Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results
- Successfully shifted strategic focus to Phase 3 development with the acquisition of EryDel S.p.A.
- Expect to complete Phase 3 clinical trial for EryDex with $75.1 million in cash on hand.
- NEAT clinical trial for A-T patients on track for enrollment with potential NDA submission in 2026.
- Exploring new indications for EryDex and potential applications of AIDE technology platform.
- Strong cash position to support clinical milestones and potential strategic partnerships for global expansion.
- None.
Insights
The recent update from Quince Therapeutics, Inc. regarding their cash position and progress in the development pipeline is a significant indicator of their strategic direction and financial health. With a robust cash reserve of $75.1 million, the company appears well-capitalized to pursue the completion of the Phase 3 NEAT clinical trial. This financial buffer is essential as clinical trials are cash-intensive and the risk of dilutive financing is a concern for investors. The focus on a late-stage asset, EryDex, for a condition with no approved treatments, represents a potential first-mover advantage in a market with a sizeable patient population. However, the projected timeline for topline results in the second half of 2025 and a potential NDA submission in 2026 indicates a long investment horizon, which may test the patience of stakeholders looking for quicker returns. Moreover, the company's intention to out-license regional territories could provide non-dilutive financing and validate the commercial potential of EryDex.
The therapeutic focus on Ataxia-Telangiectasia (A-T) using EryDex is a noteworthy development in the field of rare diseases. A-T is a debilitating condition and EryDex's approach, leveraging the Autologous Intracellular Drug Encapsulation (AIDE) technology, is innovative as it aims to improve drug delivery and reduce side effects associated with corticosteroids. The use of a patient's own red blood cells could potentially offer a better safety profile and efficacy, which is important for chronic treatments. The market opportunity for A-T, estimated at $1+ billion, is substantial, but the company's success hinges on the clinical trial outcomes. The decision to measure efficacy using the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) is an appropriate choice for capturing the neurological impact of the treatment. The extension of this technology to other rare diseases could further bolster the company's pipeline and market potential, but this expansion requires a careful assessment of the competitive landscape and the unmet medical needs in those areas.
Quince Therapeutics' strategic pivot to a Phase 3 biotechnology company and the acquisition of EryDel S.p.A. indicate a clear pathway towards commercialization, which is a positive signal for market analysts. The company's proprietary AIDE technology platform presents an opportunity to create a differentiated product portfolio. The Special Protocol Assessment (SPA) agreement with the FDA for the NEAT trial is a important regulatory milestone that may reduce the risk of regulatory setbacks and streamline the path to potential approval. The estimated patient population of 10,000 in the U.S., U.K. and EU4 countries may seem modest, but for rare diseases, this is a significant number that could translate into a strong demand for an approved therapy. The company's plan to engage with global patient advocacy groups and participate in scientific congresses is a strategic move to build awareness and support within the A-T community, which could be essential for trial recruitment and eventual product adoption.
“With the acquisition of EryDel S.p.A. in October last year, we have successfully shifted our strategic focus to become a Phase 3 biotechnology company dedicated to securing regulatory approval for our lead product, EryDex, for the treatment of patients with Ataxia-Telangiectasia (A-T),” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer. “With
Pivotal Phase 3 NEAT Clinical Trial
- Completed the majority of study start up activities related to the company’s pivotal Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; IEDAT-04-2022/NCT06193200) clinical trial.
- NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
- On track to meet expectations to begin enrollment in the NEAT study during the second quarter of 2024.
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Pivotal Phase 3 NEAT clinical trial will be conducted under a Special Protocol Assessment (SPA) agreement with the
U.S. Food & Drug Administration (FDA).
- Plan 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.
- Participants will be randomized (1:1) between EryDex 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 rescored modified International Cooperative Ataxia Rating Scale (RmICARS).
- Participants who complete the full treatment period, complete study assessments, and provide informed consent will be eligible to transition to an open label extension study.
- Expect to report Phase 3 NEAT topline results in the second half of 2025 with a potential NDA submission in 2026, assuming positive study results.
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Quince estimates there are an aggregate of approximately 10,000 patients with A-T in the
U.S. ,U.K. , and EU4 countries.
-
There are currently no approved therapeutic treatments for A-T and the market represents a
$1 + billion peak commercial opportunity globally based on the company’s internal estimates and assumptions.
Scientific, Pipeline, and Corporate Updates
- Detailed EryDex’s optimized delivery of DSP encapsulated in red blood cells with a comparison of company data relative to published corticosteroid pharmacokinetic and biodistribution information. Red blood cells have several characteristics that make them a potentially ideal vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Learn more here.
- Intend to investigate other potential indications for EryDex where chronic corticosteroid treatment is – or has the potential to become – a standard of care if there were not corticosteroid-related safety concerns. This evaluation process is expected to span across ataxias, neuromuscular indications, hematology, cancer, and autoimmune diseases, with a focus on rare diseases.
- Plan to evaluate additional potential applications of Quince’s proprietary AIDE technology platform using drugs and biologics targeted at rare and debilitating diseases to further expand the company’s drug development pipeline.
- Targeting participation at several A-T related global ataxia and neurology scientific congresses in 2024, in addition to ongoing engagement of global patient advocacy groups as enrollment of the Phase 3 NEAT study progresses.
Strong Cash Position Expected to Support Meaningful Clinical Milestone
-
Reported
$75.1 million
-
Expect to fully fund lead asset, EryDex, through Phase 3 NEAT topline results and prepare for a potential NDA submission in 2026, assuming positive study results. This includes approximately
$20 million $15 million
-
Evaluate potential strategic partnerships to out-license ex-
U.S. regional territories to extend operational runway to support potential NDA approval of EryDex, as well as further advance other potential indications and programs discovered using the AIDE platform.
About Quince Therapeutics
Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the potential of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, and Twitter/X.
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 current and future clinical development of EryDex, including a pivotal trial for Ataxia-Telangiectasia, potential commercial-stage inflection point for EryDex, and expansion of the company’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology for treatment of other rare diseases; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the clinical trials and related data, including plans and the ability to initiate, fund, conduct, and/or complete current and additional studies; research and development costs; the company’s future development plans and related timing; cash position and projected cash runway; the company’s focus, objectives, plans, and strategies; 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 14, 2023, 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/20240329372032/en/
Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
ir@quincetx.com
Source: Quince Therapeutics, Inc.
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