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].

Company Overview - Quince Therapeutics (NASDAQ:QNCX) is a biotech company focused on developing treatments for rare diseases, with a primary asset being EryDex, a drug delivery platform for Ataxia-Telangiectasia [2][3] - The company aims to expand its development pipeline through in-licensing and acquisition of clinical-stage assets, following a strategic shift after previous setbacks in Alzheimer's disease [3] EryDex and AIDE Technology - EryDex utilizes the AIDE technology platform, which allows for the encapsulation of drugs into a patient's red blood cells, enabling continuous delivery of dexamethasone sodium phosphate over a month without toxicity [2][4] - The treatment involves harvesting about 50 ml of the patient's blood, loading it with dexamethasone, and reinfusing it back into the patient [4] Ataxia-Telangiectasia - Ataxia-Telangiectasia is a genetic disorder with approximately 10,000 diagnosed patients in the U.S., U.K., and Big 4 EU countries, and no approved treatment currently exists [2][6] - The disease is characterized by poor coordination and dilated blood vessels, leading to severe disability and a median lifespan of 25-30 years [6] Clinical Trials and Results - Quince is conducting a pivotal Phase 3 trial (NEAT) for EryDex, targeting patients aged 6-9, with topline data expected in Q4 2025 [2][15] - Previous Phase 3 trials (ATTeST) showed statistically significant efficacy in the 6-9 year old subgroup, with a notable 4.8-point improvement on the mICARS rating scale compared to placebo [10][11] Market Potential - The peak commercial potential for EryDex in treating Ataxia-Telangiectasia is estimated to exceed $1 billion, assuming a treatment price similar to other orphan drugs [21][22] - The company anticipates a market entry as early as 2027, with potential for high market penetration due to the lack of competing treatments [22][28] Financials - As of June 2024, Quince had $59 million in cash, expected to fund operations into 2026, with a net loss of $27.7 million reported for the last quarter [24] - The company is currently trading below its cash value, indicating a potentially undervalued position in the market [23][27] Leadership - Quince's leadership team has extensive experience, with CEO Dirk Thye having a successful track record in founding and selling companies, as well as obtaining FDA approvals [20] - Insider buying activity has been noted, with significant purchases by leadership, indicating confidence in the company's future [20]

Product Development - Quince Therapeutics is focused on developing EryDex, a treatment for A-T, with the first patient enrolled in the Phase 3 NEAT clinical trial in Q2 2024, expecting topline results in Q4 2025 and potential NDA submission in 2026[129][142]. - EryDex has received Fast Track designation from the FDA, highlighting its potential to address a high unmet medical need for A-T patients[130][144]. - The Phase 3 NEAT trial aims to enroll about 86 patients aged 6-9 and 20 patients aged 10 and older, with a primary efficacy endpoint based on changes in RmICARS scores[143][144]. - The NEAT trial is conducted under an SPA agreement with the FDA, facilitating NDA submission upon positive results[144]. - EryDex's development is supported by insights gained from the prior ATTeST Phase 3 trial, which involved 176 patients and highlighted the importance of early treatment in A-T[146]. - EryDex is classified as a drug/device combination product by the FDA, with plans to submit a 505(b)(2) NDA in 2026, leveraging prior findings of safety and effectiveness for the active ingredient, DSP[145]. - Quince Therapeutics plans to initiate a proof-of-concept study for EryDex in Duchenne muscular dystrophy (DMD) in 2025, targeting corticosteroid intolerance in this population[138]. - The company intends to explore additional indications for EryDex in various rare diseases where chronic corticosteroid treatment is standard but limited by safety concerns[139]. Market Opportunity - The updated patient sizing project indicates approximately 4,600 diagnosed A-T patients in the U.S. as of July 2024, up from previous estimates of 3,400, with a global market opportunity exceeding $1 billion[131]. - The AIDE technology platform, which encapsulates drugs in patients' red blood cells, has been developed over 20 years with an investment of approximately $100 million, creating high barriers to entry for competitors[140]. Financial Performance - Research and development expenses increased by 207% to $4.2 million for the three months ended June 30, 2024, compared to $1.4 million for the same period in 2023[160]. - Total operating expenses rose by 405% to $28.2 million for the three months ended June 30, 2024, compared to $5.6 million for the same period in 2023[160]. - The net loss for the three months ended June 30, 2024, was $27.7 million, a 468% increase compared to a net loss of $4.9 million for the same period in 2023[160]. - Research and development expenses increased by $3.3 million, reaching $7.8 million for the six months ended June 30, 2024, compared to $4.6 million for the same period in 2023, representing a 71% increase[173]. - The net loss for the six months ended June 30, 2024, was $38.9 million, compared to a net loss of $17.1 million for the same period in 2023, marking a 127% increase in losses[185]. - The company recorded a non-cash goodwill impairment charge of $17.1 million for the six months ended June 30, 2024, due to deteriorating macro-economic conditions and a decline in market capitalization[179]. - General and administrative expenses rose by $1.6 million to $9.7 million for the six months ended June 30, 2024, primarily driven by increased personnel-related expenses[176]. - Cash used in operating activities was $17.1 million for the six months ended June 30, 2024, compared to $7.4 million for the same period in 2023, reflecting a significant increase in operational losses[195][196]. - The company had an accumulated deficit of $358.5 million as of June 30, 2024, reflecting ongoing financial challenges since inception[185]. Cash Flow and Capital Resources - Cash, cash equivalents, and short-term investments totaled $59.4 million as of June 30, 2024, down from $75.1 million at the end of 2023[188]. - The company expects existing capital resources to be sufficient to fund projected operating requirements for at least the next twelve months[188]. - The company anticipates needing to raise substantial additional capital following the acquisition of EryDel, influenced by various factors including clinical trial progress and regulatory approvals[191]. - The company’s existing cash, cash equivalents, and investments are expected to fund planned operations, including clinical activities related to EryDex, through 2026[193]. - The EIB Loan, assumed during the acquisition of EryDel, has a maximum borrowing capacity of €30 million, with only tranches A and B drawn as of June 30, 2024[186]. - Cash provided by investing activities was $3.9 million for the six months ended June 30, 2024, primarily from the maturities of short-term investments[197]. - Cash provided by financing activities was $0.2 million for the six months ended June 30, 2024, from the exercise of stock options[197]. - The net increase in cash and cash equivalents for the six months ended June 30, 2024, was $(12.9) million, compared to $(21.9) million for the same period in 2023[194]. - The company has approximately $29.6 million in cancellable future operating expense commitments based on existing contracts as of June 30, 2024[200]. Clinical Trial Results - EryDex high dose missed the primary efficacy endpoint with a p-value of 0.077, but showed statistical significance in the per protocol analysis with a p-value of 0.019[148]. - Patients with any treatment-emergent adverse events (TEAE) in the EryDex high dose group were 82%, compared to 73% in the placebo group[152].

Financial Performance - Quince reported a net loss of $27.7 million for Q2 2024, including a non-cash goodwill impairment charge of $17.1 million[6]. - The company reported a net loss of $27,729,000 for Q2 2024, compared to a net loss of $4,886,000 in Q2 2023, reflecting a 466% increase in losses[11]. - The net loss per share for Q2 2024 was $(0.64), compared to $(0.14) in Q2 2023[11]. - Total operating expenses for Q2 2024 were $28,192,000, a significant increase from $5,584,000 in Q2 2023, representing a 404% rise[11]. - Research and development expenses for Q2 2024 were $4,147,000, up from $1,353,000 in Q2 2023, indicating a 206% increase[11]. - General and administrative expenses for Q2 2024 totaled $4.7 million, including personnel-related costs and commercial planning[6]. - Total stock-based compensation for Q2 2024 was $1,223,000, slightly down from $1,321,000 in Q2 2023[11]. - Interest income for Q2 2024 was $823,000, compared to $805,000 in Q2 2023, a modest increase of 2%[11]. - Fair value adjustment for contingent consideration in Q2 2024 was $2,220,000, with no such adjustment in Q2 2023[11]. - The company incurred a fair value adjustment for long-term debt of $(415,000) in Q2 2024, with no such expense in Q2 2023[11]. Clinical Trials and Research - The company achieved a major milestone by enrolling the first patient in the Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T), with a target of approximately 86 patients aged 6 to 9 years[2]. - The NEAT trial is a randomized, double-blind, placebo-controlled study evaluating EryDex's neurological effects, with topline results expected in Q4 2025[3]. - The company plans to initiate a proof-of-concept study for Duchenne muscular dystrophy (DMD) in 2025, focusing on capital-efficient study approaches[5]. - Research and development expenses for Q2 2024 were $4.2 million, primarily related to the NEAT clinical trial[6]. Market Opportunity - The estimated number of diagnosed A-T patients in the U.S. has increased to approximately 4,600, representing a global market opportunity exceeding $1 billion[4]. Financial Position - Quince Therapeutics reported cash, cash equivalents, and short-term investments of $59.4 million for Q2 2024, expected to fund operations through 2026[6]. - Quince's total assets decreased to $134.8 million as of June 30, 2024, down from $167.9 million at the end of 2023[9]. Strategic Initiatives - The company is evaluating potential strategic partnerships to extend operational runway and support NDA approval for EryDex in the U.S.[5].

Product Development - Quince Therapeutics is focused on developing EryDex, a treatment for A-T, with a global market opportunity exceeding $1 billion [145]. - The Phase 3 NEAT clinical trial for EryDex is expected to begin enrollment in Q2 2024, targeting approximately 86 patients aged 6 to 9 and 20 patients aged 10 and older [161]. - EryDex has received orphan drug designation from the U.S. FDA and EU EC for the treatment of A-T [163]. - The previous ATTeST Phase 3 trial involved 176 patients and evaluated two doses of EryDex, with a primary efficacy endpoint based on neurological symptoms measured by mICARS [166]. - The company plans to submit a New Drug Application (NDA) to the FDA in 2026, contingent on positive NEAT trial results [162]. - EryDex is designed to improve the pharmacokinetics and biodistribution of DSP, a corticosteroid, to enhance safety and efficacy [156]. - The company aims to explore additional indications for EryDex in rare diseases where corticosteroid treatment is standard but limited by safety concerns [154]. - The NEAT trial will be conducted under a Special Protocol Assessment (SPA) agreement with the FDA, facilitating NDA submission post-trial [162]. Financial Performance - Research and development expenses increased by 14.6% to $3.7 million for the three months ended March 31, 2024, compared to $3.2 million for the same period in 2023 [185]. - EryDex development costs rose by $2.7 million due to Phase 3 NEAT clinical trial start-up costs, primarily from a $2.4 million increase in clinical trial costs [186]. - General and administrative expenses increased by 29.9% to $5.0 million for the three months ended March 31, 2024, from $3.8 million for the same period in 2023 [190]. - A fair value adjustment for contingent consideration resulted in a $2.5 million charge for the three months ended March 31, 2024, related to the EryDel acquisition [191]. - Interest income increased by 26.7% to $0.887 million for the three months ended March 31, 2024, compared to $0.700 million for the same period in 2023 [185]. - The net loss for the three months ended March 31, 2024, was $11.149 million, a decrease of 9.0% from a net loss of $12.254 million for the same period in 2023 [185]. - No intangible asset impairment charges were recognized during the three months ended March 31, 2024, compared to a $5.9 million charge in the same period of 2023 [193]. - The company anticipates a significant increase in research and development expenses as it prepares to begin enrollment for the Phase 3 NEAT clinical trial [177]. - Personnel-related costs decreased by $0.4 million during the three months ended March 31, 2024, compared to the same period in 2023 [188]. - As of March 31, 2024, the company had an accumulated deficit of $330.8 million and incurred a net loss of $11.1 million for the three months ended March 31, 2024 [198]. Funding and Cash Flow - The company has financed operations through the issuance of convertible promissory notes and redeemable convertible preferred stock, receiving net proceeds of approximately $303.9 million since inception [199]. - Cash, cash equivalents, and short-term investments were $67.8 million as of March 31, 2024, down from $75.1 million as of December 31, 2023 [200]. - The company believes existing capital resources will fund operations into at least 2026, excluding costs associated with in-licensing activities [201]. - Substantial additional funding will be needed to support ongoing operations and development strategies, with potential reliance on equity or debt financing [202]. - Net cash used in operating activities was $8.4 million for the three months ended March 31, 2024, primarily due to the net loss [209]. - Cash provided by investing activities was $8.9 million for the three months ended March 31, 2024, mainly from maturities of short-term investments [211]. - Cash provided by financing activities was $0.2 million for the three months ended March 31, 2024, from the exercise of stock options [212]. - The fair value of long-term contingent consideration related to the EryDel acquisition is $60.3 million, with a short-term portion of $4.7 million as of March 31, 2024 [214]. - The company has approximately $14.3 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2024 [214].

[PART I](index=15&type=section&id=PART%20I) This section provides an overview of the company's business, strategic direction, associated risks, corporate governance, and operational details [Item 1. Business.](index=15&type=section&id=Item%201.%20Business.) Quince Therapeutics pivoted to rare diseases via EryDel acquisition, advancing AIDE platform and lead Phase 3 asset EryDex for A-T - Quince Therapeutics, Inc. (formerly Cortexyme, Inc.) completed the acquisition of **EryDel** on **October 20, 2023**, shifting its strategic focus to late-stage biotechnology for rare diseases, utilizing EryDel's proprietary **AIDE technology platform** and lead Phase 3 asset, **EryDex**[29](index=29&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - The **AIDE technology platform** is an innovative drug/device combination designed to encapsulate drugs into a patient's own red blood cells, offering potential benefits such as better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolonged circulating half-life[34](index=34&type=chunk)[40](index=40&type=chunk)[45](index=45&type=chunk) - **EryDex**, the lead asset, encapsulates **Dexamethasone Sodium Phosphate (DSP)** in red blood cells to treat **Ataxia-Telangiectasia (A-T)**, a rare neurodegenerative disease with no approved treatments, representing a potential **$1+ billion** peak commercial opportunity[37](index=37&type=chunk)[49](index=49&type=chunk)[52](index=52&type=chunk) - The company plans to initiate enrollment for the **Phase 3 NEAT clinical trial** of EryDex in A-T in **Q2 2024**, with top-line results anticipated in **H2 2025**, and aims for a U.S. **NDA submission in 2026**, contingent on positive study results[42](index=42&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - As of **December 31, 2023**, Quince had **$75.1 million** in cash, cash equivalents, and investments, providing capital into **2026** to fund the Phase 3 NEAT clinical trial and prepare for potential NDA submission[36](index=36&type=chunk)[485](index=485&type=chunk) - Key events in **Fiscal Year 2023** included the sale of the legacy small molecule protease inhibitor portfolio, a workforce reduction of approximately **47%** to align with the new corporate strategy, and the acquisition of **EryDel**[43](index=43&type=chunk) [Overview](index=15&type=section&id=Overview) [Strategy](index=15&type=section&id=Strategy) [Fiscal Year 2023 Key Events](index=17&type=section&id=Fiscal%20Year%202023%20Key%20Events) [Proprietary AIDE Technology Platform](index=17&type=section&id=Proprietary%20AIDE%20Technology%20Platform) [Phase 3 Lead Asset – EryDex for the Potential Treatment of A-T](index=21&type=section&id=Phase%203%20Lead%20Asset%20%E2%80%93%20EryDex%20for%20the%20Potential%20Treatment%20of%20A-T) [Prior ATTeST Phase 3 Clinical Trial Results in Patients with A-T](index=23&type=section&id=Prior%20ATTeST%20Phase%203%20Clinical%20Trial%20Results%20in%20Patients%20with%20A-T) [Pivotal Phase 3 NEAT Clinical Trial of EryDex in Patients with A-T](index=25&type=section&id=Pivotal%20Phase%203%20NEAT%20Clinical%20Trial%20of%20EryDex%20in%20Patients%20with%20A-T) [Regulatory Interactions](index=25&type=section&id=Regulatory%20Interactions) [Manufacturing](index=27&type=section&id=Manufacturing) [Commercialization Plan](index=27&type=section&id=Commercialization%20Plan) [Competition](index=27&type=section&id=Competition) [Intellectual Property](index=28&type=section&id=Intellectual%20Property) [Regulatory Matters](index=32&type=section&id=Regulatory%20Matters) [U.S. Drug Development](index=32&type=section&id=U.S.%20Drug%20Development) [EU Drug Development](index=43&type=section&id=EU%20Drug%20Development) [Combination Products](index=51&type=section&id=Combination%20Products) [Pharmaceutical Coverage, Pricing and Reimbursement](index=53&type=section&id=Pharmaceutical%20Coverage%2C%20Pricing%20and%20Reimbursement) [Healthcare Law and Regulation](index=55&type=section&id=Healthcare%20Law%20and%20Regulation) [Healthcare Reform](index=57&type=section&id=Healthcare%20Reform) [Employees and Human Capital](index=59&type=section&id=Employees%20and%20Human%20Capital) [Corporate Information](index=59&type=section&id=Corporate%20Information) [Item 1A. Risk Factors.](index=61&type=section&id=Item%201A.%20Risk%20Factors.) The company faces significant risks in EryDex development, integration, funding, regulatory compliance, and intellectual property protection - The success of the **EryDel Acquisition** and the realization of expected operational efficiencies and benefits are uncertain, with potential challenges in integration, retaining key employees, and managing increased costs[194](index=194&type=chunk)[195](index=195&type=chunk) - The company is substantially dependent on the success of its lead drug candidate, **EryDex**, for **A-T**. The previous **Phase 3 ATTeST trial** failed its primary endpoint, and there is no guarantee the upcoming **NEAT study** will be successful or lead to NDA approval[196](index=196&type=chunk)[197](index=197&type=chunk)[201](index=201&type=chunk) - The company has never generated revenue from sales, has incurred net losses since inception (**$31.4 million in 2023**, **$51.7 million in 2022**), and expects to continue incurring losses, requiring substantial additional funding[198](index=198&type=chunk)[200](index=200&type=chunk)[230](index=230&type=chunk) - Milestone payments of up to **$485.0 million** to EryDel shareholders and obligations under the EIB Facility could impose substantial additional costs and adversely affect EryDex's profitability if approved[204](index=204&type=chunk)[205](index=205&type=chunk) - Clinical drug development is lengthy, expensive, and uncertain; preclinical and early clinical trial results are not always predictive of future outcomes, and drug candidates may not achieve favorable results or receive marketing approval[213](index=213&type=chunk)[214](index=214&type=chunk) - The company's ability to obtain and maintain sufficient **intellectual property protection** for its drug candidates and technology is critical, as competitors could develop similar products, and patent challenges are costly and uncertain[354](index=354&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) - The company is subject to extensive government regulations (**FDA**, **EMA**) for drug development, manufacturing, and marketing. Non-compliance or changes in regulations could lead to delays, penalties, or inability to commercialize products[88](index=88&type=chunk)[90](index=90&type=chunk)[342](index=342&type=chunk) - Healthcare reforms, including the **PPACA** and **IRA**, aim to contain costs and may negatively impact drug pricing, coverage, and reimbursement, potentially limiting revenue and profitability for approved products[178](index=178&type=chunk)[180](index=180&type=chunk)[182](index=182&type=chunk) [Risks Relating to Our Business](index=61&type=section&id=Risks%20Relating%20to%20Our%20Business) [Risks Related to the Development of Our Drug Candidates](index=65&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Drug%20Candidates) [Risks Relating to Our Financial Position](index=71&type=section&id=Risks%20Relating%20to%20Our%20Financial%20Position) [Risks Relating to Regulatory Review and Approval of Our Drug Candidates and Other Legal Compliance Matters](index=77&type=section&id=Risks%20Relating%20to%20Regulatory%20Review%20and%20Approval%20of%20Our%20Drug%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) [Risks Relating to Our Intellectual Property](index=117&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) [General Risk Factors](index=141&type=section&id=General%20Risk%20Factors) [Item 1B. Unresolved Staff Comments.](index=149&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company has no unresolved staff comments from the SEC - There are no unresolved staff comments[458](index=458&type=chunk) [Item 1C. Cybersecurity.](index=151&type=section&id=Item%201C.%20Cybersecurity.) Quince Therapeutics maintains a structured cybersecurity risk management program, overseen by the Audit Committee, integrating threat identification and mitigation - The board of directors' **Audit Committee** oversees the company's cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats[459](index=459&type=chunk)[466](index=466&type=chunk) - The company implements various information security processes, including manual and automated tools, threat reports, systems monitoring, personnel training, cybersecurity insurance, data encryption, and access controls, to identify, assess, and manage material cybersecurity risks[460](index=460&type=chunk)[461](index=461&type=chunk)[462](index=462&type=chunk) - Cybersecurity risk management is **integrated** into the company's overall risk management processes, with the IT Department and senior management prioritizing and mitigating threats[463](index=463&type=chunk)[467](index=467&type=chunk) - The company utilizes **third-party service providers** for cybersecurity assistance and employs a vendor management strategy to address risks associated with these providers[464](index=464&type=chunk) [Cybersecurity Risk Management and Strategy](index=151&type=section&id=Cybersecurity%20Risk%20Management%20and%20Strategy) [Governance](index=151&type=section&id=Governance) [Item 2. Properties.](index=153&type=section&id=Item%202.%20Properties.) Quince Therapeutics operates headquarters in South San Francisco, a manufacturing facility in Medolla, Italy, and an office in Bresso, Italy - The company's corporate headquarters are in **South San Francisco, California**, with a lease expiring in **November 2024**[469](index=469&type=chunk) - Manufacturing operations are located in **Medolla, Italy**, under a lease agreement expiring in **August 2028**[469](index=469&type=chunk) - An additional office space is leased in **Bresso, Italy**, with a lease agreement extending until **January 2036**[469](index=469&type=chunk) [Item 3. Legal Proceedings.](index=153&type=section&id=Item%203.%20Legal%20Proceedings.) The company is not currently involved in material legal proceedings, but future litigation could adversely impact its business and reputation - The company is **not currently a party** to any litigation or legal proceedings that are likely to have a material adverse effect on its business[470](index=470&type=chunk) - Litigation, regardless of outcome, can adversely impact the company due to defense and settlement costs, diversion of management resources, negative publicity, and reputational harm[470](index=470&type=chunk) [Item 4. Mine Safety Disclosures.](index=153&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company [PART II](index=154&type=section&id=PART%20II) This section details the company's common equity market, dividend policy, financial condition, results of operations, and market risk disclosures [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.](index=154&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) Quince Therapeutics' common stock trades on Nasdaq under 'QNCX', with 50 holders of record, and no cash dividends are declared or planned - The company's common stock is listed on the **Nasdaq Stock Market LLC** under the trading symbol "**QNCX**" since **August 1, 2022**, previously "**CRTX**" since **May 9, 2019**[3](index=3&type=chunk)[474](index=474&type=chunk) - As of **March 25, 2024**, there were **50 holders** of record of the company's common stock[5](index=5&type=chunk)[475](index=475&type=chunk) - The company has **never declared or paid any cash dividends** on its common stock and does not intend to in the foreseeable future, planning to retain all future earnings for business operations and general corporate purposes. The EIB Facility also prohibits dividend payments[442](index=442&type=chunk)[476](index=476&type=chunk) [Market Information](index=154&type=section&id=Market%20Information) [Stockholders](index=154&type=section&id=Stockholders) [Dividend Policy](index=154&type=section&id=Dividend%20Policy) [Sales of Unregistered Securities](index=154&type=section&id=Sales%20of%20Unregistered%20Securities) [Issuer Purchases of Equity Securities](index=154&type=section&id=Issuer%20Purchases%20of%20Equity%20Securities) [Item 6. Reserved.](index=154&type=section&id=Item%206.%20Reserved.) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=155&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Quince Therapeutics, now a rare disease biotech, reported a **$31.4 million net loss in 2023**, with **$75.1 million cash** to fund operations into **2026** - Quince Therapeutics is now a late-stage biotechnology company focused on rare diseases, leveraging its **AIDE technology platform** and lead asset **EryDex** for **Ataxia-Telangiectasia (A-T)**[479](index=479&type=chunk)[480](index=480&type=chunk)[481](index=481&type=chunk) - The company completed the acquisition of **EryDel** in **October 2023**, issuing **6,525,315 shares** of common stock and potentially up to **$485.0 million** in contingent cash payments based on development, NDA acceptance, approval, and sales milestones[484](index=484&type=chunk) Net Loss and Cash Position | Metric | 2023 (in millions) | 2022 (in millions) | Change (YoY) | | :-------------------------------- | :------------------ | :------------------ | :------------- | | Net Loss | $(31.4) | $(51.7) | $(20.3) decrease | | Accumulated Deficit (as of Dec 31) | $(319.6) | $(288.3) | $(31.3) increase | | Cash, Cash Equivalents & Investments (as of Dec 31) | $75.1 | $90.2 | $(15.1) decrease | - The company expects its existing capital resources of **$75.1 million** to fund planned operations, including the Phase 3 NEAT clinical trial for EryDex, into **2026**[485](index=485&type=chunk)[491](index=491&type=chunk)[552](index=552&type=chunk) Operating Expenses (in thousands) | Expense Category | 2023 | 2022 | Change ($) | Change (%) | | :----------------------------------- | :----- | :----- | :--------- | :--------- | | Research and development | $9,447 | $25,178 | $(15,731) | (62.5)% | | General and administrative | $17,695 | $26,012 | $(8,317) | (32.0)% | | Goodwill impairment charge | $0 | $825 | $(825) | (100.0)% | | Intangible asset impairment charge | $5,900 | $0 | $5,900 | 100.0% | | Fair value adjustment for contingent consideration | $1,578 | $0 | $1,578 | 100.0% | | **Total operating expenses** | **$34,620** | **$52,015** | **$(17,395)** | **(33.4)%** | - Research and development expenses decreased by **$15.7 million (62.5%)** in **2023**, primarily due to the completion of COR588 trials, out-licensing of legacy assets (COR388, COR588, NOV004), and reduced personnel costs, despite increased EryDex development costs[529](index=529&type=chunk)[530](index=530&type=chunk)[532](index=532&type=chunk)[533](index=533&type=chunk)[535](index=535&type=chunk) - General and administrative expenses decreased by **$8.3 million (32.0%)** in **2023**, mainly due to reduced personnel expenses (including stock-based compensation and headcount reduction) and lower corporate insurance, partially offset by increased business development consulting for the EryDel acquisition[537](index=537&type=chunk) Cash Flows Summary (in thousands) | Activity | 2023 | 2022 | | :-------------------------- | :------- | :------- | | Operating activities | $(18,292) | $(44,038) | | Investing activities | $(5,758) | $18,002 | | Financing activities | $143 | $707 | | Effect of exchange rate changes | $80 | $184 | | **Net decrease in cash** | **$(23,827)** | **$(25,145)** | [Overview](index=155&type=section&id=Overview) [2023 Events](index=155&type=section&id=2023%20Events) [Financial Overview](index=157&type=section&id=Financial%20Overview) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=159&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) [Research and Development Expenses](index=159&type=section&id=Research%20and%20Development%20Expenses) [Stock-Based Compensation Expense](index=161&type=section&id=Stock-Based%20Compensation%20Expense) [Income Taxes](index=161&type=section&id=Income%20Taxes) [Business Combination](index=163&type=section&id=Business%20Combination) [Goodwill](index=163&type=section&id=Goodwill) [Identifiable Intangible Assets](index=163&type=section&id=Identifiable%20Intangible%20Assets) [Impairment of Intangible Assets](index=165&type=section&id=Impairment%20of%20Intangible%20Assets) [Contingent Consideration](index=165&type=section&id=Contingent%20Consideration) [Long-term Debt](index=165&type=section&id=Long-term%20Debt) [Components of Operating Results](index=165&type=section&id=Components%20of%20Operating%20Results) [Research and Development Expenses](index=165&type=section&id=Research%20and%20Development%20Expenses) [General and Administrative Expenses](index=167&type=section&id=General%20and%20Administrative%20Expenses) [Interest Income](index=167&type=section&id=Interest%20Income) [Other Expense, net](index=167&type=section&id=Other%20Expense%2C%20net) [Results of Operations](index=167&type=section&id=Results%20of%20Operations) [Research and Development Expenses](index=169&type=section&id=Research%20and%20Development%20Expenses) [General and Administrative Expenses](index=170&type=section&id=General%20and%20Administrative%20Expenses) [Goodwill Impairment Charge](index=170&type=section&id=Goodwill%20Impairment%20Charge) [Intangible Asset Impairment Charge](index=170&type=section&id=Intangible%20Asset%20Impairment%20Charge) [Fair Value Adjustment for Contingent Consideration](index=170&type=section&id=Fair%20Value%20Adjustment%20for%20Contingent%20Consideration) [Fair Value Adjustment for Long-term Debt](index=170&type=section&id=Fair%20Value%20Adjustment%20for%20Long-term%20Debt) [Interest Income](index=170&type=section&id=Interest%20Income) [Other Expense](index=170&type=section&id=Other%20Expense) [Income Tax](index=170&type=section&id=Income%20Tax) [Liquidity, Capital Resources and Plan of Operations](index=172&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operations) [Capital Resources](index=172&type=section&id=Capital%20Resources) [Summary Statement of Cash Flows](index=174&type=section&id=Summary%20Statement%20of%20Cash%20Flows) [Operating Activities](index=174&type=section&id=Operating%20Activities) [Investing Activities](index=174&type=section&id=Investing%20Activities) [Financing Activities](index=174&type=section&id=Financing%20Activities) [Contractual Obligations and Commitments](index=176&type=section&id=Contractual%20Obligations%20and%20Commitments) [Recent Accounting Pronouncements](index=176&type=section&id=Recent%20Accounting%20Pronouncements) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk.](index=176&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Quince Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[564](index=564&type=chunk) [Item 8. Financial Statements and Supplementary Data.](index=177&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This section presents audited consolidated financial statements for 2023 and 2022, including balance sheets, income statements, cash flows, and notes, with auditor's opinion - The independent auditor, BDO USA, P.C., issued an **unqualified opinion** on the consolidated financial statements for the years ended **December 31, 2023 and 2022**, stating they present fairly the financial position and results of operations in conformity with **GAAP**[569](index=569&type=chunk) - A critical audit matter identified was the valuation of **contingent consideration** and **intangible assets** related to **In-process Research and Development (IPR&D)** from the **EryDel acquisition**, due to significant management judgment and subjectivity in determining fair values, probability rates, discount rates, and revenue projections[574](index=574&type=chunk)[575](index=575&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Metric | December 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------------ | :------------------ | | Total Assets | $167,900 | $103,910 | | Total Liabilities | $82,816 | $3,317 | | Total Stockholders' Equity | $85,084 | $100,593 | | Cash and cash equivalents | $20,752 | $44,579 | | Short-term investments | $54,307 | $45,602 | | Goodwill | $17,625 | $0 | | Intangible asset | $63,672 | $5,900 | | Long-term debt | $13,429 | $0 | | Long-term contingent consideration | $53,603 | $0 | Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--------------------------------------- | :---------------------- | :---------------------- | | Research and development expenses | $9,447 | $25,178 | | General and administrative expenses | $17,695 | $26,012 | | Intangible asset impairment charge | $5,900 | $0 | | Fair value adjustment for contingent consideration | $1,578 | $0 | | Loss from operations | $(34,620) | $(52,015) | | Interest income | $3,478 | $1,068 | | Net loss | $(31,385) | $(51,660) | | Net loss per share - basic and diluted | $(0.84) | $(1.54) | Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :-------------------------------- | :---------------------- | :---------------------- | | Net cash used in operating activities | $(18,292) | $(44,038) | | Net cash used in investing activities | $(5,758) | $18,002 | | Net cash provided by financing activities | $143 | $707 | | Net decrease in cash and cash equivalents | $(23,827) | $(25,145) | - The EryDel acquisition on **October 20, 2023**, involved a total consideration of approximately **$66.9 million**, including **$7.16 million** in common stock and **$56.1 million** in contingent consideration, leading to the recognition of **$61.1 million** in intangible assets (IPR&D) and **$16.9 million** in goodwill[744](index=744&type=chunk)[745](index=745&type=chunk)[746](index=746&type=chunk)[749](index=749&type=chunk)[750](index=750&type=chunk)[752](index=752&type=chunk) [Report of Independent Registered Public Accounting Firm](index=178&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) [Consolidated Balance Sheets](index=181&type=section&id=Consolidated%20Balance%20Sheets) [Consolidated Statements of Operations and Comprehensive Loss](index=182&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) [Consolidated Statements of Stockholders' Equity](index=183&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) [Consolidated Statements of Cash Flows](index=184&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Consolidated Financial Statements](index=186&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [Note 1. Organization](index=186&type=section&id=Note%201.%20Organization) [Note 2. Summary of Significant Accounting Policies](index=188&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) [Note 3. Fair Value Measurements](index=200&type=section&id=Note%203.%20Fair%20Value%20Measurements) [Note 4: Cash, Cash Equivalents and Investments](index=203&type=section&id=Note%204%3A%20Cash%2C%20Cash%20Equivalents%20and%20Investments) [Note 5: Balance Sheet Components](index=207&type=section&id=Note%205%3A%20Balance%20Sheet%20Components) [Note 6. Leases](index=211&type=section&id=Note%206.%20Leases) [Note 7. Long-term Debt](index=215&type=section&id=Note%207.%20Long-term%20Debt) [Note 8. Commitments and Contingencies](index=217&type=section&id=Note%208.%20Commitments%20and%20Contingencies) [Note 9. Equity Incentive Plans](index=217&type=section&id=Note%209.%20Equity%20Incentive%20Plans) [Note 10. Common Stock](index=226&type=section&id=Note%2010.%20Common%20Stock) [Note 11. Related Party Transactions](index=227&type=section&id=Note%2011.%20Related%20Party%20Transactions) [Note 12. Income taxes](index=227&type=section&id=Note%2012.%20Income%20taxes) [Note 13. Net Loss per Share](index=231&type=section&id=Note%2013.%20Net%20Loss%20per%20Share) [Note 14. Employee Benefit Plan](index=231&type=section&id=Note%2014.%20Employee%20Benefit%20Plan) [Note 15. Business Combination](index=231&type=section&id=Note%2015.%20Business%20Combination) [Note 16. Intangible Assets](index=237&type=section&id=Note%2016.%20Intangible%20Assets) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=240&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure for the company - There are no changes in or disagreements with accountants on accounting and financial disclosure[771](index=771&type=chunk) [Item 9A. Controls and Procedures](index=240&type=section&id=Item%209A.%20Controls%20and%20Procedures) Quince Therapeutics' management evaluated disclosure controls and internal control over financial reporting as effective, excluding the EryDel business from the 2023 assessment - As of **December 31, 2023**, the company's disclosure controls and procedures were evaluated as **effective**, designed to provide reasonable assurance for timely and accurate information disclosure[771](index=771&type=chunk) - Management assessed the effectiveness of internal control over financial reporting as of **December 31, 2023**, and concluded it was **effective**, using the **COSO framework**[773](index=773&type=chunk)[774](index=774&type=chunk) - The acquired **EryDel business** (representing approximately **$91.9 million** of total assets and **$4.0 million** of total operating loss) was excluded from the **2023 assessment** of internal control over financial reporting due to ongoing integration, as permitted by SEC Staff guidance[774](index=774&type=chunk) - There have been **no material changes** in internal control over financial reporting during the fourth quarter ended **December 31, 2023**[776](index=776&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=240&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) [Management's Report on Internal Control over Financial Reporting](index=240&type=section&id=Management%27s%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) [Changes in Internal Control over Financial Reporting](index=240&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) [Item 9B. Other Information](index=242&type=section&id=Item%209B.%20Other%20Information) This item reports that there is no other information required to be disclosed - No other information is required to be disclosed under this item[777](index=777&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=242&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company, indicating no foreign jurisdictions prevent inspections of its operations - This item is not applicable[777](index=777&type=chunk) [PART III](index=243&type=section&id=PART%20III) This section provides information on the company's directors, executive officers, corporate governance, executive compensation, security ownership, related transactions, and principal accountant fees [Item 10. Directors, Executive Officers and Corporate Governance](index=243&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance, including the Code of Business Conduct and Ethics, will be incorporated by reference from the 2024 Proxy Statement - Information on directors, executive officers, and corporate governance will be incorporated by reference from the **2024 Proxy Statement**[779](index=779&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics** applicable to all directors, officers, and employees, available on its investor relations website[780](index=780&type=chunk) [Code of Business Conduct and Ethics](index=243&type=section&id=Code%20of%20Business%20Conduct%20and%20Ethics) [Item 11. Executive Compensation](index=243&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation details will be incorporated by reference from the company's 2024 Proxy Statement - Information on executive compensation will be included in the **2024 Proxy Statement**, incorporated by reference[781](index=781&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=243&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information for beneficial owners and management, and related stockholder matters, will be incorporated by reference from the 2024 Proxy Statement - Information on security ownership of beneficial owners, management, and related stockholder matters will be incorporated by reference from the **2024 Proxy Statement**[782](index=782&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=243&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence will be incorporated by reference from the 2024 Proxy Statement - Information on certain relationships, related transactions, and director independence will be incorporated by reference from the **2024 Proxy Statement**[783](index=783&type=chunk) [Item 14. Principal Accountant Fees and Services](index=243&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services will be incorporated by reference from the 2024 Proxy Statement; BDO USA, P.C. is the independent auditor - Information on principal accountant fees and services will be incorporated by reference from the **2024 Proxy Statement**[784](index=784&type=chunk) - **BDO USA, P.C.** (**PCAOB Auditor ID 243**) is the independent registered public accounting firm[570](index=570&type=chunk)[784](index=784&type=chunk) [PART IV](index=244&type=section&id=PART%20IV) This section outlines the exhibits and financial statement schedules included in the report, and confirms the absence of a Form 10-K Summary [Item 15. Exhibits and Financial Statement Schedules](index=244&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists consolidated financial statements, confirms omission of schedules, and provides an index of exhibits incorporated by reference or filed - The section includes the **consolidated financial statements** as part of the report[787](index=787&type=chunk) - All financial statement schedules are **omitted** as they are not applicable or the required information is presented in the consolidated financial statements or notes[788](index=788&type=chunk) - An **Exhibit Index** lists documents incorporated by reference or filed with the report, numbered according to **Item 601 of Regulation S-K**[789](index=789&type=chunk)[792](index=792&type=chunk) [Item 16. Form 10-K Summary](index=244&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[790](index=790&type=chunk)

Acquisition and Strategic Focus - The company completed the acquisition of EryDel on October 20, 2023, issuing 6,525,315 shares, resulting in EryDel shareholders owning approximately 15.2% of the company[146]. - The company has shifted its strategic focus to rare diseases following the acquisition of EryDel, aiming to develop innovative therapeutics[143]. Financial Performance - The company incurred a net loss of $5.4 million and $22.5 million for the three and nine months ended September 30, 2023, respectively, with an accumulated deficit of $310.8 million[155]. - The net loss for the three months ended September 30, 2023, was $5.4 million, a reduction of 32.4% from a net loss of $7.9 million in the same period of 2022[173]. - The loss from operations for the nine months ended September 30, 2023, was $24.7 million, a decrease of 45.9% from a loss of $45.7 million in the same period of 2022[186]. - The company does not expect any additional expenses related to legacy assets COR388 and COR588 following their sale to Lighthouse in January 2023[189]. Cash and Investments - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $83.2 million, which is expected to fund operations into at least 2026[153]. - The company anticipates that existing cash will be sufficient to fund operations through at least 2026, assuming positive results from the Phase 3 NEAT trial[199]. - Net cash used in operating activities was $12.2 million for the nine months ended September 30, 2023, primarily due to a net loss of $22.5 million[208]. - Net cash used by investing activities was $11.1 million, primarily related to the purchase of investments of $95.1 million[210]. Research and Development - The company plans to initiate a pivotal Phase 3 NEAT trial for EryDex in the second quarter of 2024, targeting approximately 86 A-T patients aged six to nine years and 20 additional patients aged 10 years or older[143]. - Research and development expenses decreased to $1.4 million for the three months ended September 30, 2023, down from $2.4 million in the same period of 2022, representing a decrease of 41.6%[175]. - Total research and development expenses for the nine months ended September 30, 2023, were $6.0 million, a decrease of 73.2% from $22.4 million in the same period of 2022[186]. - The costs for atuzaginstat (COR388) development decreased by $1.2 million for the nine months ended September 30, 2023, primarily due to reduced drug manufacturing and consulting costs[187]. - For the nine months ended September 30, 2023, costs for NOV004 increased by $0.9 million due to drug manufacturing costs in preparation for Phase 1 clinical trials, but will be minimal for the remainder of 2023[190]. - Other direct research costs decreased by $1.5 million primarily due to the winddown of pipeline development of legacy assets sold to Lighthouse in January 2023[191]. Cost Management - A cost reduction program was implemented in January 2023, resulting in a 47% reduction in workforce, with associated expenses of approximately $0.4 million[151]. - Personnel-related expenses decreased by $9.5 million, including a $4.9 million decrease in stock-based compensation and a $3.0 million reduction in headcount year over year[192]. - General and administrative expenses decreased approximately $9.7 million to $12.8 million, primarily due to a decrease in personnel-related expenses and legal fees[193]. - General and administrative expenses increased by $0.3 million to $4.7 million for the three months ended September 30, 2023, compared to $4.3 million for the same period in 2022, an increase of 7.3%[182]. Impairment and Charges - The company recorded a non-cash impairment charge of $5.9 million for intangible assets during the nine months ended September 30, 2023[186]. - An impairment charge of $5.9 million was recorded for the IPR&D intangible asset due to a significant decrease in fair value[194]. Interest Income - Interest income increased significantly by 204.4% to $959,000 for the three months ended September 30, 2023, compared to $315,000 in the same period of 2022[173]. - Interest income increased to $2.5 million for the nine months ended September 30, 2023, compared to $0.5 million for the same period in 2022, due to increased yields on the investment portfolio[195].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) ( State o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware ...