RankAlpha logo
Back to Rankings

QNCX

Quince TherapeuticsF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
6
Stored
Transcripts
0
Recent loaded
Latest report
2026-08-14
Investor release

Document history

Earnings documents stored for QNCX.

6 shown
Investor releaseQuarter not tagged2026-08-14

Quince Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Update

GlobeNewswire
Completed acquisition of Orphai Therapeutics, adding LAM-001, an inhaled formulation of rapamycin for the treatment of multiple serious, underserved pulmonary diseases, to pipeline LAM-001 Phase 2b data in PH-ILD anticipated in the first quarter of 2028; Phase 2 data in BOS anticipated in the first quarter of 2027 Closed private placement financing, receiving $115 million in upfront gross proceeds, with potential for up to an additional $83 million upon exercise of warrants (including warrants issued to former Orphai stockholders) Cash and cash equivalents of $116 million as of June 30, 2026, expected to fund operations through the end of 2028 SOUTH SAN FRANCISCO, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2026. “This was a transformational quarter for the company with a renewed focus on a differentiated, late-stage pulmonary pipeline anchored by LAM-001 as well as a strengthened balance sheet to support our development plans,” said Dr. Brigette Roberts, former CEO of Orphai Therapeutics and Chief Corporate Affairs Officer of Quince Therapeutics. “We are pleased to have initiated the Phase 2b trial of LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and look forward to releasing top line bronchiolitis obliterans syndrome post lung transplant (BOS) data in the first quarter of next year. Inhibition of the mTOR pathway via LAM-001 has the potential to offer PH-ILD and BOS patients a new treatment option that is designed to target and potentially reverse key elements of the underlying pathophysiology of these devastating diseases.” Second Quarter and Recent Business Highlights Completed Orphai acquisition and closed a concurrent $115 million private placement financing. On May 18, 2026, Quince completed a stock-for-stock merger to acquire Orphai, a clinical-stage biotechnology company, bringing Orphai’s lead program, LAM-001, an inhaled formulation of rapamycin (an mTOR inhibitor), into the pipeline. LAM-001 is being developed for the treatment of serious, underserved pulmonary diseases, including PH-ILD, BOS, and sarcoidosis-as…Read full document

Completed acquisition of Orphai Therapeutics, adding LAM-001, an inhaled formulation of rapamycin for the treatment of multiple serious, underserved pulmonary diseases, to pipeline LAM-001 Phase 2b data in PH-ILD anticipated in the first quarter of 2028; Phase 2 data in BOS anticipated in the first quarter of 2027 Closed private placement financing, receiving $115 million in upfront gross proceeds, with potential for up to an additional $83 million upon exercise of warrants (including warrants issued to former Orphai stockholders) Cash and cash equivalents of $116 million as of June 30, 2026, expected to fund operations through the end of 2028 SOUTH SAN FRANCISCO, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2026. “This was a transformational quarter for the company with a renewed focus on a differentiated, late-stage pulmonary pipeline anchored by LAM-001 as well as a strengthened balance sheet to support our development plans,” said Dr. Brigette Roberts, former CEO of Orphai Therapeutics and Chief Corporate Affairs Officer of Quince Therapeutics. “We are pleased to have initiated the Phase 2b trial of LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and look forward to releasing top line bronchiolitis obliterans syndrome post lung transplant (BOS) data in the first quarter of next year. Inhibition of the mTOR pathway via LAM-001 has the potential to offer PH-ILD and BOS patients a new treatment option that is designed to target and potentially reverse key elements of the underlying pathophysiology of these devastating diseases.” Second Quarter and Recent Business Highlights Completed Orphai acquisition and closed a concurrent $115 million private placement financing. On May 18, 2026, Quince completed a stock-for-stock merger to acquire Orphai, a clinical-stage biotechnology company, bringing Orphai’s lead program, LAM-001, an inhaled formulation of rapamycin (an mTOR inhibitor), into the pipeline. LAM-001 is being developed for the treatment of serious, underserved pulmonary diseases, including PH-ILD, BOS, and sarcoidosis-associated pulmonary hypertension (SAPH).Concurrent with the acquisition, Quince entered into a definitive agreement for a private placement financing with gross upfront proceeds of $115 million, yielding net proceeds of $103.6 million after deducting placement agent and other offering expenses of $11.4 million, for the purchase of shares of Series C non-voting convertible preferred stock and up to an additional $83 million upon the exercise of warrants (including warrants issued to former Orphai stockholders). Advancing the LAM-001 clinical program. Clinical sites have been activated, and the company is actively screening subjects for its Phase 2b trial of LAM-001 in PH-ILD. Topline data is anticipated in the first quarter of 2028. The company also continues to expect data from the Phase 2 trial of LAM-001 in BOS in the first quarter of 2027. The Phase 2 trial of LAM-001 in SAPH is anticipated to begin in late 2026, with data expected in the fourth quarter of 2028. Presented new LAM-001 Phase 2a data at the American Thoracic Society (ATS) Conference. Data from the Phase 2a trial of LAM-001 in 10 adult patients with PAH and PH-ILD demonstrated clinically meaningful improvement across functional, hemodynamic, and biomarker measures of disease. A mean improvement in six-minute walk distance (6MWD) of 67.4 meters and a mean reduction in pulmonary vascular resistance (PVR) (supine) of 33.9% at 24 weeks were seen in PH-ILD patients. A mean 6MWD improvement of 81.3 meters and a mean reduction in PVR (supine) of 28.1% were seen in the combined evaluable population of PAH and PH-ILD patients. The drug was generally well tolerated in both populations. Formed Scientific Advisory Board (SAB). Appointed five internationally recognized experts in pulmonary medicine to an SAB – Dr. Paul Yu, Dr. Aaron Waxman, Dr. Steven Nathan, Dr. Steve Hays, and Dr. Robert Baughman – who Quince believes will be instrumental in helping to progress the development of LAM-001 across multiple pulmonary indications. Second Quarter 2026 Financial Results Cash position: Cash and cash equivalents were $116 million as of June 30, 2026, which reflects the $103.6 million in net upfront proceeds from the private placement. The Company expects that its cash position will be sufficient to fund operations through the end of 2028. Research and development (R&D) expense: R&D expense for the three months ended June 30, 2026 was $5.5 million, compared to $6.6 million for the three months ended June 30, 2025. The decrease in R&D expense is primarily due to the decrease in the eDSP program costs due to the wind down of the program. LAM-001 costs increased $0.8 million as a result of study start-up costs. General and administrative (G&A) expense: G&A expense for the three months ended June 30, 2026 was $16.6 million, compared to $3.3 million for the three months ended June 30, 2025. The increase in G&A expense is due to $9.1 million in non-cash stock-based compensation due to a one-time charge due to the assumption of historical options upon the closing of the acquisition and an increase of $4.4 million in professional fees due to the Quince restructuring prior to the completion of the acquisition. Net loss: Quince reported a net loss of $75.5 million, or net loss per share of $12.31 per basic and diluted share, for the three months ended June 30, 2026, compared to a net loss of $16.0 million, or net loss per share of $68.75 per basic and diluted share for the three months ended June 30, 2025. Shares outstanding: 978,022 shares of common stock were outstanding as of June 30, 2026. On April 10, 2026, Quince effected a reverse stock split of all shares of its issued and outstanding common stock at a ratio of 1-for-10. On June 29, 2026, Quince effected a reverse stock split of all shares of its issued and outstanding common stock at a ratio of 1-for-20. All issued and outstanding shares of common stock and share-based awards’ exercise prices and per share data herein have been adjusted, on a retrospective basis, to reflect the reverse stock splits. The number of authorized shares and par value of the common stock were not adjusted because of the reverse stock splits. About LAM-001 LAM-001 is a proprietary, investigational, once-daily inhaled formulation of rapamycin, also known as sirolimus. LAM-001’s potential as a disease-modifying agent in PH stems from its ability to inhibit mTOR-mediated pulmonary arterial smooth muscle cell proliferation, to limit endothelial cell dysfunction, and to suppress inflammatory signaling, leading to improvement in pulmonary vascular remodeling. The mTOR pathway has been shown to be activated in pulmonary arteries of patients with PH, and mTOR inhibition with rapamycin has been shown to reverse smooth muscle cell hyperproliferation and to attenuate pulmonary vascular remodeling and cardiopulmonary dysfunction in multiple published nonclinical models. Additionally, in published non-clinical studies, hyperactive mTOR signaling has been shown to promote fibroblast activation, myofibroblast differentiation, and extracellular matrix deposition in injured or inflamed lung tissue, and mTOR inhibition has been shown to exert direct antifibrotic activity, suppressing profibrotic cytokine signaling, reducing collagen accumulation, and attenuating parenchymal fibrosis. These effects are particularly relevant in PH-ILD, where vascular remodeling and progressive fibrosis evolve in parallel and amplify pulmonary vascular load. LAM-001 is designed to enhance pulmonary delivery and to reduce systemic exposure of rapamycin, offering a promising, potentially disease-modifying, therapy for multiple pulmonary diseases. LAM-001 is currently being studied in multiple indications including PH-ILD, a serious and progressive condition affecting an estimated 200,000 patients between the U.S. and Europe. Based on compelling Phase 2a data presented at the American Thoracic Society (ATS) in May 2026, the company has advanced LAM-001 into a Phase 2b PH-ILD trial and data is anticipated in the first quarter of 2028. LAM-001 is also being evaluated in a Phase 2 study in bronchiolitis obliterans syndrome post lung transplant (BOS), a serious complication with an estimated prevalence of ~30K patients between the U.S. and Europe by 2032. The trial is fully enrolled, and data is anticipated in the first quarter of 2027. In late 2026, the company also plans to initiate a Phase 2 study of LAM-001 in sarcoidosis-associated pulmonary hypertension (SAPH), a severe complication of pulmonary sarcoidosis with no approved therapy, that affects an estimated ~60K patients in the U.S. and Europe. About Quince Therapeutics, Inc. Quince Therapeutics, Inc. is committed to transforming the lives of patients facing serious, underserved diseases by developing disease-modifying therapies to treat their conditions. The company is currently developing LAM-001 for the treatment of PH-ILD, BOS, and SAPH. A Phase 2a study in PH patients has been completed, a Phase 2 clinical study in BOS patients is ongoing, a Phase 2b study in PH-ILD is ongoing, and a Phase 2 study in SAPH is anticipated to begin in late 2026. By pioneering innovative approaches, the company aims to offer new hope and improved quality of life to patients worldwide. Forward-Looking Statements Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the design and potential benefits of LAM-001, including as a disease-modifying therapy for pulmonary disease; anticipated regulatory and development processes and timelines, including the expected timing to initiate the planned Phase 2 trial of LAM-001 in SAPH, the expected timing for data readouts from the ongoing Phase 2 trial of LAM-001 in BOS and the ongoing Phase 2b trial of LAM-001 in PH-ILD; the Phase 2a data of LAM-001 in PAH and PH-ILD supporting continued development of LAM-001 in PH-ILD and the potential benefit across exercise capacity, pulmonary hemodynamics, cardiac stress and lung function; observed improvements in 6MWD and PVR in the Phase 2a trial potentially suggesting broader effects on cardiopulmonary physiology; the estimated patient populations in the U.S. and Europe for PH-ILD, BOS and SAPH; the potential advantages of mTOR inhibitors in PH-ILD, BOS and SAPH; and the company’s anticipated cash runway. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to LAM-001; the ability to obtain and maintain regulatory approval; competition in the company’s industry; the scope, progress and expansion of developing LAM-001; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the company’s ability to attract or retain key management, members of the board of directors and other personnel; the company’s ability to fund its operations and clinical development plans, including its anticipated cash runway; the impacts of general macroeconomic and geopolitical conditions on the company’s business and financial position; and other risks and uncertainties described in the section titled “Risk Factors” in the company’s Amendment No. 2 to its Current Report on Form 8-K filed with the Securities and Exchange Commission (SEC) on July 30, 2026 and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. Contacts Corey Davis, Ph.D.LifeSci Advisors, [email protected]

Investor releaseQuarter not tagged2026-01-30

Quince Therapeutics Announces Topline Results from Pivotal Phase 3 NEAT Clinical Trial of eDSP in Ataxia-Telangiectasia

Business Wire
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…Read full document

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 clinical sites in the U.S. and 18 in the U.K. and Europe. The study consisted of two cohorts randomized (1:1) between eDSP or placebo and the treatment included six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint was measured by the change from baseline to last efficacy visit at month six using RmICARS compared to placebo. RmICARS is a refined version of the International Cooperative Ataxia Rating Scale (ICARS), a standard, clinician-administered tool used to quantify ataxia severity, which places increased focus on posture and gait disturbance with higher sensitivity in children ages six to 10 years old. Quince enrolled a total of 105 participants in the NEAT study, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older. Participants who completed the full treatment period, completed study assessments, and provided informed consent were eligible to transition to the company’s open label extension (OLE) study (NCT06664853/IEDAT-05-2024). All but one of the participants elected to transition to the 24-month OLE. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the Company’s intentions to preserve cash and explore available options. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on November 12, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260129349326/en/ Contacts Media & Investor Contact: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations [email protected]

Investor releaseQuarter not tagged2025-11-13

Quince Therapeutics Provides Business Update and Reports Third Quarter 2025 Financial Results

Business Wire
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…Read full document

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 assessments, and provide informed consent are eligible to transition to the OLE study. The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026. Quince was granted FDA Fast Track designation for the company’s eDSP System for the treatment of patients with A-T based on the potential to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex), in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. Pipeline and Corporate Updates Hosted a virtual 2025 Investor Day on October 2, 2025 showcasing Quince’s latest clinical development and corporate updates, the replay of which can be accessed here. Notable featured topics included a presentation of multiple synergistic mechanisms of action that support eDSP’s potential efficacy and disease modifying activity while mitigating corticosteroid toxicity, and how transcriptomic profiling reveals novel insights and potential biomarkers in A-T; insights into the company’s attractive commercial opportunity and launch preparedness planning for eDSP, including details of its recently announced strategic relationship with Option Care Health; a look at Quince’s strong competitive positioning and significant opportunity to quickly expand its development pipeline into additional high-value, rare disease indications; as well as a demonstration of the company’s proprietary drug/device combination eDSP System, among other key topics and highlights. Announced the outcome of the company’s pre-planned safety analysis conducted by an independent data and safety monitoring board (iDSMB) for its Phase 3 NEAT clinical trial with the iDSMB recommending that the study continue without any modifications. Pursuing ongoing study initiation activities to support Quince’s European Union pediatric investigational plan (PIP) – named the Pediatric Encapsulated Dexamethasone Sodium Phosphate (PeD) study – to evaluate the safety and pharmacokinetics of eDSP in smaller patients with A-T who weigh between nine and 15 kilograms. Advanced commercial readiness activities, including completion of qualitative payer research covering more than 200 million U.S. lives. Findings were highly encouraging with payers recognizing the significant unmet need in A-T and expressing broad support for eDSP as a potential first-to-market treatment. Participated at the 54th Child Neurology Society (CNS) Annual Meeting with a poster presentation of patient-reported walking capacity in children with A-T, which describes the pattern of age-related walking capacity loss in patients with A-T and compares the subjective walking scale to the two measures – International Cooperative Ataxia Rating Scale (ICARS) and Rescored modified ICARS (RmICARS) – used in Quince’s Phase 3 NEAT clinical trial. Results showed that all three scales tracked age-related loss of ambulation in a similar way, suggesting suitability of RmICARS walking capacity components in assessing A-T disease progression. Continuing advancement of the evaluation of Duchenne muscular dystrophy (DMD) as Quince’s second targeted eDSP indication, including preparing for protocol finalization, contract research organization (CRO) evaluation and selection, and site feasibility in preparation for dosing the first patient in a DMD Phase 2 clinical study in 2026. Published an advanced population pharmacokinetic (PK) modeling study in the scientific journal CPT: Pharmacometrics & Systems Pharmacology (PSP) that addresses the development of a pediatric PK model based on data from the study of healthy adults and pediatric patients with A-T administered monthly with eDSP and predicts the exposure data in the A-T patient population over a six-month period, which is accessible here. Entered into a second amendment of Quince’s European Investment Bank (EIB) debt agreement in September 2025 that reduces the company’s required minimum cash balance for the period from January 1, 2026 to March 31, 2026 to €5.0 million. Received an update on the company’s previously sold legacy small molecule protease inhibitor portfolio acquired by Lighthouse Pharmaceuticals in January 2023. Lighthouse Pharma was awarded $49.2 million grant from the National Institute on Aging to support its Phase 2 clinical trial in patients with Alzheimer’s disease. Quince retains a 7.5% ownership position in Lighthouse Pharma and is positioned to benefit from milestone and royalty commitments related to Lighthouse’s ability to successfully advance the development of its compounds through regulatory approval and subsequent commercialization. Third Quarter 2025 Financial Results Reported cash, cash equivalents, and short-term investments of $26.3 million for the third quarter ended September 30, 2025. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. If warrants related to the company’s recent financing are exercised in full for cash, Quince’s cash runway would extend into the second half of 2026. Reported research and development (R&D) expenses of $8.1 million for the third quarter ended September 30, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $3.3 million for the third quarter ended September 30, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $13.3 million, or a net loss of $0.25 per basic and diluted share, for the third quarter ended September 30, 2025. Weighted average shares outstanding – basic and diluted – for the quarter were 54.0 million. Reported net cash used in operating activities of $30.9 million for the nine months ended September 30, 2025. Cash used in operating activities was primarily due to net loss of $44.5 million for the period, adjusted for $13.2 million of non-cash items, including $4.5 million change in the fair value of contingent consideration liabilities, $4.2 million change in the fair value of warrants, $3.9 million in stock-based compensation, $1.3 million change in the fair value of the EIB loan, and a net decrease in operating assets of $0.3 million, offset by a net increase in accounts payable, accrued expenses, and other current liabilities of $0.7 million. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing and outcome of Phase 3 NEAT topline results and submission of a related NDA; expected cash position and operating runway, including cash potentially receivable upon the exercise of warrants; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP, including the anticipated benefits of the strategic partnership with Option Care Health; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; potential benefits of eDSP and the company’s market opportunity; and potential benefits from the company’s investment in Lighthouse Pharmaceuticals. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on August 11, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251112266523/en/ Contacts Media & Investor Contact: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations [email protected]

Investor releaseQuarter not tagged2025-08-12

Quince Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results

Business Wire
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…Read full document

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 complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026. Quince was granted FDA Fast Track designation for the company’s eDSP System for the treatment of patients with A-T based on the potential to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. Pipeline and Corporate Updates Announced a strategic relationship with Option Care Health, Inc. (Nasdaq: OPCH), the nation’s largest independent provider of home and ambulatory infusion services, to support the commercial development and efficient launch of Quince’s lead asset, eDSP, in the U.S. The strategic relationship will leverage Option Care’s robust network of specialty pharmacy and ambulatory infusion suites to provide for the administration of eDSP in an effective and efficient way while delivering this innovative treatment to patients with greater geographic flexibility. Closed a private placement of common stock and accompanying warrants in June 2025 led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, Legend Capital Partners, and Lagfin S.C.A., new stockholder Second Line Capital, along with members of Quince’s senior management. Priced at a more than a 10% premium to the market price of Quince’s common stock, the financing resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million, if the accompanying warrants are exercised in full, before deducting placement agent fees and other private placement expenses. Finalized Phase 2 clinical trial study designs to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD), the company’s second targeted indication for its lead asset, eDSP. Quince plans to prioritize capital efficient study approaches, including potential investigator-initiated trials (IITs), to advance the evaluation of DMD as a second targeted eDSP indication. Initiated Study #3 in the company’s European Union pediatric investigational plan (PIP) – named the Pediatric Encapsulated Dexamethasone Sodium Phosphate (PeD) study – to evaluate the safety and pharmacokinetics of eDSP in younger patients with A-T who weigh between nine and 15 kilograms. Participated at the 2025 A-T Clinical Research Conference organized by the A-T Society, a leading A-T patient advocacy group based in the United Kingdom, where key opinion leaders (KOLs) presented post hoc data analyses from the company’s prior Phase 3 ATTeST clinical trial, in addition to Quince management providing an overview of the Phase 3 NEAT clinical trial. Appointed Dr. Hassan Abolhassani, Assistant Professor of Clinical Immunology and Research Specialists in the Department of Medical Biochemistry and Biophysics at the Karolinska Institutet in Stockholm, Sweden, to the company’s Scientific Advisory Board (SAB). Dr. Abolhassani becomes the ninth member to join Quince’s SAB, which is comprised of leading experts in A-T, biochemistry, neurology, immunology, genetic, hematology, pharmacology, and clinical practice. Second Quarter 2025 Financial Results Reported cash, cash equivalents, and short-term investments of $34.7 million for the second quarter ended June 30, 2025. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. If warrants related to the company’s recent financing are exercised in full for cash, Quince’s cash runway would extend into the second half of 2026. Reported research and development (R&D) expenses of $6.6 million for the second quarter ended June 30, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $3.3 million for the second quarter ended June 30, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $16.1 million, or a net loss of $0.34 per basic and diluted share, for the second quarter ended June 30, 2025. Weighted average shares outstanding for the year were 46.7 million. Reported net cash used in operating activities of $21.0 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to net loss of $31.1 million for the period, adjusted for $9.9 million of non-cash items, including $4.5 million change in the fair value of warrants, $2.7 million in stock-based compensation, $2.5 million change in the fair value of contingent consideration liabilities, $0.8 million change in the fair value of the European Investment Bank loan, and a net decrease in operating assets of $0.5 million, offset by a net increase in accounts payable, and accrued expenses, and other current liabilities of $0.3 million. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing of Phase 3 NEAT topline results and submission of a related NDA; expected cash position and operating runway, including cash potentially receivable upon the exercise of warrants; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP, including the anticipated benefits of the strategic partnership with Option Care Health; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250811018550/en/ Contacts Media & Investor Contact: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations [email protected]

Investor releaseQuarter not tagged2025-05-13

Quince Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results

Business Wire
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…Read full document

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 or older. All 19 study sites are now activated, including several additional sites opened in the U.K. and Europe. Slower than anticipated enrollment in recent months is primarily due to a challenging academic site environment. Quince expects an increased rate of screening and randomization activities in the near term due to the activation of new sites. Approximately seven participants are scheduled for screening over the coming week. A total of 80 NEAT participants have been screened to date and the study has a low screen failure rate of 10%. Quince’s potential early enrollment conclusion by the end of June 2025 would result in approximately 80% power to determine a statistically significant difference in the primary endpoint. If additional funding is secured in the near term, Quince intends to continue enrollment as previously planned targeting 86 patients with A-T ages six to nine years old in the primary analysis population. All 30 NEAT participants to date have elected to transition 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 the OLE study. New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) planned in the second half of 2026, assuming positive study results. NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. First Quarter 2025 Financial Results Reported cash, cash equivalents, and short-term investments of $31.6 million for the first quarter ended March 31, 2025. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results, which are now expected by early 2026. Reported research and development (R&D) expenses of $8.1 million for the first quarter ended March 31, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $4.8 million for the first quarter ended March 31, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $15.0 million, or a net loss of $0.34 per basic and diluted share, for the first quarter ended March 31, 2025. Weighted average shares outstanding for the year were 43.9 million. Reported net cash used in operating activities of $9.6 million for the first quarter ended March 31, 2025. Cash used in operating activities was primarily due to net loss of $15.0 million for the period, adjusted for $3.4 million of non-cash items, including $1.9 million change in the fair value of contingent consideration liabilities, $1.4 million in stock-based compensation, $0.4 million change in the fair value of the European Investment Bank loan and a net decrease in operating assets of $1.1 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $0.9 million. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250513193779/en/ Contacts Media & Investor Contact: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations [email protected]

Investor releaseQuarter not tagged2025-03-25

Quince Therapeutics Provides Business Update and Reports Fiscal Year 2024 Financial Results

Business Wire
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…Read full document

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 Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T. Participants will be randomized (1:1) between eDSP or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the SPA agreement with the FDA. Pipeline and Corporate Updates Generating Phase 2 clinical trial study designed to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD). Quince plans to initiate a DMD Phase 2 study in 2025, which the company expects to conduct utilizing capital efficient study approaches and with financial support from grant and/or opportunistic funding opportunities. Published long-term safety data from patients with A-T treated with eDSP for a minimum of 24 months in Frontiers in Neurology in January 2025. The online publication titled Long-term safety of dexamethasone sodium phosphate encapsulated in autologous erythrocytes in pediatric patients with Ataxia-Telangiectasia can be accessed here. Appointed Dr. William Whitehouse, Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham and recently retired Consultant Pediatric Neurologist at Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust, to the company’s Scientific Advisory Board (SAB). Strengthened Quince’s growing intellectual property portfolio and long-term market position with the issuance of a Notice of Allowance from the U.S. Patent and Trademark Office’s (USPTO) in February 2025. This extends the company’s patent claims into 2036 in the U.S., supplementing its existing U.S. patent with coverage of patent claims related to method of treating patients with A-T using Quince’s proprietary process to encapsulate DSP in autologous red blood cells. Held an investor webinar in February 2025 featuring key opinion leader (KOL) Dr. Mary Kay Koenig from UTHealth Houston with a discussion focused on addressing the high unmet need in A-T. During the investor webinar, Dr. Koenig 1) provided an A-T natural history overview, 2) detailed current symptomatic treatment approaches for patients with A-T, 3) discussed the competitive therapeutic A-T landscape, and 4) provided an overview of Quince’s Phase 3 NEAT clinical trial of eDSP for the treatment of A-T. A replay of the A-T KOL investor webinar is available here. Fiscal Year 2024 Operating Highlights Granted Fast Track designation from the FDA for Quince’s eDSP System for the treatment of patients with A-T in June 2024. Published efficacy and safety results from the company’s Phase 3 ATTeST clinical trial evaluating eDSP for the treatment of A-T in medical journal The Lancet Neurology. Participated at notable scientific meetings, including poster presentations at the 53rd Child Neurology Society (CNS) Annual Meeting and the 2024 International Congress for Ataxia Research (ICAR), where Quince presented data from its Phase 3 ATTeST clinical trial. Completed an initial patient sizing project based on third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that the number of diagnosed patients with A-T in the U.S. is estimated to be to approximately 4,600. Established a SAB comprised of leading experts in biochemistry, neurology, immunology, hematology, pharmacology, and clinical practice uniquely positioned to provide Quince with deep insights and advice to support advancement of the company’s drug programs. Fiscal Year 2024 Financial Results Reported cash, cash equivalents, and short-term investments of $40.8 million for the fiscal year ended December 31, 2024. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results and into 2026. The company plans to be opportunistic from a financing perspective to extend its existing cash runway. Reported research and development (R&D) expenses of $18.6 million for the fiscal year ended December 31, 2024. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $17.6 million for the fiscal year ended December 31, 2024. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $56.8 million, or a net loss of $1.31 per basic and diluted share, for the fiscal year ended December 31, 2024. Weighted average shares outstanding for the year were 43.3 million. Reported net cash used in operating activities of $31.9 million for the year ended December 31, 2024. Cash used in operating activities was primarily due to a net loss of $56.8 million for the period, adjusted for $25.4 million of non-cash items, including a $17.1 million goodwill impairment charge, $4.7 million in stock-based compensation, $4.0 million change in the fair value of contingent consideration liabilities, $1.7 million change in the fair value of long-term debt, and a net increase in operating assets of $2.6 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $ 2.1 million. Made a cash milestone payment of $5.0 million to EryDel shareholders in the third quarter of 2024 following the achievement of the first patient enrolled in the NEAT study in the second quarter of 2024. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support, including from grant or opportunistic funding opportunities; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250324815304/en/ Contacts Media & Investor Contact: Stacy Roughan Quince Therapeutics, Inc. Vice President, Corporate Communications & Investor Relations [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook