Financial Performance - The company reported a net loss of $13.4 million for the three months ended September 30, 2025, compared to a net loss of $5.5 million for the same period in 2024, representing a 145% increase in net loss [176]. - The company recorded a net loss of $44.5 million for the nine months ended September 30, 2025, compared to a net loss of $44.4 million for the same period in 2024 [188]. - The accumulated deficit as of September 30, 2025, was $421.0 million, with net losses incurred since inception [202]. - The company has not generated any revenue and has financed operations primarily through the issuance of securities, raising approximately $320.1 million to date [201]. Research and Development - Research and development expenses increased to $8.1 million for the three months ended September 30, 2025, up from $4.9 million in the same period in 2024, marking a 64% increase [178]. - The development costs for eDSP rose by $3.0 million compared to the prior year, primarily due to increased clinical trial costs associated with the Phase 3 NEAT clinical trial [179]. - Research and development expenses increased by 78% to $22.8 million for the nine months ended September 30, 2025, compared to $12.8 million for the same period in 2024 [188]. - The costs for eDSP development rose by $8.2 million, primarily due to increased clinical trial costs of $7.2 million [190]. - The company completed enrollment of 105 participants in the Phase 3 NEAT clinical trial, with 83 participants in the primary analysis population, achieving approximately 90% power for statistical significance [156]. - The company expects to report topline results from the Phase 3 NEAT clinical trial in Q1 2026 and plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, assuming positive results [157]. - The company plans to expand its development pipeline to include additional indications for eDSP, with Duchenne Muscular Dystrophy (DMD) identified as the second targeted indication [161]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $13.4 million, a 129% increase from $5.9 million in the same period in 2024 [176]. - General and administrative expenses decreased by $0.3 million to $3.3 million for the three months ended September 30, 2025, compared to $3.6 million in 2024, reflecting a 10% decrease [181]. - General and administrative expenses decreased by 14% to $11.4 million for the nine months ended September 30, 2025, down from $13.3 million in 2024 [193]. - The company recorded accrued expenses of approximately $5.1 million for clinical trial and operational services as of September 30, 2025 [225]. Cash and Financing Activities - The company has $26.3 million in cash, cash equivalents, and short-term investments as of September 30, 2025, expected to fund operations into Q2 2026 [162]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $26.3 million, which may not be sufficient to fund operations for the next twelve months [203]. - The company utilized its ATM program to raise net proceeds of approximately $4.3 million by issuing 3,637,334 shares of common stock during the nine months ended September 30, 2025 [212]. - The company raised approximately $11.5 million in a private placement by issuing 6,671,928 shares of common stock and warrants [213]. - Cash provided by financing activities totaled $15.9 million for the nine months ended September 30, 2025, including $11.4 million from the June 2025 private placement [222]. Debt and Contingent Considerations - As of September 30, 2025, the company has an outstanding principal of €10.0 million ($11.7 million) on the EIB Loan, classified as current debt [215]. - The EIB Loan has a maximum borrowing capacity of €30.0 million, with tranches A and B drawn as of the reporting date [214]. - The fair value of the EIB Loan is $17.5 million, classified as current debt on the balance sheet [225]. - The fair value of long-term contingent consideration related to the EryDel acquisition is $61.2 million as of September 30, 2025 [225]. - A fair value adjustment for contingent consideration resulted in a $4.7 million increase for the three months ended September 30, 2025, primarily due to the passage of time [182]. - A fair value adjustment for contingent consideration resulted in a $2.4 million charge for the nine months ended September 30, 2025 [195]. Cash Flow Activities - Net cash used in operating activities increased by $6.6 million to $30.9 million for the nine months ended September 30, 2025, primarily due to higher clinical development costs [219]. - Cash provided by investing activities was $15.2 million for the nine months ended September 30, 2025, mainly from short-term investment maturities [221]. - The company has approximately $22.9 million in cancellable future operating expense commitments based on existing contracts as of September 30, 2025 [225].

Financial Performance - Quince Therapeutics reported cash, cash equivalents, and short-term investments of $26.3 million for Q3 2025, with an expected cash runway sufficient to fund operations through Q2 2026[11]. - The company reported a net loss of $13.3 million, or $0.25 per share, for Q3 2025, with weighted average shares outstanding of 54.0 million[11]. - The net loss for Q3 2025 was $13,442 million, compared to a net loss of $5,492 million in Q3 2024, reflecting a year-over-year increase of 144.5%[17]. - The company reported a net loss per share of $0.25 for Q3 2025, compared to $0.13 for Q3 2024[17]. - The total comprehensive loss for the nine months ended September 30, 2025, was $38,193 million, compared to $43,998 million for the same period in 2024[17]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $8.1 million, primarily related to the ongoing Phase 3 NEAT clinical trial activities[11]. - Research and development expenses for Q3 2025 were $8,083 million, a significant increase of 64.5% compared to $4,916 million in Q3 2024[17]. - Quince completed enrollment in the pivotal Phase 3 NEAT clinical trial with 105 participants, expecting topline results in Q1 2026[4]. - The NEAT clinical trial is powered at approximately 90% to detect a statistically significant difference between eDSP and placebo[3]. - Quince plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, assuming positive study results[4]. - The company has received FDA Fast Track designation for its eDSP System, addressing a high unmet medical need in A-T[4]. Operating Expenses - General and administrative (G&A) expenses for Q3 2025 totaled $3.3 million, including personnel-related costs and commercial planning expenses[11]. - Total operating expenses for Q3 2025 reached $13,430 million, up 128.5% from $5,863 million in Q3 2024[17]. - General and administrative expenses for Q3 2025 were $3,281 million, a decrease of 9.6% from $3,630 million in Q3 2024[17]. Liabilities and Equity - Quince's total liabilities increased to $108.8 million as of September 30, 2025, compared to $84.3 million at the end of 2024[15]. - The weighted average shares of common stock outstanding for Q3 2025 were 53,951,371, compared to 43,164,136 in Q3 2024[17]. Other Financial Metrics - Fair value adjustments for contingent consideration resulted in a charge of $2,066 million in Q3 2025, compared to a gain of $2,683 million in Q3 2024[17]. - Interest income for Q3 2025 was $300 million, down from $683 million in Q3 2024, representing a decline of 56.1%[17]. - 100% of NEAT participants have opted to transition to the open label extension study, indicating strong patient engagement[4]. - Total stock-based compensation for the nine months ended September 30, 2025, was $3,914 million, an increase of 8.1% from $3,621 million in the same period of 2024[18].

Overview of Quince Therapeutics - Quince Therapeutics is conducting its first Investor Day to present an overview of the company, its technology, development plans, and key investment highlights [1] - The presentation will include insights from various departmental and technical experts on the technology and its applications [2] Technology and Development Plans - The presentation will cover previous clinical studies and the development plan for the company's products [2] - New data on the mechanism of action of encapsulated dexamethasone will be discussed, highlighting its significance [2] Regulatory and Commercial Planning - The company will outline elements of its regulatory plan and provide details on commercial planning for post-approval activities [3] - A strong team with expertise in various functional areas will support the presentation and discussions [3]

Quince Therapeutics Investor Day Summary Company Overview - **Company**: Quince Therapeutics (NasdaqGS:QNCX) - **Event**: 2025 Investor Day held on October 02, 2025 - **Technology**: Autologous intracellular drug encapsulation (AID) technology, which allows encapsulation of drugs into a patient's own red blood cells for reinfusion [3][4][6] Key Highlights - **Current Status**: Quince is in Phase III clinical trials for ataxia telangiectasia (AT), having completed enrollment of 105 patients, with 83 in the primary analysis population [4][5][71] - **Lead Indication**: Ataxia telangiectasia is a rare pediatric genetic disease with no currently approved therapies, presenting a significant commercial opportunity [4][39][57] - **Partnership**: Recently announced a partnership with Option Care, an outpatient infusion network in the U.S. with approximately 170 locations, to support commercial planning post-approval [6] Clinical Development - **Phase III Trial**: The NEAT trial is designed to evaluate the efficacy of encapsulated dexamethasone in treating AT, with results expected in 2026 [4][71][82] - **Previous Studies**: The ATTEST study, which was the largest trial for AT, had a p-value of 0.07, indicating a near miss for statistical significance, but showed promising results in younger patients [58][63][67] - **Safety Profile**: No major safety concerns were reported in previous trials, with no instances of adrenal suppression or steroid toxicity [67][68] Mechanism of Action - **Dexamethasone Sodium Phosphate**: The lead drug, encapsulated in red blood cells, is designed to provide sustained release while minimizing toxicity associated with traditional corticosteroid administration [12][88] - **RNA Sequencing**: Recent RNA sequencing studies revealed significant gene dysregulation in AT patients, with over 6,000 genes differentially expressed, providing insights into the disease biology and potential biomarkers for treatment response [92][95] Market Opportunity - **Rare Diseases**: If successful in AT, Quince plans to pursue additional rare diseases, with Duchenne muscular dystrophy (DMD) as a primary target [5][22] - **Commercial Strategy**: The company is already planning for commercialization despite not having Phase III results yet, indicating confidence in the trial outcomes [6][7] Additional Insights - **Patient Experience**: The technology allows for a patient-friendly experience, with a fully automated process that takes about 90 minutes for drug encapsulation [33][34] - **Advocacy Groups**: Strong relationships with advocacy groups like the AT Children's Project and the AT Society are in place to support patient recruitment and awareness [78][80] Conclusion Quince Therapeutics is positioned to make significant advancements in the treatment of ataxia telangiectasia and potentially other rare diseases through its innovative drug delivery technology. The upcoming results from the NEAT trial in 2026 will be pivotal for the company's future and its ability to address unmet medical needs in rare pediatric conditions [82][88]

Unlocking the power of a patient's own biology for the treatment of rare disease Investor Day October 2, 2025 Welcome Dirk Thye, M.D. Chief Executive Officer & Chief Medical Officer Quince investor day agenda | 10:00 a.m. ET | Welcome, agenda, introductions | Dirk Thye | | --- | --- | --- | | 10:05 a.m. ET | Quince overview and key investment highlights | Dirk Thye | | 10:20 a.m. ET | Overview of innovative eDSP System | Giovanni Mambrini | | 10:30 a.m. ET | eDSP lead indication: A-T and Phase 3 NEAT study ...

Company Overview - Quince Therapeutics focuses on developing treatments for rare diseases [2] Leadership - The event features key executives from Quince Therapeutics, including CEO Dirk Thye and COO Brendan Hannah [1]

Core Insights - K-pop is a significant export industry for South Korea, contributing to approximately half of the auto exports, which totaled 68.3 billion USD last year [1] - The Chinese market has been largely absent from the K-pop scene due to a de facto ban on Korean wave products, including K-pop music, for the past decade [2] - The ban inadvertently pushed K-pop companies to explore markets beyond China, such as Europe and North America, leading to a global expansion of K-pop [3] Industry Dynamics - SM Entertainment's CEO acknowledges the importance of the Chinese market due to its proximity and large K-pop fandom, but also raises concerns about the evolving preferences of Chinese fans as local pop music gains popularity [4] - The universal appeal of music as an art form is emphasized, suggesting that K-pop can resonate with audiences regardless of language barriers [5] - K-pop is described as a strong and evolving genre, with continuous efforts from artists and industry professionals to enhance the quality of music and content [5]

Core Points - Quince Therapeutics, Inc. is a late-stage biotechnology company focused on utilizing a patient's own biology to treat rare diseases [1] - The company will host a virtual Investor Day on October 2, 2025, from 10:00 a.m. to 12:00 p.m. Eastern Time [1] - Presentations during the Investor Day will be led by the company's leadership team, highlighting the latest in clinical development and corporate updates [1]

Summary of Quince Therapeutics Conference Call Company Overview - **Company Name**: Quince Therapeutics - **Technology**: Autologous Intracellular Drug Encapsulation (AIDE) technology for encapsulating corticosteroids into patients' own red blood cells [2][3] Industry Context - **Focus Area**: Rare diseases, specifically targeting conditions like ataxia telangiectasia and Duchenne muscular dystrophy (DMD) [3][4] - **Market Opportunity**: The rare disease market is estimated to exceed $1 billion for ataxia telangiectasia alone [3] Core Points and Arguments - **Current Development Stage**: Quince is in Phase 3 trials for ataxia telangiectasia, having completed enrollment with 83 patients in the primary analysis population and 105 overall [3][5] - **Commercial Strategy**: Partnership with Option Care Health, which has approximately 170 outpatient infusion sites, to facilitate product distribution [5][19] - **Safety Profile**: Strong safety database with 70 patients showing no adrenal suppression over three years of monthly treatment [12] - **Efficacy Mechanism**: AIDE technology allows for chronic corticosteroid therapy without the typical toxicities associated with long-term use [2][9] Key Data and Milestones - **Phase 3 Data Readout**: Expected in Q1 2026, which will be pivotal for determining the efficacy of the treatment [5][21] - **Regulatory Pathway**: The study protocol is under special protocol assessment with the FDA, allowing for a single pivotal trial to support approval [17] - **Market Size**: Approximately 10,000 addressable patients in the U.S. and Europe for ataxia telangiectasia, with potential for over $1 billion in revenue [18][19] Additional Insights - **Future Indications**: Plans to pursue additional indications for corticosteroid therapy, including DMD, after raising further capital post-Phase 3 results [20][21] - **Epidemiological Research**: Identified around 4,600 patients with confirmed ataxia telangiectasia in the U.S., supporting market potential [19] - **Device Approval**: The AIDE device has a CE mark in Europe but is regulated differently in the U.S. as a drug-device combination [18] Conclusion Quince Therapeutics is positioned to make significant advancements in the treatment of rare diseases through its innovative AIDE technology, with a strong focus on safety and efficacy, backed by strategic partnerships and a clear regulatory pathway. The upcoming Phase 3 data readout will be crucial for the company's future trajectory and market entry.

[Front Matter](index=1&type=section&id=Front%20Matter) This section contains preliminary information about the Form 10-Q filing, forward-looking statements, and defined terms [Form 10-Q Filing Information](index=1&type=section&id=Form%2010-Q%20Filing%20Information) This Form 10-Q for Quince Therapeutics, Inc. covers Q2 2025, reporting 53.7 million shares outstanding - Quince Therapeutics, Inc. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) | Indicator | Value | | :--- | :--- | | Filer Status | Non-accelerated filer, Smaller reporting company | | Common Stock Outstanding (as of Aug 5, 2025) | 53,713,798 shares | | Trading Symbol | QNCX | | Exchange | The Nasdaq Stock Market LLC | [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements subject to known and unknown risks and uncertainties detailed in 'Risk Factors' - The report contains forward-looking statements regarding future results, business strategy, drug candidates, clinical trials, regulatory approvals, and financial performance[9](index=9&type=chunk)[10](index=10&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and assumptions, including those described in the 'Risk Factors' section[10](index=10&type=chunk) - Readers are cautioned not to rely on forward-looking statements as predictions of future events, and the company does not intend to update them unless legally required[12](index=12&type=chunk) [Defined Terms](index=6&type=section&id=Defined%20Terms) This section defines key abbreviated and specific terms used in the Quarterly Report on Form 10-Q - The section defines key terms such as AIDE (Autologous Intracellular Drug Encapsulation), eDSP (Encapsulated dexamethasone sodium phosphate), A-T (Ataxia-Telangiectasia), and various financial and regulatory acronyms[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk) [PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Quince Therapeutics' unaudited condensed consolidated financial statements and explanatory notes [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets slightly increased to $117.21 million, while liabilities grew significantly due to warrants and long-term debt | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $16,826 | $6,212 | $10,614 | 170.86% | | Short-term investments | $17,882 | $34,572 | $(16,690) | (48.28)% | | Total current assets | $37,345 | $44,036 | $(6,691) | (15.19)% | | Intangible assets | $67,566 | $60,045 | $7,521 | 12.53% | | Total assets | $117,210 | $114,478 | $2,732 | 2.39% | | Total current liabilities | $7,467 | $7,278 | $189 | 2.60% | | Long-term debt | $16,989 | $14,321 | $2,668 | 18.63% | | Warrant liabilities | $15,144 | $0 | $15,144 | N/A | | Total liabilities | $105,474 | $84,332 | $21,142 | 25.07% | | Total stockholders' equity | $11,736 | $30,146 | $(18,410) | (61.07)% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss improved to $16.05 million (3 months) and $31.08 million (6 months), mainly due to no goodwill impairment | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $6,553 | $4,147 | $2,406 | 58.02% | | General and administrative | $3,342 | $4,695 | $(1,353) | (28.82)% | | Goodwill impairment charge | $0 | $17,130 | $(17,130) | (100.00)% | | Fair value adjustment for contingent consideration | $532 | $2,220 | $(1,688) | (76.04)% | | Total operating expenses | $10,427 | $28,192 | $(17,765) | (62.99)% | | Net loss | $(16,049) | $(27,729) | $11,680 | (42.12)% | | Net loss per share (basic and diluted) | $(0.34) | $(0.64) | $0.30 | (46.88)% | | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Research and development | $14,698 | $7,849 | $6,849 | 87.26% | | General and administrative | $8,131 | $9,666 | $(1,535) | (15.88)% | | Goodwill impairment charge | $0 | $17,130 | $(17,130) | (100.00)% | | Fair value adjustment for contingent consideration | $2,456 | $4,765 | $(2,309) | (48.46)% | | Total operating expenses | $25,285 | $39,410 | $(14,125) | (35.84)% | | Net loss | $(31,079) | $(38,878) | $7,799 | (20.06)% | | Net loss per share (basic and diluted) | $(0.69) | $(0.90) | $0.21 | (23.33)% | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $11.74 million, driven by net loss, partially offset by equity and warrant issuances | Metric (in thousands) | December 31, 2024 | June 30, 2025 | Change ($) | Change (%) | | :-------------------- | :---------------- | :------------ | :--------- | :--------- | | Common Stock (shares) | 44,001,643 | 53,624,180 | 9,622,537 | 21.87% | | Common Stock (value) | $44 | $53 | $9 | 20.45% | | Additional paid in capital | $406,609 | $413,078 | $6,469 | 1.59% | | Accumulated other comprehensive income (loss) | $(35) | $6,156 | $6,191 | N/A | | Accumulated deficit | $(376,472) | $(407,551) | $(31,079) | 8.26% | | Total stockholders' equity | $30,146 | $11,736 | $(18,410) | (61.07)% | - Issuance of common stock and warrants in private placement generated **$746 thousand** in additional paid-in capital[32](index=32&type=chunk) - Issuance of common stock in ATM offerings generated **$2.89 million** in additional paid-in capital[32](index=32&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by $10.61 million, driven by financing and investing activities, offsetting operating cash outflows | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(21,016) | $(17,092) | $(3,924) | 22.96% | | Net cash provided by investing activities | $16,937 | $3,936 | $13,001 | 330.33% | | Net cash provided by financing activities | $14,499 | $225 | $14,274 | 6344.00% | | Net increase (decrease) in cash and cash equivalents | $10,