Latest news with #Ataxia-Telangiectasia
Business Wire
10-07-2025
- Business
- Business Wire
Quince Therapeutics Appoints Leading Immunologist Dr. Hassan Abolhassani to Scientific Advisory Board
SOUTH SAN FRANCISCO, Calif.--(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, announced the appointment of 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 Ataxia-Telangiectasia (A-T), biochemistry, neurology, immunology, genetic, hematology, pharmacology, and clinical practice. Dr. Mauro Magnani, Ph.D., Chair of Quince's Scientific Advisory Board, said, 'Quince is excited to welcome leading immunologist and researcher Dr. Abolhassani as a new member of our SAB. Given his notable work in immunodeficiency disorders, as well as the rare pediatric neurodegenerative disease Ataxia-Telangiectasia, we expect to benefit from his unique insight and expertise as the SAB continues to support Quince as the company advances its potentially breakthrough ability to deliver corticosteroid treatment without toxicities with its lead asset eDSP.' Dr. Hassan Abolhassani said, 'It is an honor to join Quince's SAB at this exciting time as the company prepares to report topline results in the first quarter of 2026 evaluating the company's lead asset, eDSP, for the treatment of patients with A-T. I look forward to collaborating with the distinguished members of Quince's management team, Board of Directors, and Scientific Advisory Board to support the advancement of eDSP for the treatment of not only A-T but for additional potential immunological and autoimmune focused rare disease indications.' Hassan Abolhassani, M.D., Ph.D., currently serves as Assistant Professor of Clinical Immunology and Research Specialists in the Department of Medical Biochemistry and Biophysics at the Karolinska Institutet in Stockholm, Sweden where he also is the team leader of pediatrics primary immunodeficiency (PID) and inborn errors of immunity (IEI) research in the lab of Professor Qiang Pan Hammarström, M.D., Ph.D. Dr. Abolhassani's translational clinical research aims to investigate the pathogenesis of primary antibody deficiency and the immune pathways involved that may help physicians and immunologists to understand genes with currently unknown functions and to aid in deciding therapeutic approaches for patients. Additionally, his work includes multidisciplinary and translational approaches for diagnosis and treatment of Ataxia-Telangiectasia. Dr. Abolhassani is recognized in the top 1% of highly cited scientific researchers in the field of immunology (Essential Science Indicators) and the world's top 2% widely cited scientists (Scopus/Elsevier). He has received several awards, including the Isil Berat Barlan Award in primary immunodeficiency diseases, the Anna-Greta Crafoords Prize for rheumatologic research, the USERN Prize in medical sciences, the Jonas Söderquist Award in virology and immunology, and the Razi Festival Award in medical sciences, among others. Dr. Abolhassani is the president of the Middle East and North Africa Registry on Inborn Errors of Immunity, one of the largest PID/IEI cohorts worldwide, is a steering member of the J Project, a professional network of experts on PID/IEI, and a distinguished clinical immunologist collaborator of the Global Burden of Disease study led by the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. Dr. Abolhassani received a M.D. from Tehran University of Medical Sciences where he also completed an internship for immune disorders at the Research Center for Immunodeficiencies. Additionally, he received a Ph.D. in clinical immunology and immunogenetics of chronic infectious and inflammatory disease from the Karolinska Institutet where he also completed his postdoctoral fellowship in single-cell multi-omics. Dr. Abolhassani holds a Master of Public Health and a Master of Philosophy from Tehran University of Medical Sciences and received a Doctor of Philosophy from the Karolinska Institutet. Quince's SAB provides expert insight and advice to support the advancement of its lead asset eDSP for the treatment of A-T for which a pivotal Phase 3 clinical trial is currently underway. The SAB also serves as a valuable resource as the company strategically expands its development pipeline by pursuing other potential rare disease indications beyond A-T and Duchenne muscular dystrophy (DMD) for eDSP where chronic corticosteroid treatment is – or has the potential to become – a standard of care, if there were not corticosteroid-related safety concerns. The prioritized list of other potential rare disease targets under consideration includes: 1) autoimmune hepatitis, 2) pulmonary sarcoidosis, 3) dermatomyositis, 4) pemphigus vulgaris, 5) Hashimoto's encephalopathy, 6) Becker muscular dystrophy, 7) pediatric lupus, 8) juvenile idiopathic arthritis, 9) myasthenia gravis, 10) limb-girdle muscular dystrophy, and 11) chronic inflammatory demyelinating polyradiculoneuropathy. 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 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; 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; 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.
Business Wire
18-06-2025
- Business
- Business Wire
Quince Therapeutics Announces Closing of Up to $22 Million Private Placement of Securities
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX) ('Quince' or the 'Company'), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced the closing of its previously announced sale and issuance to certain institutional and accredited investors, of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ('Warrants') that 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 for cash, before deducting placement agent fees and other private placement expenses. The private placement priced at a premium and was led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince's senior management. Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, 'We are pleased to secure additional financing that allows us to complete enrollment of our pivotal Phase 3 NEAT clinical trial and extend our cash runway beyond topline results. This transaction reflects a significant commitment from high caliber healthcare investors who believe in our technology platform and Phase 3 asset, eDSP. Success in our lead indication of Ataxia-Telangiectasia (A-T) would demonstrate our ability to deliver corticosteroid efficacy without toxicity and would expand opportunities for pursuing additional indications for both rare and non-rare diseases.' Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company's pivotal Phase 3 NEAT (N eurological E ffects of e DSP on Subjects with A - T; NCT06193200 / IEDAT-04-2022) clinical trial in A-T, research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince's current cash, cash equivalents, and short-term investments of $31.6 million as of March 31, 2025, are expected to fund the Company's operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. In addition, the Company expects to use proceeds to continue to expand and accelerate its development pipeline by funding new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP. The Company continues to make meaningful progress in enrolling participants in its pivotal Phase 3 NEAT clinical trial. Key highlights to date include: A total of 95 participants have been enrolled, including 77 participants in the six to nine year-old primary analysis population and 18 participants aged 10 years or older. All 39 NEAT participants to date have elected to transition to the NEAT 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. Quince expects to report topline results from the Phase 3 NEAT clinical trial in the first quarter of 2026. Assuming positive study results, the Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (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 for eDSP 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 in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. About the Private Placement At the closing, the Company issued to the investors an aggregate of 6,671,928 shares of common stock, 2,000,000 pre-funded warrants and accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company's common stock on June 11, 2025). The accompanying Warrants have an exercise price of $1.20 per share and are exercisable immediately. The Warrants will expire five years from the date of issuance. Citizens Capital Markets acted as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agents for the private placement. The securities issued in connection with the private placement described above were offered in a private placement and were not registered under the Securities Act of 1933, as amended (the 'Securities Act'), or any state or other applicable jurisdictions' securities laws, and were not offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements made in this news release that are not statements of historical or current facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the receipt of additional gross proceeds if the accompanying Warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the Company's intended use of the proceeds from the private placement, including the expected funding of new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP; the potential for expanded opportunities for pursuing additional indications for both rare and non-rare diseases if A-T is successful; the Company's expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026 if all Warrants are exercised for cash; and the Company's strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the Company's ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince's business operations and activities. There can be no assurance that the Company will be able to complete the proposed private placement on acceptable terms, or at all. Quince's actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of Quince's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of its Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.
Yahoo
12-06-2025
- Business
- Yahoo
Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities
Financing to provide $11.5 million in upfront proceeds with up to an additional $10.4 million of proceeds assuming exercise in full of the warrants Financing priced at a premium to last close SOUTH SAN FRANCISCO, Calif., June 12, 2025--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX) ("Quince" or the "Company"), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ("Warrants") that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses. The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince's senior management. Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company's pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince's current cash, cash equivalents, and short-term investments are expected to fund the Company's operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company's common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions. Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement. The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdictions' securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 Forward-looking Statements Statements made in this news release that are not statements of historical or current facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the expected closing of the private placement; the receipt of additional gross proceeds if the accompanying common warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the company's intended use of the proceeds from the private placement; the company's expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026, assuming all warrants are exercised for cash; and the company's strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the company's ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince's business operations and activities. There can be no assurance that the company will be able to complete the proposed private placement on acceptable terms, or at all. Quince's actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of Quince's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of its Quarterly Reports on Form 10-Q and in the company's other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law. View source version on Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
12-06-2025
- Business
- Business Wire
Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX) ('Quince' or the 'Company'), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ('Warrants') that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses. The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince's senior management. Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company's pivotal Phase 3 NEAT (N eurological E ffects of e DSP on Subjects with A - T; NCT06193200 / IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince's current cash, cash equivalents, and short-term investments are expected to fund the Company's operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company's common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions. Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement. The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the 'Securities Act'), or any state or other applicable jurisdictions' securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 Forward-looking Statements Statements made in this news release that are not statements of historical or current facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the expected closing of the private placement; the receipt of additional gross proceeds if the accompanying common warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the company's intended use of the proceeds from the private placement; the company's expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026, assuming all warrants are exercised for cash; and the company's strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the company's ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince's business operations and activities. There can be no assurance that the company will be able to complete the proposed private placement on acceptable terms, or at all. Quince's actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of Quince's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of its Quarterly Reports on Form 10-Q and in the company's other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.
Yahoo
03-06-2025
- Business
- Yahoo
Quince Therapeutics Exceeds 75% Enrollment in Pivotal Phase 3 NEAT Clinical Trial in Ataxia-Telangiectasia
SOUTH SAN FRANCISCO, Calif., June 03, 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 announced that its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has reached an important milestone as enrollment now exceeds 75% with a total of 65 participants randomized in the study's targeted 86 participants in the six to nine year-old primary analysis population. Key Phase 3 NEAT clinical trial enrollment highlights to date include: A total of 76 participants have been enrolled, including 65 participants in the six to nine year-old primary analysis population and 11 participants aged 10 years or older. Study powering based on currently enrolled participants is approximately 80%. The rate of screening and randomization activities has materially increased with the recent activation of all study sites. A total of 108 NEAT participants have been screened to date with a low screen failure rate of 10%. All 37 NEAT participants to date have elected to transition to the NEAT 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. Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 for eDSP 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 in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. 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 for A-T 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 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; 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, including NDAs, 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 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 Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@ Sign in to access your portfolio
