Quince Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results
13 Agosto 2024 - 10:05PM
Business Wire
Strong cash position expected to provide
sufficient operating runway into 2026; Phase 3 topline results
expected in the fourth quarter of 2025
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,
2024.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “We achieved a major clinical milestone
during the second quarter of 2024 with the first patient enrolled
in our pivotal Phase 3 NEAT clinical trial in Ataxia-Telangiectasia
(A-T). As of today, we have enrolled seven patients with A-T across
clinical sites in the U.S., U.K., and European Union. We are
encouraged by this strong start and expect NEAT site activation and
patient screening activities to accelerate over the next
quarter.”
Pivotal Phase 3 NEAT Clinical Trial
- Dosed the first patient 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
in June 2024.
- Enrolled seven patients with A-T in the NEAT clinical trial to
date. 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.
- 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.
- Pivotal Phase 3 NEAT clinical trial is being conducted under a
Special Protocol Assessment agreement with the U.S. Food and Drug
Administration (FDA).
- 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.
- 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 fourth
quarter of 2025 with a potential 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.
Pipeline and Corporate Updates
- Granted Fast Track designation by the FDA for the company’s
EryDex System for the treatment of patients with A-T based on the
potential for EryDex to address a high unmet medical need in
A-T.
- Updated 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, an increase from previous estimates of approximately 3,400
diagnosed patients. 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.
- Generating proof-of-concept clinical trial study designs 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 proof-of-concept study
in 2025, which the company expects to conduct utilizing capital
efficient study approaches.
- Planned participation at upcoming scientific congresses,
including a poster presentation of EryDex safety data at the
upcoming 53rd Child Neurology Society Annual Meeting in November
2024. Quince will also be a sponsor of and participate 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.
- Strengthening of leadership team with the addition of Brent
Roeck as Vice President of Program and Alliance Management and
Katie George as Executive Director Clinical Operations, bringing
more than 50 years of collective experience across rare disease and
the pharmaceutical and biotech industry to support Quince’s pivotal
Phase 3 NEAT study and focus on strategic business
partnerships.
- Investigating 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.
- Evaluating potential strategic partnerships to out-license
ex-U.S. rights to extend operational runway to support potential
NDA approval of EryDex in the U.S., as well as further advance
other potential indications and programs using the company’s
proprietary Autologous Intracellular Drug Encapsulation (AIDE)
technology platform.
- Participating at the H.C. Wainwright 26th Annual Global
Investment Conference the week of September 9, 2024. A webcast of
the presentation will be accessible here.
Second Quarter and Year-to-Date 2024 Financial
Results
- Reported cash, cash equivalents, and short-term investments of
$59.4 million for the second quarter ended June 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 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 potential 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 $4.2
million for the second quarter ended June 30, 2024. R&D
expenses during the quarter primarily included start-up costs
related to Phase 3 NEAT clinical trial activities and related
manufacturing costs.
- Reported general and administrative (G&A) expenses of $4.7
million for the second quarter ended June 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 $27.7 million, or a net loss of $0.64
per basic and diluted share, for the second quarter ended June 30,
2024. During the quarter, Quince recognized a non-cash goodwill
impairment charge of $17.1 million as the quantitative analysis
resulted in the company's fair value being below its carrying
value. Weighted average shares outstanding for the quarter were
43.1 million.
- Reported net cash used in operating activities of $17.1 million
for the six months ended June 30, 2024, which included a net loss
of $38.9 million for the period, adjusted for $24.0 million of
non-cash items, including a $4.8 million change in the fair value
of contingent consideration liabilities, $2.5 million in
stock-based compensation, and a net decrease in current assets of
$2.3 million, offset by a net decrease in accounts payable, accrued
expenses, and other current liabilities of $0.1 million compared to
the same period last year.
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 May 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/20240813990780/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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