Quince Therapeutics Provides Business Update and Reports Third Quarter 2024 Financial Results
13 Novembre 2024 - 10:05PM
Business Wire
Phase 3 NEAT clinical trial on track with 32
patients enrolled to date with majority of U.S. and European study
sites now enrolling patients
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, 2024.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “We are pleased to report accelerating
enrollment of our pivotal Phase 3 NEAT clinical trial in
Ataxia-Telangiectasia (A-T). As of today, we have enrolled 32
patients with A-T across clinical sites in the U.S., U.K., and
European Union. Additionally, the majority of planned NEAT study
sites are now activated and open for enrollment. We expect
enrollment momentum to continue as we work toward our commitment to
complete enrollment in the second quarter of 2025 and report
topline results in the fourth quarter of 2025.”
Pivotal Phase 3 NEAT Clinical Trial
- Enrolled 32 participants to date in the company’s Phase 3 NEAT
(Neurologic Effects of EryDex on Subjects with
A-T; IEDAT-04-2022/NCT06193200) clinical trial
to evaluate the neurological effects of EryDex in patients with
A-T.
- 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.
- 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, which will begin in
the fourth quarter of 2024.
- 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, 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.
- 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 a rescored
modified International Cooperative Ataxia Rating Scale (RmICARS)
compared to placebo as per the SPA agreement with the FDA.
Pipeline and Corporate Updates
- Participation at scientific congresses, including a poster
presentation of safety data from the previously completed ATTeST
study at the 53rd Child Neurology Society Annual Meeting. Quince is
also sponsoring and participating at the 2024 International
Congress for Ataxia Research in November 2024 with two poster
presentations, including growth and bone mineral density in
patients with A-T treated with EryDex, and an analysis of the
International Cooperative Ataxia Rating Scale (ICARS) subcomponent
scores in patients with A-T.
- Generating Phase 2 clinical trial study designed to evaluate
EryDex for the potential treatment of patients with Duchenne
muscular dystrophy (DMD), including those with corticosteroid
intolerance, who represent the majority of the DMD population.
Quince plans to initiate a DMD Phase 2 study in 2025, which the
company expects to conduct utilizing capital efficient study
approaches.
- Completed evaluation process of other potential rare disease
indications beyond A-T and Duchenne muscular dystrophy 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. The prioritized list of
other potential rare disease targets under consideration includes:
1) autoimmune hepatitis, 2) dermatomyositis, 3) pemphigus vulgaris,
4) Hashimoto's encephalopathy, 5) Becker muscular dystrophy, 6)
pediatric lupus, 7) juvenile idiopathic arthritis, 8) myasthenia
gravis, 9) limb-girdle muscular dystrophy, 10) chronic inflammatory
demyelinating polyradiculoneuropathy, and 11) pulmonary
sarcoidosis.
Third Quarter and Year-to-Date 2024 Financial Results
- Reported cash, cash equivalents, and short-term investments of
$47.8 million for the third quarter ended September 30, 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.
- Expect strong cash position to fully fund lead asset, EryDex,
through Phase 3 NEAT topline results in the fourth quarter of 2025
and prepare for NDA and MAA submissions in 2026, assuming positive
study results. This includes approximately $20 million for the NEAT
clinical trial and approximately $15 million in direct trial costs
for an open label extension study.
- Reported research and development (R&D) expenses of $4.9
million for the third quarter ended September 30, 2024. R&D
expenses during the quarter primarily included costs related to
ongoing Phase 3 NEAT clinical trial activities and related
manufacturing costs.
- Reported general and administrative (G&A) expenses of $3.6
million for the third quarter ended September 30, 2024. G&A
expenses for the quarter 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 $5.5 million, or a net loss of $0.13 per
basic and diluted share, for the third quarter ended September 30,
2024. Weighted average shares outstanding for the quarter were 43.2
million.
- Reported net cash used in operating activities of $24.4 million
for the nine months ended September 30, 2024, which included a net
loss of $44.4 million for the period, adjusted for $22.4 million of
non-cash items, including $17.1 million goodwill impairment charge,
$2.1 million change in the fair value of contingent consideration
liabilities, $3.6 million in stock-based compensation, a net
increase in operating assets of $2.5 million, and a net increase in
accounts payable, accrued expenses, and other current liabilities
of $0.1 million. Additionally, Quince made a cash milestone payment
of $5 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 current and future clinical
development of EryDex, including for the potential treatment of
Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and
other potential indications, related development and
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, success, and reporting of
results of the clinical trials and related data, including plans
and the ability to initiate, fund, enroll, 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 potential benefits of
EryDex, AIDE technology 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 August 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241113919574/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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