QNCX

Primary and key secondary endpoint did not achieve statistical significance eDSP was generally well tolerated with no clinically meaningful safety concerns identified Company to cease clinical development of eDSP; Intends to preserve cash and explore available options SOUTH SAN FRANCISCO, Calif., January 29, 2026--(BUSINESS WIRE)--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 topline results from its pivotal Phase 3 NEAT clinical trial evaluating its lead asset, dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP), in patients with Ataxia-Telangiectasia (A-T). In the NEAT study, the company’s pivotal Phase 3 international, multicenter, randomized, double-blind, placebo-controlled study (n=105), the primary endpoint, which measured the change from baseline to last efficacy visit at month six using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo, did not reach statistical significance. The mean change from baseline to month six was 0.94 in the active arm compared to 2.24 in the placebo arm (difference -1.30) with a p-value of 0.0851. Furthermore, the study did not meet its key secondary endpoint of improvement in Clinical Global Impression of Severity (CGI-S) measured from baseline to month six with a p-value of 0.522. eDSP was generally well tolerated and there were no clinically meaningful safety concerns identified. The most common adverse events reported in the eDSP arm included pruritis and pyrexia. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We express our compassion and hope for future therapeutic options to the A-T community. We have tremendous gratitude toward the patients, their families, academic investigators and study sites, as well as all Quince employees, who worked so diligently over many years on this program." About Pivotal Phase 3 NEAT Clinical Trial NEAT (Neurological Effects of eDSP in Subjects with A-T; NCT06193200/IEDAT-04-2022) was an international, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP in patients with A-T. A total of 105 participants were randomized across leading academic centers, including four clinica...

Pivotal Phase 3 NEAT clinical trial evaluating lead asset, eDSP, for the treatment of A-T remains on track with topline results expected in first quarter of 2026 SOUTH SAN FRANCISCO, Calif., November 12, 2025--(BUSINESS WIRE)--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 provided an update on the company’s development pipeline and reported financial results for the third quarter ended September 30, 2025. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "Quince remains on track to report topline results for our pivotal Phase 3 NEAT clinical trial evaluating our lead asset eDSP (encapsulated dexamethasone sodium phosphate) for the treatment of Ataxia-Telangiectasia (A-T) in the first quarter of 2026. The NEAT study is powered at approximately 90% to test for a statistically significant difference between eDSP and placebo, and data management metrics suggest low rates of missing data and study discontinuations. Additionally, all patients completing the NEAT study have elected to participate in the open label extension (OLE) study. We also recently received a positive outcome of a NEAT safety analysis conducted by an independent data and safety monitoring board (iDSMB), which recommended that the study continue without any modifications. All of these factors support our ongoing confidence in a successful outcome for our pivotal Phase 3 NEAT clinical trial." Pivotal Phase 3 NEAT Clinical Trial Quince completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in July 2025 with a total of 105 participants, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older. Quince expects to report topline results from its Phase 3 NEAT clinical trial in the first quarter of 2026. Concluding the NEAT study with 83 enrolled participants in the six to nine year-old primary analysis population reflects powering of approximately 90% to determine statistical significance on the primary endpoint. 100% of NEAT participants to date have elected to transition to the OLE study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study...

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 into strategic relationship with Option Care Health to support commercial launch of eDSP in the U.S. SOUTH SAN FRANCISCO, Calif., August 11, 2025--(BUSINESS WIRE)--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 provided an update on the company’s development pipeline and reported financial results for the second quarter ended June 30, 2025. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We achieved many critical milestones over the last quarter that significantly advance our research programs and strengthen our business model. Specifically, we completed enrollment in our pivotal Phase 3 NEAT clinical trial, secured additional financing to extend our operating runway sufficiently beyond topline results, and solidified our commercial development planning through our strategic partnership with Option Care Health. Quince remains confident in our ability to deliver topline results in the first quarter of 2026 and subsequent NDA submission in the second half of 2026, assuming positive study results." Pivotal Phase 3 NEAT Clinical Trial Quince completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial with a total of 105 participants, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older. Quince expects to report topline results from its Phase 3 NEAT clinical trial in the first quarter of 2026. Concluding the NEAT study with 83 enrolled participants in the six to nine year-old primary analysis population reflects powering of approximately 90% to determine statistical significance of the primary endpoint. All 50 NEAT participants to date have elected to transition to the open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Participants who com...

Plan to potentially conclude enrollment early for Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T) to align topline results with existing cash runway SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--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 provided an update on the company’s development pipeline and reported financial results for the first quarter ended March 31, 2025. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "In light of current cash runway and with the goal of maximizing a capital efficient development plan, Quince has made the strategic business decision to potentially conclude enrollment of our pivotal Phase 3 NEAT clinical trial early by the end of June 2025 absent additional funding to extend our cash runway beyond the first quarter of 2026. Several factors contributed to this shift in strategy, including slower than anticipated enrollment, uncertain macroeconomic environment, challenging academic site environment, and an operationally well-executed study with limited withdrawals and low rates of missing data and procedural deviations. The combination of these factors leads us to now consider concluding enrollment prior to reaching the pre-specified target of 86 patients in the primary analysis population. "It is important to highlight that the potential to conclude enrollment at the end of June 2025 is expected to provide an approximate 80% power to determine a statistically significant difference in the primary endpoint. Additionally, this timeline would allow the company to report topline results by early 2026 while maintaining a positive cash balance. Assuming positive results from the NEAT trial, we plan to submit applications for approval in the U.S. and Europe in the second half of 2026," said Thye. Patient Enrollment in Pivotal Phase 3 NEAT Clinical Trial Quince is contemplating an early conclusion of enrollment for its pivotal Phase 3 NEAT clinical trial by the end of June 2025 to align the reporting of topline results with the company’s existing cash runway in early 2026. To date, a total of 63 participants have been enrolled, including 56 participants in the six to nine year-old primary analysis population and seven participants aged 10 years o...

Phase 3 NEAT clinical trial exceeds 50% enrollment with new study site activations expected to accelerate screenings and randomization Existing cash position of $40.8 million expected to provide operating runway through Phase 3 topline results into 2026 SOUTH SAN FRANCISCO, Calif., March 24, 2025--(BUSINESS WIRE)--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 provided an update on the company’s development pipeline and reported financial results for the fiscal year ended December 31, 2024. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "Our Phase 3 pivotal NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized. Recent and upcoming new site activations are expected to accelerate enrollment through our target completion date in the second quarter of 2025. Assuming target enrollment completion, topline results from the NEAT study are anticipated in the fourth quarter of 2025." Pivotal Phase 3 NEAT Clinical Trial Enrolled 61 participants to date in the company’s Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate the neurological effects of eDSP (previously referred to as EryDex) in patients with Ataxia-Telangiectasia (A-T), including 54 participants in the six to nine year-old primary analysis population. Transitioned 24 participants to date to the NEAT open label extension study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to an open label extension study. Expect screening and randomization to accelerate in the coming weeks due to several new geographic regions and sites scheduled for activation. Quince plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older. Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Autho...