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QT

Quince Therapeutics, Inc. (QNCX)·Q4 2024 Earnings Summary

Executive Summary

  • Quince reported FY 2024 net loss of $56.8M and GAAP net loss per share of $1.31; year-end cash, cash equivalents, and short-term investments were $40.8M, with runway guided “through Phase 3 NEAT topline results and into 2026.”
  • NEAT Phase 3 enrollment advanced materially across 2024: 7 enrolled in Q2, 32 in Q3, and 61 randomized by the FY update; topline results remain targeted for Q4 2025 with NDA/MAA submissions in 2026, assuming positive outcomes.
  • Q4 2024 EPS missed S&P Global consensus (actual* −$0.28 vs estimate* −$0.175); Q3 beat (actual −$0.13 vs estimate* −$0.155). Revenue consensus was $0 across periods. * [GetEstimates]*
  • Management emphasized strong safety data (no chronic steroid toxicities/adrenal suppression across long-term cohorts), SPA design alignment on RmICARS, and cash discipline; investor communication substituted for a traditional earnings call via a Feb 7 KOL webinar and Feb 12 conference fireside.

Note: Values with asterisks (*) are retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • NEAT enrollment accelerated: 7 patients enrolled by Q2, 32 by Q3 (sites largely activated), and 61 randomized by the FY update; open-label extension transitions underway. “Recent and upcoming new site activations are expected to accelerate enrollment.”
  • Regulatory alignment and IP: SPA agreement with FDA for NEAT; FDA Fast Track designation (June 2024); USPTO Notice of Allowance extends claims to 2036, strengthening long-term position.
  • Safety and endpoint validation: Management cited long-term safety without chronic steroid toxicities/adrenal suppression and published analyses supporting RmICARS sensitivity in 6–9-year-olds; “We are pleased to share new analyses… that showcase EryDex’s strong safety profile and provide validation of the primary efficacy endpoint…”

What Went Wrong

  • Q4 EPS miss vs consensus: Primary EPS actual* −$0.28 vs estimate* −$0.175; ongoing operating losses reflect clinical and manufacturing spend as the company remains pre-revenue. [GetEstimates]*
  • Impairment and non-cash charges: FY 2024 included a $17.1M goodwill impairment and fair value adjustments to contingent consideration and debt, inflating GAAP loss measures.
  • Financing milestone outflow: A $5.0M cash milestone payment to EryDel occurred in Q3 2024 after first patient enrollment, contributing to cash utilization.

Financial Results

Quarterly Results and Consensus Comparison

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
GAAP EPS ($USD)−$0.64 −$0.13 —
Primary EPS actual* ($USD)—−$0.13−$0.28
Primary EPS consensus* ($USD)−$0.175−$0.155−$0.175
R&D ($USD Millions)$4.2 $4.9 —
G&A ($USD Millions)$4.7 $3.6 —
Cash, Cash Equivalents & ST Investments ($USD Millions)$59.4 $47.8 $40.8

Note: Values with asterisks (*) are retrieved from S&P Global.

FY Results

MetricFY 2023FY 2024
Total Operating Expenses ($USD Millions)$34.6 $57.3
Net Loss ($USD Millions)$31.4 $56.8
GAAP Net Loss per Share ($USD)−$0.84 −$1.31
Cash from Operations ($USD Millions)—−$31.9
Cash, Cash Equivalents & ST Investments ($USD Millions)$75.1 $40.8

EPS vs Consensus

PeriodPrimary EPS Consensus Mean*Actual*Beat/Miss
Q3 2024−$0.155−$0.13Beat*
Q4 2024−$0.175−$0.28Miss*
FY 2024−$1.2025−$0.9176Beat*
FY 2025E−$1.09333——

Note: Values retrieved from S&P Global.

KPIs (Clinical & Operating)

KPIQ2 2024Q3 2024Q4 2024/FY Update
NEAT patients enrolled/randomized7 enrolled 32 enrolled; majority sites active 61 randomized; 24 transitioned to OLE
Trial timingFirst patient dosed; topline guided Q4 2025 Enrollment momentum; topline guided Q4 2025 Enrollment completion targeted Q2 2025; topline Q4 2025
Cash runway guidanceInto 2026 Into 2026 Through NEAT topline and into 2026

Guidance Changes

MetricPeriodPrevious Guidance (Q3 2024)Current Guidance (Q4/FY Update)Change
NEAT enrollment completionQ2 2025“Commitment to complete enrollment in Q2 2025” “Expected enrollment completion in Q2 2025” Maintained
NEAT topline readoutQ4 2025“Topline results in Q4 2025” “Anticipated topline in Q4 2025” Maintained
NDA/MAA submission timing2026“NDA/MAA in 2026, assuming positive” “NDA/MAA in 2026, assuming positive” Maintained
Open Label Extension (OLE) startQ4 2024“OLE will begin in Q4 2024” 24 transitioned to OLE to date Progressed
DMD Phase 2 initiation2025“Plan to initiate DMD Phase 2 in 2025” “Plan to initiate DMD Phase 2 in 2025” (capital-efficient; grant/opportunistic funding) Maintained (with funding color)
Cash runwayThrough NEAT topline, into 2026“Into 2026” “Through Phase 3 NEAT topline results and into 2026” Maintained
IP protectionThrough 2036 (U.S.)—USPTO Notice of Allowance extends claims into 2036 New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2)Previous Mentions (Q-1)Current Period (Q4/FY Update)Trend
Trial enrollment & site activationFirst patient dosed; 7 enrolled; SPA; Fast Track 32 enrolled; majority sites activated; enrollment momentum 61 randomized; new sites to accelerate; completion targeted Q2 2025 Improving
Endpoint strategy (RmICARS)Alignment to modified scales; SPA noted Emphasis on 6–9-year-old sensitivity; gait/posture focus Continued emphasis on RmICARS under SPA, endpoint sensitivity affirmed via analyses Consistent
Safety profileLong-term safety references; no typical steroid toxicities (historical) Safety data at CNS; tolerability without typical steroid side effects Publication of long-term safety (Frontiers in Neurology, Jan 2025) Strengthening
Cash runway & discipline$59.4M; runway into 2026 $47.8M; runway into 2026 $40.8M; runway through topline & into 2026; opportunistic financing Stable with prudent spend
Regulatory postureSPA with FDA; Fast Track SPA reiterated SPA reiterated; NDA/MAA timeline 2026 Consistent
Additional indicationsDMD study design; broader rare disease list DMD Phase 2 planned; rare disease prioritization DMD Phase 2 planned for 2025 (grant/opportunistic funding) Advancing (funding-dependent)
External validationUpcoming scientific congresses CNS & ICAR safety/endpoint posters Endpoint validation and safety publications continue Accretive

Management Commentary

  • “Our Phase 3 pivotal NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized… topline results from the NEAT study are anticipated in the fourth quarter of 2025.”
  • “Existing cash position of $40.8 million expected to provide operating runway through Phase 3 topline results into 2026.”
  • On endpoint sensitivity and FDA alignment: “mICARS and RmICARS subcomponents… capture the fastest neurological symptom progression in patients with A‑T between the ages of six to 10 years.”
  • On long-term safety: “We now have data on 384 patients… many taking this monthly for years… we don’t have any signs… of chronic steroid toxicity or adrenal suppression.”
  • DMD expansion intent: “Quince plans to initiate a DMD Phase 2 study in 2025… utilizing capital efficient study approaches and with financial support from grant and/or opportunistic funding opportunities.”

Q&A Highlights

  • Endpoint rationale: FDA’s rescored modified ICARS (29 points weighted to gait/posture) to better reflect function; conversion from full ICARS is programmatic; clinically meaningful change in 6–9-year-olds demonstrated in ATTeST subgroup.
  • Safety/tolerability concerns: Conventional systemic steroids induce infections, bone health issues, adrenal suppression within months; EryDex approach seeks efficacy while avoiding chronic steroid toxicities.
  • Younger and older cohorts: EMA-requested pediatric plan (≈1–6 years; 30 mL process) targeted; inclusion of 10+ yrs in NEAT to support broader labeling in absence of safety signals.
  • Competitive landscape and combinations: Limited relevance of FA therapies (e.g., Skyclarys) to AT per pathophysiology; combinations speculative.

Estimates Context

  • Q4 2024 EPS missed consensus: Primary EPS actual* −$0.28 vs estimate* −$0.175; Q3 2024 beat: actual −$0.13 vs estimate* −$0.155; FY 2024 beat: actual* −$0.9176 vs estimate* −$1.2025. Revenue consensus was $0.0 across periods. [GetEstimates]*
  • Note on frameworks: S&P Global “Primary EPS” may differ from GAAP net loss per share (GAAP FY 2024 was −$1.31), reflecting normalization/non-GAAP adjustments; future revisions should reconcile investor models to GAAP/non-GAAP definitions. *

Note: Values retrieved from S&P Global.

Key Takeaways for Investors

  • Enrollment traction supports Q4 2025 NEAT topline timing; SPA alignment and endpoint sensitivity in the 6–9 cohort increase probability of a clear readout.
  • Financial runway into 2026 underpins execution through topline; opportunistic financing commentary suggests proactive extension potential without near-term distress.
  • Safety narrative continues to strengthen via publications and long-term patient experience—an important de-risking element given steroid class concerns.
  • Q4 EPS miss vs consensus is directionally unsurprising for a pre-revenue, R&D-intensive period; near-term stock catalysts skew to operational updates (enrollment completion Q2 2025, pediatric plan initiation, site activations). [GetEstimates]*
  • DMD Phase 2 remains a meaningful medium-term optionality lever contingent on funding, KOL alignment, and trial design—monitor grant/opportunistic funding milestones.
  • IP extension to 2036 and SAB adds structural and advisory durability ahead of potential NDA/MAA in 2026, assuming positive NEAT outcomes.
  • Trading implication: Near-term tape likely sensitive to enrollment pace and any regulatory/process updates; model estimates should be anchored to S&P consensus EPS while tracking GAAP vs normalized EPS disclosures. [GetEstimates]*