Quince Therapeutics, Inc. (QNCX)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was primarily defined by a strategic decision to potentially conclude Phase 3 NEAT enrollment early by end-June 2025 to align topline timing with cash runway; this shifts topline results from prior guidance of Q4 2025 to early 2026 and targets ~80% power on the primary endpoint .
• Financially, Quince reported cash, cash equivalents, and short-term investments of $31.6M, R&D of $8.1M, G&A of $4.8M, and net loss of $15.0M (EPS -$0.34) for Q1; operating cash burn was $9.6M .
• Versus Wall Street consensus, Q1 EPS missed: -$0.34 actual vs -$0.2275 consensus; revenue remains pre-commercial with consensus at $0.0 [Values retrieved from S&P Global].
• Clinical execution KPIs remained solid: 63 participants enrolled (56 in primary analysis cohort), 19 sites activated, 80 screened with a 10% screen failure rate, and all 30 completers transitioned to OLE, supporting data integrity and continuity .
• Subsequent to quarter end, Quince priced a private placement for $11.5M upfront (up to $22M including warrants), extending runway into Q2 2026 (or H2 2026 if warrants are fully exercised), which should de-risk development timelines and catalyze investor focus on NEAT readout path .

What Went Well and What Went Wrong

What Went Well

• Operational quality in NEAT remained high with limited withdrawals, low missing data and procedural deviations, and universal OLE transition among completers, bolstering trial integrity and potential approvability narrative .
• Site footprint expanded across U.K. and Europe and near-term screening expected to pick up due to recent activations, with seven participants set for screening and total screened reaching 80 with a low 10% screen failure rate .
• IP strengthened: USPTO Notice of Allowance broadens EryDex method-of-use protection to 2036 and supports Orange Book listing, enhancing long-term exclusivity and potential barriers to generic entry .

What Went Wrong

• Enrollment slowed versus expectations due to a challenging academic site environment, prompting consideration of early enrollment conclusion below the original target of 86 six-to-nine-year-old patients, and pushing topline from Q4 2025 to early 2026 .
• Higher R&D spend in Q1 ($8.1M) contributed to a larger net loss (-$15.0M) and EPS (-$0.34) versus the prior-year quarter (-$11.1M, -$0.26), reflecting the ramp in Phase 3 trial activity .
• No earnings call transcript was available for Q1 2025, limiting visibility into management’s real-time Q&A clarifications on trial design, power, and timeline trade-offs [ListDocuments returned none].

Financial Results

Notes: “n/a” indicates not disclosed in available primary sources for that quarter. Q4 2024 EPS actual shown via S&P Global data (-$0.28)* [Values retrieved from S&P Global].

Prior-year comparison (Q1 2024):

• R&D: $3.7M; G&A: $5.0M; Total Opex: $11.2M; Net loss: $11.15M; EPS: -$0.26 .

KPIs (Clinical Execution)

Guidance Changes

Earnings Call Themes & Trends

Note: No earnings call transcript was available for Q1 2025.

Management Commentary

• “Quince has made the strategic business decision to potentially conclude enrollment of our pivotal Phase 3 NEAT clinical trial early by the end of June 2025… The combination of these factors leads us to now consider concluding enrollment prior to reaching the pre-specified target of 86 patients in the primary analysis population.” — Dirk Thye, M.D., CEO & CMO .
• “This timeline would allow the company to report topline results by early 2026 while maintaining a positive cash balance. Assuming positive results… we plan to submit applications for approval in the U.S. and Europe in the second half of 2026.” — Dirk Thye, M.D. .
• “We continue to make significant progress with clinical site activations and enrollment… We anticipate completing enrollment during the second quarter of 2025 and reporting topline results before the end of 2025.” — prior guidance, Feb 7 webinar .

Q&A Highlights

• No Q1 earnings call transcript was available; therefore, no Q&A highlights or clarifications can be cited from a live discussion [ListDocuments returned none].

Estimates Context

Notes: Asterisk (*) denotes values retrieved from S&P Global. Actual EPS for Q3 2024 and Q1 2025 is from company materials . Revenue remains pre-commercial; actual revenue was not disclosed in primary sources for these quarters.

Key Takeaways for Investors

• Strategy shift to conclude NEAT enrollment early balances power (~80%) with runway, pushing topline to early 2026; this reduces near-term timeline risk while preserving statistical rigor .
• Operational execution remains strong (low missing data, universal OLE transitions), underwriting trial quality and potential regulatory acceptability of data .
• Q1 cash of $31.6M and burn of ~$9.6M OCF provide visibility; subsequent $11.5M financing extends runway into Q2 2026/H2 2026 if warrants are exercised, lowering financing overhang into topline .
• EPS missed consensus in Q1; opex ramp (R&D $8.1M) reflects trial activity; expect continued R&D weighting until NEAT completion [Values retrieved from S&P Global].
• IP expansion (USPTO allowance to 2036) and Fast Track status strengthen defensibility and potential commercial path upon positive readout .
• Near-term catalysts: enrollment decision by end-June 2025, incremental site activations/screening updates, financing close, and continued OLE progression—each a potential stock narrative driver .
• Medium-term: topline in early 2026 and planned NDA/MAA filings in 2H 2026; positioning will hinge on magnitude of clinical benefit on RmICARS and safety consistency relative to historical datasets .

Citations:

• Q1 2025 Press Release and 8-K:
• Prior quarters and Q1-related press releases:
• Financing (post-quarter):

S&P Global disclaimer: Estimate values marked with an asterisk (*) are retrieved from S&P Global.