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Quince Therapeutics, Inc. (QNCX)·Q3 2024 Earnings Summary

Executive Summary

  • Reported Q3 2024 net loss of $5.49M and diluted EPS of $0.13 loss; total operating expenses were $5.86M as Quince continues to be pre-revenue . Cash, cash equivalents, and short-term investments were $47.8M, with runway expected through NEAT topline results and into 2026 .
  • NEAT Phase 3 enrollment accelerated to 32 patients, with the majority of U.S. and European sites now open; management reiterated completion of enrollment in Q2 2025 and topline in Q4 2025 .
  • Q3 R&D of $4.9M and G&A of $3.6M reflect ongoing trial activities and disciplined spend; net loss narrowed sharply vs Q2 due to the absence of goodwill impairment in Q3 (Q2 included a $17.1M non-cash impairment) .
  • Additional Q3 catalysts: safety and efficacy validation via CNS and ICAR posters from prior ATTeST study; Fast Track designation (granted in Q2) supports expedited regulatory engagement .

What Went Well and What Went Wrong

What Went Well

  • Enrollment momentum: “We are pleased to report accelerating enrollment of our pivotal Phase 3 NEAT clinical trial… majority of planned NEAT study sites are now activated and open for enrollment” .
  • Safety profile reinforced: Prior ATTeST safety analysis showed EryDex was generally well tolerated with mild-to-moderate transient TEAEs and no typical chronic steroid side effects (e.g., Cushingoid features, hyperglycemia) .
  • Funding visibility: $47.8M in cash/short-term investments; management expects runway to fund NEAT topline and into 2026 (including ~$20M NEAT and ~$15M OLE direct costs) .

What Went Wrong

  • Ongoing losses: Net loss of $5.49M with no revenue recognized, underscoring continued dependence on external funding until approval/commercialization .
  • Balance sheet overhangs: Fair value adjustments on debt and contingent consideration persist; Q3 included a $(0.449)M debt fair value hit, highlighting financing-related non-cash volatility .
  • Prior-quarter impairment: Q2 recorded a $17.1M non-cash goodwill impairment due to market cap vs carrying value, reminding of valuation sensitivity and execution risk in the pivotal program .

Financial Results

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Revenue ($USD Millions)$0.0 (no revenue line) $0.0 (no revenue line) $0.0 (no revenue line) $0.0 (no revenue line)
Total Operating Expenses ($USD Millions)$6.09 $11.22 $28.19 $5.86
R&D Expense ($USD Millions)$1.43 $3.70 $4.15 $4.92
G&A Expense ($USD Millions)$4.66 $4.97 $4.70 $3.63
Loss from Operations ($USD Millions)$(6.09) $(11.22) $(28.19) $(5.86)
Interest Income ($USD Millions)$0.96 $0.89 $0.82 $0.68
Net Loss ($USD Millions)$(5.35) $(11.15) $(27.73) $(5.49)
Diluted EPS ($USD)$(0.15) $(0.26) $(0.64) $(0.13)
Cash & Short-term Investments ($USD Millions)N/A$67.8 $59.4 $47.8

Segment breakdown: Quince operates as a single reportable segment focused on developing and commercializing therapeutics .

KPIs and Operating Metrics

KPIQ3 2023Q1 2024Q2 2024Q3 2024
NEAT Enrollment (patients)N/AEnrollment planned to begin Q2 2024 7 patients enrolled to date 32 patients enrolled to date
Sites Activated (status)N/AStart-up activities targeted by Q2 2024 U.S., U.K., EU sites enrolling Majority of planned sites open
Operating Cash Outflows (period cash used, $USD Millions)N/A$(8.35) (Q1) $(17.09) (H1) $(24.40) (9M)
Weighted Avg Shares (Millions)36.07 43.01 43.10 43.16

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NEAT Enrollment CompletionQ2 2025Complete enrollment H1/Q2 2025 Complete enrollment Q2 2025 Maintained (clarified timing)
NEAT Topline ResultsQ4 2025Topline in H2/Q4 2025 Topline Q4 2025 Maintained
Open Label Extension (OLE) StartQ4 2024OLE eligibility after treatment; start implied post initial period OLE begins Q4 2024 New/Specified timing
DMD Study Initiation2025Proof-of-concept study in 2025 Phase 2 study initiation in 2025 (capital efficient design) Maintained (design clarified)
Cash RunwayThrough topline and into 2026Sufficient runway into 2026 Runway through NEAT topline and into 2026 Maintained
NEAT/OLE Direct Trial Costs2024–2026Not quantified~$20M (NEAT) and ~$15M (OLE) direct trial costs New quantified cost detail

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory status (SPA, Fast Track)SPA for NEAT; FDA Fast Track granted in Q2 Continues under SPA; Fast Track referenced Stable, supportive
R&D execution (NEAT progress)Start-up activities; first patient dosed; 7 enrolled 32 enrolled; majority sites active; OLE start Q4 2024 Improving/accelerating
Clinical evidence (ATTeST learnings)Leveraging ATTeST dataset context Safety poster (CNS) and BMD/mICARS/ RmICARS analyses (ICAR) Reinforcing safety/endpoint validation
Pipeline expansion (DMD)Planning PoC; capital-efficient approaches Phase 2 DMD in 2025 (capital-efficient) Advancing planning
Financial runway & costsRunway into 2026 Runway through topline into 2026; cost detail added Maintained, more granular
Strategic partnershipsExploring ex-U.S. out-licensing Continued consideration (not updated explicitly in Q3 PR) Neutral

Management Commentary

  • “We are pleased to report accelerating enrollment of our pivotal Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T)… We expect enrollment momentum to continue… complete enrollment in the second quarter of 2025 and report topline results in the fourth quarter of 2025.” — Dirk Thye, M.D., CEO & CMO .
  • “Results from the ATTeST study… suggest that EryDex may be a promising therapy for patients with A-T… We are pleased to advance EryDex treatment in our pivotal Phase 3 NEAT study, currently enrolling… with topline results expected in the fourth quarter of 2025.” — Dirk Thye, M.D. (CNS safety poster) .
  • “We continue to gain valuable insights from the robust dataset provided from our prior Phase ATTeST clinical trial… showcase EryDex’s strong safety profile and provide validation of the primary efficacy endpoint utilized in our study.” — Dirk Thye, M.D. (ICAR posters) .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available in our document catalog; therefore, no Q&A themes were extractable for this period [ListDocuments earnings-call-transcript: 0 results].

Estimates Context

  • We attempted to retrieve S&P Global consensus for quarterly revenue and EPS for comparison to actuals, but estimates were unavailable due to data access limits at this time. As a result, estimate-based comparisons are not included (we searched for “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for last three quarters and next quarter, but SPGI returned a daily request limit error).

Key Takeaways for Investors

  • NEAT enrollment is accelerating (32 patients), de-risking execution toward Q2 2025 completion and Q4 2025 topline; continued site activation should sustain momentum .
  • Safety and endpoint validation from ATTeST-derived CNS/ICAR posters strengthen the clinical narrative ahead of pivotal readout; absence of typical chronic steroid side effects is notable for EryDex’s differentiation .
  • Cash of $47.8M and disclosed NEAT/OLE direct costs (~$35M) indicate runway through pivotal topline and into 2026, but financing needs remain likely for commercial readiness and broader pipeline expansion .
  • Financials show a significantly lower Q3 net loss vs Q2 due to non-recurrence of the goodwill impairment, but company remains pre-revenue; ongoing opex and financing-related fair value adjustments contribute to volatility .
  • Near-term catalysts: OLE initiation in Q4 2024, enrollment updates, DMD Phase 2 initiation planning in 2025, and continued regulatory interactions under Fast Track/SPA .
  • Medium-term thesis hinges on NEAT success and regulatory approvals; ex-U.S. out-licensing could be a lever to extend runway and fund indication expansion if executed .

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