D. Boral Capital analyst Jason Kolbert raised the firm’s price target on Quince Therapeutics (QNCX) to $5 from $4 and keeps a Buy rating on the shares after the company said the last patient has completed their last visit in the pivotal Phase 3 NEAT clinical trial evaluating encapsulated dexamethasone sodium phosphate in patients with Ataxia-Telangiectasia. The firm cites the rolling of its valuation metrics out a year for the target bump. Claim 50% Off TipRanks Premium and Invest with Confidence Unloc ...

Quince Therapeutics FY Conference Summary Company Overview - **Company**: Quince Therapeutics (NasdaqGS:QNCX) - **Industry**: Biotechnology, specifically focused on therapies for rare genetic diseases Key Points and Arguments 1. **Pivotal Studies**: Quince Therapeutics is preparing for pivotal studies to read out in February 2026, which are crucial for the company's future [1][2][3] 2. **Acquisition of EryDel**: The company acquired EryDel, which had developed a drug-device combination technology over 20 years with approximately $100 million in venture investment [4][5] 3. **Therapeutic Technology**: The technology involves a tabletop machine that processes a small volume of the patient's blood to encapsulate drugs, allowing for chronic administration without toxicity [5][6] 4. **Lead Compound**: The lead compound is dexamethasone, which is encapsulated in red blood cells to mitigate the toxicity associated with chronic steroid use [6][7] 5. **Target Population**: The current study focuses on children aged six to nine with ataxia telangiectasia, a severe genetic disease, based on previous trial results that showed significant benefits in this age group [7][12] 6. **Previous Trial Insights**: The ATTEST study provided insights that led to the design of the NEAT study, including the importance of selecting a younger patient population for better outcomes [15][18] 7. **FDA Engagement**: The company has engaged with the FDA regarding the primary outcome measures and has reached an agreement under a Special Protocol Assessment for the NEAT study [18][19] 8. **Safety Monitoring**: The Data Safety Monitoring Board (DSMB) has reviewed both blinded and unblinded data, concluding that there are no safety signals, allowing the study to continue [19][20][21] 9. **Efficacy Expectations**: The company anticipates that a statistically significant change of 1.5 points on the RMICARS scale would be clinically meaningful for patients [27][29] 10. **Market Opportunity**: There are approximately 5,000 patients in the U.S. with ataxia telangiectasia, with potential for underdiagnosis due to the lack of approved treatments [49][53] 11. **Cost Structure**: The machine used for the therapy costs about $25,000 to produce, and the cost of goods for the therapy is expected to be very low, around 2% or less [56][58] 12. **Pricing Strategy**: The anticipated pricing for the therapy is in the range of $500,000 to $700,000 per year, reflecting the high unmet need in this rare disease space [63] Additional Important Information - **Regulatory Pathway**: The company is following a 505(b)(2) pathway for the NDA submission, which simplifies some aspects of the nonclinical development plan [45][46] - **Commercial Strategy**: Quince Therapeutics has signed a contract with an outpatient infusion network to ensure access to treatment for patients across major population centers [95] - **Patient Management**: Patients are typically managed by local physicians after diagnosis, with the company planning to link its commercial strategy to population centers [91][95] - **Genetic Insights**: The company is working with academic partners to better understand the epidemiology of ataxia telangiectasia through genetic databases [51][52] This summary encapsulates the critical aspects of Quince Therapeutics' current position, upcoming studies, and market strategy, providing a comprehensive overview for potential investors and stakeholders.

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

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

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

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

eDSP and A-T Treatment - Quince Therapeutics is developing eDSP, a red blood cell encapsulated dexamethasone sodium phosphate, for treating rare diseases, with a focus on Ataxia-Telangiectasia (A-T)[12] - The Phase 3 NEAT clinical trial for A-T has completed enrollment with 105 participants, including 83 in the primary analysis population aged 6-9 years, and topline data is expected in the first quarter of 2026[14, 74, 76] - A-T affects an estimated 10,000 patients in the U S, UK, and EU4 countries, and there are currently no approved treatments[50, 124] - The company estimates a $1+ billion global peak commercial opportunity for eDSP in the A-T indication[14, 33, 34, 124, 125] - The company has $34.7 million in cash, providing funding through topline results in Q1 2026 and potentially into the second half of 2026 if warrants are exercised[14] eDSP Technology and Mechanism - Over 20 years of R&D and $100 million have been invested in the Autologous Intracellular Drug Encapsulation (AIDE) technology used in eDSP[17, 36] - eDSP is designed to deliver corticosteroids in a patient's own red blood cells, aiming to provide efficacy without the toxicity associated with traditional corticosteroid use[17, 18] - RNA sequencing analysis of ATTeST trial samples revealed that eDSP demonstrates a classic glucocorticoid gene signature, including suppression of interferon-stimulated genes and downregulation of inflammation[105, 107, 108] Commercial and Regulatory Strategy - Quince has entered a strategic partnership with Option Care Health, the largest independent provider of home and outpatient infusion services in the U S, for eDSP administration[14] - The eDSP system has secured CE mark in Europe for clinical trial use, and the company has an active Investigational New Drug (IND) application for over 10 years[45] - The Phase 3 NEAT trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, and the company plans to submit a New Drug Application (NDA) in the second half of 2026, seeking Priority Review[73, 121] Pipeline Expansion - Duchenne muscular dystrophy (DMD) has been selected as the second targeted indication for eDSP, with plans to initiate a Phase 2 clinical study in 2026[14, 33, 163]

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

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

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