Phase 3 clean clinical trial is exceeding 50 % entry with new study site activities, which is expected to be screening and random
.8 40.8 million current cash position is expected to provide operating runway through Phase 3 Topline results in 2026
South San Francisco, California, March 24, 2025-((Business wire)-Quins therapatics, Inc. (Nes Deck: QNCX), which is dedicated to opening the patient’s own biology strength for the treatment of rare diseases, today provided a refreshing result on the company’s development pipeline on December 31, on December 31.
“Our step 3 has exceeded 50 percent entry with 71 participants and 61 random entries,” said Dirk T. MD, MD, MD, MD, Chief Executive Officer and Chief Medical Officer of Queens. Recent and upcoming new site activities are expected in the second quarter of 2025.
Important Step 3 Clean Clinical Trial
Phase 3 of the company (registered 61 participants to date (nUrological EFFECTS EDSP on subjects with A– from.t; NCT06193200).).IEDAT-04-2022) Ataxia-telangiectasia (AT) patients to evaluate the neurological effects of EDSP (known as Eredex), including 54 participants in the population of six to nine-year-old primary analysis.
Clean Open Label Extension Studies transferred to 24 participants till date (NCT06664853).).IEDAT-04-2022) Participants who complete the full period of treatment, completely diagnose the study, and provide informed consent, are eligible for the transfer of open label extension studies.
Expect to be screening and random in the coming weeks due to several new geographical areas and scheduled sites for activation.
Queens plans to register about 86 86 patients and about 20 20 patients with 20 patients aged six to nine years (the basic analysis population) and 20 years or older.
A significant phase 3 clean clinical trial is being conducted under a special protocol diagnosis agreement with the US Food and Drug Administration (FDA).
With a new drug application (NDA) in 2025, a new drug application (NDA) will submit a new drug application (NDA) with a new drug application (NDA), with a new drug application (NDA), with a new drug application (EMA) in 2026 for the European Medicine Agency (EMA) in 2026.
Clear is an international, multi -center, random, double blind, Placebo -controlled study to assess the company’s lead asset, EDSP (Dexamithason sodium phosphate. [DSP] Incupsulent in red blood cells), AT patients.
Participants will be made random (1: 1) between the EDSP or Placebo, and the treatment will have six infusion once every 21 to 30 days. According to the SPA agreement with the FDA, compared to the Placebo compared to the Placebo compared to the Placebo compared to the Placebo compared to the Placebo, the closing point of the basic utility will be measured from the baseline to the last tour.
Pipeline and corporate updates
Create Phase 2 Clinical Test Studies that are designed to evaluate EDSP for potential treatment of Duchin muscle dystrophy (DMD) patients. Queens plans to start a study of DMD Phase 2 in 2025, which the company expects to use effective capital study methods and financially support grants and/or opportunistic funding opportunities.
Published long -term protective data from patients treated with EDSP in at least 24 months Frontiers in neurology In January 2025. Is the title of online publication Dexamithason sodium phosphate’s long-term safety covers ataxia-telangiectasia includes atotolagus irrititisis in pediatric patients Can be accessed Here.
Dr. William White House, the Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham, and notingham Children’s Hospital, NHS Trust at Nottingham University Hospitals, the company’s Scientific Advisory Board (SAB) recently retired.
In February 2025, with the issuance of the US Patent and Trade Mark Office (USPTO) allowance notices, the growing partfolio and long -term market position of the growing intellectual property was strengthened. This has increased the company’s patent claims in the United States to 2036 in 2036, and its current US patent with its current US patent has been presented with propaganda claims that use patients with treatment patients with treatment patients.
In February 2025, an investor was organized in which the key opinion leader (KOL) Dr Maryam Koenig was included in Athelth Houston, focusing on resolving the highest need for AT. During the investor webnar, Dr. Coenig 1) presented a natural history review, 2) Detailed approach to current symptomatic treatment for AT patients discussed competitive treatment in the landscape, and 4) Clean -3 -EDSP’s cleaning of Queens Phase 3 EDSP’s Clean Clean Clean Clean. A replay of Coal Investor Webinar is available Here.
Fiscal year 2024 operating highlights
In June 2024, the FDA was given the FDA for the Queens EDSP system for the treatment of AT patients.
The EDSP examination for AT treatment in the Medical Journal company Phase 3 related utility and safety results Lancet neurology.
Participated in remarkable scientific meetings, including poster presentations in 53RD The Child Neurology Society (CNS) Annual Meeting and the 2024 International Congress for Atexia Research (ICAR), where Queens presented data from their Phase 3 clinical trials.
IQVIA Medical Claims (DX), Pharmetricsplus (P+), and IQVIA completed the first -party sizing project based on the third -party analysis of IQVIA analytics, which confirmed that the number of patients diagnosed with AT in the United States is estimated at about 4,600.
Established an SAB consisting of leading experts in biochemistry, neurology, immunology, hematology, pharmacology, and clinical practice, which is placed individually to provide deep insights and advice to support the development of the company’s drug programs.
Fiscal Year 2024 financial results
Cash, cash equations, and a short -term investment of $ 40.8 million have been reported for the financial year ending December 31, 2024. Queens expects its current cash runway phase 3 clean topline results to fund the company’s capital’s efficient development project and plans to become opportunities from the company’s financing approach to expand the company’s current cash runway in 2026.
Research and Development (R&D) costs for the financial year ending December 31, 2024 (R&D) costs $ 18.6 million.
The costs of General and Administrative (G&A) for the financial year ended December 31, 2024.6 17.6 million.
For the financial year ending December 31, 2024, a net loss of 56.8 million, or a net loss per basic and thin share of $ 1.31. The average shares of the residual weight for the year were 43.3 million.
For the year ended December 31, 2024, net cash used in operating activities of 31.9 million has been reported. The cash used in operating activities was mainly due to a net loss of 56.8 million. The non -cash was adjusted for $ 25.4 million, which included a change of $ 4.7 million, a change of $ 4.7 million, a change of $ 4.7 million, $ 4.7 million, a change of $ 4.7 million. The reasonable price of long -term loan, and a net increase of 6 2.6 million in operating assets, which has a net increase in payable accounts, and costs and other current liabilities of 1 2.1 million.
In the third quarter of 2024, the second quarter of 2024 was paid in cash to the Ardal shareholders in the third quarter of 2024, in the third quarter of 2024.
About Queens Treatment
Queens therapatics, Inc. (NESDK: QNCX) is a long -step biotechnology company that is dedicated to opening the patient’s own biology strength to treat rare diseases. For more information about the company and its latest news, visit www.quincetx.com And follow the Queens on social media platforms LinkedFor, for, for,. FacebookFor, for, for,. XAnd UTube.
Forward -looking statements
The statements in this news release include the “forward -looking statements” in the sense of the private securities litigation Reform Act 1995, as included in Section 27A of the Securities Act of the Securities Act of 1933, and the Securities Exchange Act 1934, which is amended by the section 21, the section 21. In addition to historical facts, all statements may be future statements. The future statements included in this news release indicate “” “,” “”, “” expectation, “” “plan,” “belief,” “” “” “” “” “” “” “” “” “,” “” “” “” ” Examples of future -visible statements, among others, including clinical trials and relevant data results, success and reporting statements, including the ability to register the projects and participants, the behavior, and/or the current and additional studies. Expected cash position and operating runway; Extra funding and financial support, including grants or opportunistic funding opportunities. EDSP’s current and future clinical growth, including attexia-teilingiatasia (AT), Duchin Muscle Detrophy (DMD), and other potential treatment. The way to strategic development for EDSP; Planned Regulatory Agency’s requests and clinical trials and timelines, possibilities, and milestones expectations. And the potential benefits of EDSP and company market opportunities. The forward -looking statements are based on the current expectations of Queens and are subject to hereditary uncertainty, risks and assumptions that are difficult to predict and the company’s expectations can lead to the actual results differently. Moreover, some future visible statements are based on assumptions, such as future events that may not be true. Factors that may make the difference in the actual results include, but are not limited to, which on November 13, 2024, filed with the Securities and Exchange Commission (SEC), the company’s quarterly report on the KV, titled “Risk Factors”, and other reports, and other reports, and other reports. The statements waiting for the future in this news release are made according to this date, and Queens has not taken any duty to update such information under the applicable law.
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