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Grace Therapeutics, Inc. (GRCE)·Q1 2026 Earnings Summary

Executive Summary

  • Q1 2026 delivered a modest beat on EPS versus Street, driven by lower R&D spend post Phase 3 STRIVE-ON trial completion and stable G&A; GAAP diluted EPS was $(0.21) vs consensus $(0.23)*, and net loss was $3.4M .
  • The company submitted its NDA for GTx-104 for aSAH; FDA’s 60‑day acceptance window began, with potential $7.6M warrant exercises tied to acceptance, strengthening liquidity optionality .
  • Cash and equivalents were $20.0M at quarter‑end, down ~$2.1M QoQ, with runway through at least the next 12 months; runway could extend into Q2 2027 if 2023 and 2025 warrants are exercised .
  • Strategic narrative continues to center on regulatory progress and pharmacoeconomic benefits for GTx‑104; no product revenue reported, consistent with late‑stage status .

What Went Well and What Went Wrong

What Went Well

  • NDA for GTx‑104 submitted, a key de‑risking milestone: “Our NDA is supported by a robust data package including positive results from our STRIVE‑ON trial…” .
  • Operating discipline: R&D fell to ~$0.9M with trial completion, contributing to EPS beat vs consensus .
  • Liquidity flexibility: Potential warrant exercises ($7.6M from 2023, $15.0M from Feb 2025) could extend runway into Q2 2027 .

What Went Wrong

  • Net loss increased YoY to $3.4M, primarily due to derivative warrant liability fair‑value changes and lower tax benefit, partly offset by lower R&D .
  • Cash used increased QoQ (cash down ~$2.1M), reflecting operating needs as the company advances regulatory filing and pre‑commercial work .
  • No commercial revenue, and therefore no margin structure; value drivers remain binary and tied to FDA timelines and eventual launch execution .

Financial Results

Income Statement and Cash KPIs (oldest → newest)

MetricQ2 2025Q3 2025Q1 2026
Diluted EPS ($)$(0.30) $(0.36) $(0.21)
Net Loss ($USD Millions)$3.43 $4.16 $3.36
R&D Expense ($USD Millions)$2.98 $2.19 $0.96
G&A Expense ($USD Millions)$1.86 $1.51 $2.14
Cash & Equivalents ($USD Millions)$15.16 $11.06 $20.01
Weighted Avg Shares (Millions)11.51 11.51 15.92

Notes:

  • No product revenue reported in these periods; statements are expense‑driven .
  • Cash at March 31, 2025 (prior quarter reference): $22.13M .

Estimates vs Actuals – Q1 2026

MetricConsensusActual
EPS ($)$(0.23)*$(0.21)
EBITDA ($USD Millions)$(3.60)*$(3.09)*
Revenue ($USD Millions)$0.00*N/A (no product revenue)

Values marked with * retrieved from S&P Global.

KPIs and Liquidity

KPIQ1 2026
Derivative Warrant Liabilities ($USD Millions)$1.63
Potential Warrant Proceeds – Feb 2025 ($USD Millions)$15.0 (exercise price $3.395)
Potential Warrant Proceeds – Sep 2023 ($USD Millions)$7.6 (exercise price $3.003)
Cash Runway Commentary≥12 months; could extend into Q2 2027 upon warrant exercise

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Regulatory – NDA TimingH1 CY2025File by end of June 2025 NDA submitted June 25, 2025 Achieved milestone
Regulatory – FDA Acceptance Window~60 days post‑filingNot explicitly stated priorFDA typically 60‑day acceptance review Formalized timeline
Liquidity – Cash RunwayMulti‑periodInto Q3 CY2026 ≥12 months; potentially to Q2 CY2027 upon warrant exercises Clarified; extended contingent on warrants
Revenue, Margins, OpEx, TaxQ1 2026None providedNone providedMaintained “no quantitative guidance” stance

Earnings Call Themes & Trends

(No Q1 2026 earnings call transcript was available in our document catalog. MarketBeat listed a call time, but no transcript was found) .

TopicPrevious Mentions (Q3 2025)Previous Mentions (Q4 FY2025)Current Period (Q1 2026)Trend
Regulatory progress (NDA for GTx‑104)STRIVE‑ON met primary endpoint; NDA targeted H1 CY2025 Type C meeting held; aligned with FDA; NDA on track by end of June 2025 NDA submitted; FDA acceptance window outlined Advancing; milestone achieved
Clinical data (STRIVE‑ON outcomes)Positive topline emphasizing hypotension reduction, dose compliance, functional outcomes Reiterated endpoints and pharmacoeconomic benefits Reaffirmed clinical and economic benefits; supports NDA Consistent reinforcement
Liquidity and warrantsPrivate placement $15M upfront; potential +$15M warrants Reiterated $15M warrants (Feb 2025) and $7.6M warrants (Sep 2023) Detailed warrant triggers tied to NDA acceptance/approval Increasing optionality
Commercial planningFunding to support pre‑commercial planning Pre‑commercial and CMC readiness emphasized GTx‑104 commercial assessment costs noted Building infrastructure
Portfolio focus (GTx‑102, GTx‑101)GTx‑102 received FDA feedback; others deprioritized GTx‑102/101 deprioritized; potential license/sale Continued deprioritization; potential license/sale Stable focus on GTx‑104

Management Commentary

  • “During our first quarter of 2026 we continued to execute on our clinical and corporate goals, led by the submission of our NDA to the FDA for GTx‑104…” — Prashant Kohli, CEO .
  • “Our NDA is supported by a robust data package including positive results from our STRIVE‑ON trial… We are hopeful the FDA will accept our NDA for formal review…” — Prashant Kohli, CEO .
  • On alignment with FDA ahead of submission: “…we are pleased to achieve alignment with the agency on the substance and structure of our NDA submission…” — Prashant Kohli, CEO .
  • On STRIVE‑ON differentiation: “GTx‑104 had fewer patients with clinically significant hypotension, more patients with higher dose compliance and better functional recovery, and lower pharmacoeconomic burden.” .

Q&A Highlights

  • No Q1 2026 earnings call transcript available; we did not locate a transcript in filings or public sources. MarketBeat lists a call time, but no transcript link was found .
  • Guidance clarifications and detailed Q&A themes therefore were not available from a transcript.

Estimates Context

  • EPS beat: $(0.21) actual vs $(0.23) consensus*, a ~$0.01 beat, largely aided by lower R&D and steady G&A .
  • EBITDA beat: $(3.09) actual* vs $(3.60) consensus*, reflecting operating expense moderation post trial completion.
  • Revenue: Consensus $0.00* and no product revenue reported, consistent with late‑stage status .
  • Target Price Consensus Mean: $11.74*; no consensus recommendation text available*.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory milestone achieved with NDA submission; the near‑term catalyst is FDA’s 60‑day acceptance decision, which could unlock $7.6M from 2023 warrants and later $15.0M from 2025 warrants upon approval .
  • Cost profile is transitioning post Phase 3 completion—R&D down to ~$0.9M; watch G&A as commercial assessment and team buildout proceed .
  • Liquidity is adequate with $20.0M cash and potential warrant inflows, supporting runway ≥12 months and potentially into Q2 2027 upon exercise .
  • STRIVE‑ON data continue to underpin differentiation (less hypotension, higher dose compliance, better functional outcomes), strengthening the clinical and pharmacoeconomic narrative ahead of potential launch .
  • With no product revenue or margin structure yet, stock moves will be event‑driven (NDA acceptance, review progress, labeling); monitor FDA interactions and any updates to commercial timelines .
  • Shares outstanding increased QoQ (15.92M weighted average), which investors should factor into per‑share modeling .
  • Near‑term estimate revisions likely modest: EPS/EBITDA may trend with operating spend cadence; major Street changes hinge on regulatory outcomes and commercialization visibility*.

Additional source documents referenced:

  • Q1 2026 earnings press release and tables (Item 2.02; Exhibit 99.1) .
  • NDA submission press release (June 25, 2025) .
  • FDA alignment press release (April 9, 2025) .
  • Prior quarters’ earnings releases and tables (Q3 2025; Q2 2025) .