SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)---- $QNCX #biotech--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced that it will host a virtual Investor Day on Thursday, October 2, 2025, from 10:00 a.m. and 12:00 p.m. Eastern Time. Quince's virtual Investor Day will feature presentations from the company's leadership team who will share the latest clinical development and ...

Quince Therapeutics (QNCX) FY Conference September 05, 2025 07:00 AM ET Speaker0Wainwright 27th Annual Global Investment Conference. My name is Maya, and I'm a Research Associate here at Wainwright. We're excited to introduce you to about 600 companies presenting at our conference this year across our key sectors of life sciences, cryptocurrency and fintech, clean tech, metals and mining, and TMT. I'd like to welcome Dirk Thye, MD, CEO, Chief Medical Officer, and board member of Quince Therapeutics. Quince ...

Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION (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, 2025 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 ...

Exhibit 99.1 Quince Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results Marks major milestone with completion of enrollment in pivotal Phase 3 NEAT clinical trial evaluating lead asset, eDSP, for the treatment of A-T; topline results expected in first quarter of 2026 Closed financing priced at a premium bringing existing cash position to approximately $35 million; expected to provide runway through Phase 3 topline results and into at least second quarter of 2026 Entered i ...

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

Quince Therapeutics ( QNCX ) is pursuing the treatment of ataxia-telangiectasia, a rare neurodegenerative disorder, which starts in early childhood. I have covered the company in the summer of 2024, and the stock has performedI am working in the financial sector. My areas of interest are technology, biotech, pharmaceutical companies, banks and a bit of shipping when an actionable trade passes on my radar.Analyst’s Disclosure: I/we have a beneficial long position in the shares of QNCX either through stock ow ...

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].