twelve months[155]. - The company expects existing cash, cash equivalents, and investments to fund operations through early 2026, pending additional program costs[157]. - Cash provided by investing activities was $10.9 million for Q1 2025, mainly from short-term investment maturities[169]. - The company entered into a Controlled Equity Offering Sales Agreement to sell up to $21.9 million of common stock, with $2.9 million raised through its ATM program[161]. Debt and Commitments - As of March 31, 2025, the company had outstanding principal of €10.0 million ($10.8 million) on the EIB Loan, recorded as long-term debt[162]. - The EIB Loan includes four tranches, with maximum borrowings of €30.0 million, and only tranches A and B have been drawn as of March 31, 2025[162]. - The company has approximately $22.8 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2025[172]. - The company recorded accrued expenses of approximately $5.3 million for vendor expenditures as of March 31, 2025[172]. Market Opportunities - The global market for A-T is estimated to represent a peak commercial opportunity of over $1 billion[128]. - The company plans to submit applications for approval in the U.S. and Europe in the second half of 2026, assuming positive results from the NEAT study[130].

Financial Performance - Quince Therapeutics reported cash, cash equivalents, and short-term investments of $31.6 million for Q1 2025, sufficient to fund operations through early 2026[6]. - The company reported a net loss of $15.0 million for Q1 2025, equating to a net loss of $0.34 per share, with 43.9 million shares outstanding[6]. - Total operating expenses for Q1 2025 were $14.9 million, compared to $11.2 million in Q1 2024, reflecting increased R&D costs[13]. - Quince's total assets decreased from $114.5 million at the end of 2024 to $107.1 million by March 31, 2025[11]. Research and Development - Research and development expenses for Q1 2025 were $8.1 million, primarily related to the Phase 3 NEAT clinical trial[6]. - A total of 63 participants have been enrolled in the Phase 3 NEAT clinical trial, with an early enrollment conclusion potentially by the end of June 2025[4]. - The NEAT trial aims to achieve approximately 80% power to determine a statistically significant difference in the primary endpoint if enrollment concludes early[3]. - The company experienced slower than anticipated enrollment due to a challenging academic site environment, but expects increased screening and randomization activities soon[4]. Future Plans - Quince plans to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application (MAA) in Europe in the second half of 2026, assuming positive trial results[4]. - The company has activated all 19 study sites for the NEAT trial, including new sites in the U.K. and Europe[4].

Summary of Quince Therapeutics Conference Call Company Overview - **Company Name**: Quince Therapeutics - **Focus**: Development of therapies for rare diseases using autologous red blood cells to encapsulate drugs [3][4] Industry Context - **Industry**: Rare Disease Drug Development - **Market Opportunity**: High unmet need in rare diseases, particularly with no approved therapies for conditions like ataxia telangiectasia [1][5] Core Points and Arguments - **Lead Drug**: Encapsulated dexamethasone sodium phosphate, currently in Phase III trials with 60% patient enrollment [4][5] - **Indication**: Ataxia telangiectasia, a rare genetic disease affecting approximately 5,000 patients in the US, with no approved therapies available [5][12] - **Trial Design**: Placebo-controlled trial focusing on younger patients (ages 6-9) who are deteriorating rapidly, aiming for a significant effect size [15][16] - **Safety Profile**: Previous studies showed no steroid toxicity in patients treated for over 13 years, supporting the safety of chronic steroid use via this method [11][16] - **Financial Position**: Cash runway projected into 2026, allowing for continued development and data collection [5][18] Key Data and Metrics - **Efficacy Measurement**: Primary endpoint is based on the ICARS scale, focusing on gait and posture, with a historical effect size of 28% difference relative to placebo over six months [39][38] - **Market Size**: Estimated annual therapy pricing between $400,000 to $700,000, leading to a potential billion-dollar market for this indication alone [16][17] - **Patient Population**: Approximately 10,000 patients diagnosed with ataxia telangiectasia across the US and Europe [16] Additional Insights - **Technology Background**: The encapsulation technology was developed over 20 years with significant investment, allowing for a unique delivery method that mitigates steroid toxicity [6][34] - **Potential for Expansion**: The platform could be adapted for other steroids or therapies, broadening the scope beyond rare diseases [17][18] - **Regulatory Pathway**: The trial is under a special protocol assessment with the FDA, indicating a streamlined path to potential approval if positive results are achieved [15][38] Conclusion Quince Therapeutics is positioned to address a significant unmet need in the rare disease space with its innovative drug delivery system. The ongoing Phase III trial for ataxia telangiectasia represents a critical step towards potential market entry, supported by a strong safety profile and a substantial market opportunity.

Market Opportunity - The global market for A-T treatments represents a peak commercial opportunity of over $1 billion[507]. - A-T patient population in the U.S. is estimated to be approximately 4,600 based on third-party analysis[519]. Clinical Trials - The Phase 3 NEAT clinical trial for eDSP has enrolled 60 participants as of March 24, 2025, with topline results expected in Q4 2025[508]. - The company initiated the Phase 3 NEAT clinical trial in June 2024 and plans to start a Phase 2 clinical trial for DMD in 2025[510]. - The company received Fast Track designation from the FDA for the eDSP System for A-T treatment in June 2024[510]. - The company paid a cash milestone payment of $5 million to former EryDel shareholders upon enrolling the first patient in the Phase 3 NEAT clinical trial[655]. Financial Performance - The company incurred a net loss of $56.8 million in 2024, compared to a net loss of $31.4 million in 2023, representing an 81% increase in losses[550]. - Cash, cash equivalents, and short-term investments decreased to $40.8 million as of December 31, 2024, down from $75.1 million in 2023[551]. - The company has an accumulated deficit of $376.5 million as of December 31, 2024, indicating ongoing financial challenges[550]. - The company reported total operating expenses of $57.3 million for 2024, an increase of approximately 65.3% from $34.6 million in 2023[590]. - The company recorded a net loss of $56.8 million for the year ended December 31, 2024, which included non-cash items totaling $25.4 million[564]. - The company reported total liabilities of $71.012 million as of December 31, 2024, which included $56.691 million in contingent consideration and $14.321 million in long-term debt[653]. Research and Development - Research and development expenses increased by 97% to $18.6 million in 2024 from $9.4 million in 2023, primarily due to costs associated with the Phase 3 NEAT clinical trial[537]. - The company expects research and development expenses to remain at current levels as it continues the Phase 3 NEAT clinical trial and expands into new indications[518]. - Research and development expenses primarily consist of personnel costs and are expensed as incurred, with significant variability in payment flows due to contracts with third-party service providers[633]. Funding and Capital Needs - The company anticipates needing additional funding to support operations and development efforts, with substantial doubt about its ability to continue as a going concern within the next year[551]. - The Company anticipates that its cash and cash equivalents balance as of December 31, 2024, will not be sufficient to fund operations and capital expenditures for at least the next twelve months, necessitating additional funding[602]. - Management expects to incur additional losses in the future to fund operations and may need to raise additional capital through equity securities or debt financings[606]. Asset and Liability Management - As of December 31, 2024, the company reported total assets of $114.5 million, a decrease from $167.9 million in 2023, reflecting a decline of approximately 31.8%[589]. - The company has a contingent consideration balance of $56.7 million as of December 31, 2024, with a change in fair value of $4.0 million for the year[584]. - The fair value adjustment for contingent consideration increased by $4.0 million in 2024, primarily due to changes in probability assessments related to achieving various milestones[544]. Goodwill and Impairment - The company recognized a non-cash goodwill impairment charge of $17.1 million during 2024[532]. - A non-cash goodwill impairment charge of $17.1 million was recorded in 2024, reflecting a significant decline in market capitalization since the acquisition of EryDel[542]. Stock and Equity - The Company has authorized the issuance of 100 million shares of common stock, with 44,001,643 shares issued and outstanding as of December 31, 2024[691]. - The Company operates three stock plans, with a total of 16,171,478 shares reserved for future issuance as of December 31, 2024[691]. - The Company has not declared any dividends on common stock since its inception[691]. Debt and Loans - The company guaranteed an EIB Loan of up to €30.0 million, with only tranches A (€3.0 million) and B (€7.0 million) drawn as of December 31, 2024[559][560]. - The EIB Loan bears fixed interest rates ranging from 7.0% to 9.0% per annum, with a principal amount of €10.0 million ($10.4 million) outstanding as of December 31, 2024[560]. - The Company became a guarantor of the EIB Loan, with a maximum borrowing capacity of €30 million, of which €10 million ($10.4 million) was outstanding as of December 31, 2024[680]. Miscellaneous - The Company operates as one reportable segment focused on developing and commercializing its proprietary AIDE technology platform[614]. - The Company adopted ASU 2023-07 during the year ended December 31, 2024, which requires public entities to disclose significant expenses and other segment items on an interim and annual basis[642].

Clinical Trials - The Phase 3 NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized, targeting completion in Q2 2025[2] - The NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the FDA, with topline results expected in Q4 2025[5] - Quince plans to initiate a Phase 2 study for Duchenne muscular dystrophy (DMD) in 2025[4] Financial Performance - The company reported a net loss of $56.8 million, or $1.31 per share, for the fiscal year ended December 31, 2024, compared to a net loss of $31.4 million in 2023[10] - Quince reported cash, cash equivalents, and short-term investments of $40.8 million as of December 31, 2024, expected to fund operations through Phase 3 topline results into 2026[9] - Quince's total liabilities as of December 31, 2024, were $84.3 million, compared to $82.8 million in 2023[15] Expenses - Research and development (R&D) expenses for FY 2024 were $18.6 million, primarily related to the ongoing Phase 3 NEAT clinical trial activities[9] - General and administrative (G&A) expenses for FY 2024 totaled $17.6 million, including personnel-related and stock-based compensation expenses[9] Future Plans - The company expects to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in 2026, assuming positive study results[5] - A cash milestone payment of $5.0 million was made to EryDel shareholders in Q3 2024 following the enrollment of the first patient in the NEAT study[10]

Clinical Trials and Development - As of November 13, 2024, 32 patients have been enrolled in the Phase 3 NEAT clinical trial of EryDex for A-T, with topline results expected in Q4 2025 and a potential NDA submission in 2026[156]. - The Phase 3 NEAT clinical trial is conducted under an SPA agreement with the U.S. FDA, allowing for NDA submission upon positive results[174]. - EryDex has received Fast Track designation from the FDA, facilitating frequent interactions with review staff and eligibility for priority review[174]. - The company plans to initiate a Phase 2 clinical trial for EryDex targeting Duchenne muscular dystrophy (DMD) in 2025, focusing on patients with corticosteroid intolerance[165]. - The number of patients with any treatment-emergent adverse events (TEAEs) was 82% in the high dose EryDex group compared to 73% in the placebo group[183]. - The primary efficacy endpoint of the ATTeST trial was missed by the high dose EryDex group with a p-value of 0.077, but statistical significance was observed in the per protocol analysis with a p-value of 0.019[179]. Financial Performance - Research and development expenses increased by 244% to $4.9 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023[194]. - EryDex development costs rose by $3.2 million in the three months ended September 30, 2024, primarily due to clinical trial costs of $2.9 million and $0.3 million in manufacturing costs[196]. - General and administrative expenses decreased by $1.03 million to $3.63 million for the three months ended September 30, 2024, from $4.66 million for the same period in 2023[199]. - A fair value adjustment for contingent consideration resulted in a $2.7 million charge for the three months ended September 30, 2024, related to the EryDel Acquisition[200]. - Interest income decreased by $276,000 for the three months ended September 30, 2024, due to decreased yields on the investment portfolio[202]. - The net loss for the three months ended September 30, 2024, was $5.49 million, compared to a net loss of $5.35 million for the same period in 2023, representing a 3% increase in loss[194]. - Total operating expenses decreased by 4% to $5.86 million for the three months ended September 30, 2024, from $6.09 million for the same period in 2023[194]. - The company incurred a net loss of $44.4 million for the nine months ended September 30, 2024, compared to a net loss of $22.5 million for the same period in 2023, representing a 97% increase in losses[220]. - As of September 30, 2024, the company had an accumulated deficit of $364.0 million[220]. - The company has not generated any revenue to date and does not expect to do so until it obtains marketing approval for a drug candidate[220]. Cash Flow and Capital Needs - Cash, cash equivalents, and short-term investments totaled $47.8 million as of September 30, 2024, down from $75.1 million at the end of 2023[227]. - The company believes its existing cash and investments will be sufficient to fund operations into the first quarter of 2026, excluding costs for additional programs[228]. - Cash used in operating activities for the nine months ended September 30, 2024, was $24.4 million, compared to $12.2 million for the same period in 2023, reflecting a net loss of $44.4 million in 2024[236][237]. - Cash provided by investing activities was $11.0 million for the nine months ended September 30, 2024, primarily from maturities of short-term investments of $100.7 million[238]. - Cash used in financing activities was $4.8 million for the nine months ended September 30, 2024, which included a cash milestone payment of $5 million[239]. - The company anticipates needing to raise substantial additional capital following the acquisition of EryDel, influenced by the progress and costs of the Phase 3 NEAT clinical trial[231]. - The company may face challenges in raising additional capital due to potential worsening global economic conditions and market volatility[234]. Technology and Market Potential - The global market for A-T treatments is estimated to exceed $1 billion, with approximately 4,600 diagnosed patients in the U.S. and no approved treatments currently available[158]. - The AIDE technology platform has been developed over 20 years with an investment of approximately $100 million, creating high barriers to competitive entry[167]. - EryDex is designed to alter the pharmacokinetics and biodistribution of DSP, a corticosteroid, to provide effective and safe treatment for A-T[155][167]. - The AIDE technology platform may be applied to a broad range of drugs, with potential indications including autoimmune hepatitis, dermatomyositis, and pediatric lupus among others[166]. - The RCL and EryKit are CE marked medical devices, ensuring compliance with EU regulations for the AIDE technology[160][176]. Expenses and Impairments - Research and development expenses increased by 112% to $12.8 million for the nine months ended September 30, 2024, compared to $6.0 million for the same period in 2023[205]. - The increase in research and development expenses was primarily driven by EryDex development costs, which rose by $8.9 million due to Phase 3 NEAT clinical trial costs of $8.1 million[207]. - General and administrative expenses rose by $0.5 million to $13.3 million for the nine months ended September 30, 2024, mainly due to a $1.9 million increase in personnel-related expenses[211]. - A non-cash goodwill impairment charge of $17.1 million was recorded for the nine months ended September 30, 2024, due to deteriorating macro-economic conditions and a decline in market capitalization[214]. - Cash used in operating activities was primarily due to non-cash items totaling $22.4 million, including a $17.1 million goodwill impairment charge[236].

Clinical Trials - Quince Therapeutics has enrolled 32 patients in the Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T), with plans to enroll approximately 86 patients aged six to nine years and 20 patients aged 10 years or older[2][3]. - The company expects to complete enrollment in the second quarter of 2025 and report topline results in the fourth quarter of 2025, with NDA and MAA submissions planned for 2026, assuming positive study results[5]. - Quince plans to initiate a Phase 2 clinical trial for EryDex in Duchenne muscular dystrophy (DMD) in 2025, targeting patients with corticosteroid intolerance[9][10]. Financial Performance - Quince reported a net loss of $5.5 million, or $0.13 per share, for the third quarter of 2024, with weighted average shares outstanding of 43.2 million[11]. - The company reported cash, cash equivalents, and short-term investments of $47.8 million as of September 30, 2024, which is expected to fund operations through the Phase 3 NEAT topline results and into 2026[11]. - The total assets of Quince Therapeutics decreased from $167.9 million as of December 31, 2023, to $126.5 million as of September 30, 2024[15][16]. Research and Development Expenses - Research and development (R&D) expenses for the third quarter of 2024 were $4.9 million, primarily related to the ongoing Phase 3 NEAT clinical trial[11]. - Research and development expenses for Q3 2024 were $338 million, down from $386 million in Q3 2023, a decrease of about 12.4%[18]. General and Administrative Expenses - Quince's general and administrative (G&A) expenses for the third quarter of 2024 were $3.6 million, which included personnel-related and stock-based compensation expenses[11]. - General and administrative expenses for Q3 2024 were $786 million, compared to $945 million in Q3 2023, reflecting a decrease of approximately 16.8%[18]. Stock-Based Compensation - Total stock-based compensation for Q3 2024 was $1,124 million, compared to $1,331 million in Q3 2023, representing a decline of approximately 15.6%[18]. - For the nine months ended September 30, 2024, total stock-based compensation was $3,621 million, down from $4,134 million for the same period in 2023, a decrease of about 12.4%[18]. Milestones and Payments - The company made a cash milestone payment of $5 million to EryDel shareholders in the third quarter of 2024 following the enrollment of the first patient in the NEAT study[12]. - The company has identified additional potential rare disease indications for EryDex, including autoimmune hepatitis and dermatomyositis, among others[10].