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].

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].