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Grace Therapeutics, Inc. (GRCE)·Q4 2025 Earnings Summary

Executive Summary

  • GRCE reported FY 2025 net loss of $9.6M ($0.79/share) as operating spend ramped for GTx-104; Q4 EPS printed positive at ~$0.10, a material beat vs consensus (-$0.28), and FY EPS also beat (-$0.75 vs -$1.15), reflecting non-operating gains and tax benefits as detailed in the release (estimates marked with asterisks from S&P Global: see tables).
  • Strategic progress was the highlight: FDA Type C feedback aligned on NDA contents, the NDA was filed June 25, and orphan exclusivity is in place; FDA has 60 days to determine filing acceptability, a near-term catalyst .
  • Liquidity runway now extends into Q3 CY2026, potentially to Q2 CY2027 if investors exercise outstanding warrants tied to NDA acceptance/approval; financing of $15M upfront (with up to $15M additional via warrants) supports pre-commercial buildout .
  • Investor focus is on NDA acceptance (60-day window) and review designation; warrant exercise tied to acceptance could add ~$7.6M, while separate 2025 warrants become exercisable upon approval, extending cash runway and reducing financing overhang .

What Went Well and What Went Wrong

What Went Well

  • FDA alignment on NDA submission content across clinical, non-clinical, and CMC; management: “positive and productive” interactions with the agency and “alignment” on NDA structure .
  • NDA filed for GTx-104 with a comprehensive package including Phase 3 STRIVE-ON safety data; CEO frames it as a “significant milestone” with evidence of improved clinical outcomes and potential pharmacoeconomic benefits vs oral nimodipine .
  • Financing flexibility and runway: $15M gross upfront financing in Feb 2025 with potential for an additional $15M from warrant exercises; plus $7.6M of 2023 warrants tied to FDA acceptance of the NDA could be exercised—runway into Q3 CY2026 (potentially Q2 CY2027) .

What Went Wrong

  • Operating spend stepped up meaningfully: FY25 R&D rose to $9.5M (from $4.7M) driven by STRIVE-ON; G&A also increased to $7.2M, reflecting legal/tax/professional fees around redomicile and staffing, contributing to ongoing losses .
  • STRIVE-ON mortality imbalance (8 deaths on GTx-104 vs 4 oral nimodipine; none deemed drug-related) could raise diligence questions despite safety comparability; management emphasizes no new safety issues and disease severity as cause .
  • Pre-revenue profile persists; no product revenues to offset burn, keeping the story binary around regulatory outcomes and necessitating continued focus on capital structure and warrant overhangs .

Financial Results

EPS vs Consensus (S&P Global)

MetricQ2 2025Q3 2025Q4 2025
EPS Actual ($)-0.30 -0.36 0.10*
EPS Consensus Mean ($)-0.37*-0.32*-0.28*
Result vs ConsensusBeatMiss (slightly)Beat

Estimates marked with * retrieved from S&P Global.

Operating Expenses (Quarterly)

Metric ($USD Millions)Q2 2025Q3 2025
R&D Expense3.00 2.19
G&A Expense1.86 1.51
Net Loss3.43 4.16
EPS ($)-0.30 -0.36

Fiscal Year Figures

Metric ($USD Millions, except per-share)FY 2024FY 2025
R&D Expense4.68 9.51
G&A Expense6.68 7.17
Net Loss12.85 9.57
EPS ($)-1.35 -0.79
Cash & Equivalents (year-end)23.01 22.13

Liquidity Progression

Cash & Equivalents ($USD Millions)Sep 30, 2024Dec 31, 2024Mar 31, 2025
Balance15.16 11.06 22.13

Notes:

  • Q4 EPS actual is not disclosed in the 8-K; the value shown comes from S&P Global consensus/actuals and is marked with an asterisk. Estimates marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrior GuidanceCurrent GuidanceChange
NDA Submission (GTx-104)H1 CY2025“Anticipated in 1H CY2025” Filed June 25, 2025 Achieved (submitted)
FDA NDA Filing Review ClockUpon submissionN/A“FDA typically has a 60-day period to determine if the NDA is acceptable for filing” New disclosure
Cash RunwayOpex runwayInto Q2 CY2026 Into Q3 CY2026; to Q2 CY2027 if 2023/2025 warrants exercised Extended
Warrant Proceeds TriggersFinancingUp to $30M potential gross proceeds ($15M upfront + $15M potential via 2025 warrants) Up to $7.6M from 2023 warrants upon FDA acceptance; 2025 warrants exercisable upon approval Added detail/catalysts
GTx-102 PathDevelopmentEoP1 feedback with single pivotal study guidance Same reiterated Maintained

Earnings Call Themes & Trends

Note: No Q4 2025 earnings call transcript was available in our corpus; themes reflect company press releases.

TopicQ2 2025 MentionsQ3 2025 MentionsQ4 2025 (Current)Trend
Regulatory/NDA (GTx-104)Enrollment complete; NDA planned 1H CY2025 STRIVE-ON positive topline; NDA by end of June 2025 FDA alignment achieved; NDA filed; 60-day acceptance window Strengthening; execution milestones hit
Clinical data (STRIVE-ON)Data readout expected Q1 CY2025 Primary endpoint met; evidence of clinical benefit vs oral nimodipine Data underpins NDA; maintained safety profile; pharmacoeconomic signals From anticipated to delivered/central to thesis
Capital/RunwayRunway into Q2 CY2026 $15M upfront; up to $30M potential gross via warrants Runway into Q3 CY2026; potential to Q2 CY2027; additional $7.6M acceptance-trigger warrants Improved runway; incremental catalysts
Corporate actionsRedomicile/name change to GRCE ——Completed; neutral thereafter
Pipeline beyond GTx-104GTx-102 path outlined (single pivotal with confirmatory evidence) Maintained Reiterated Early-stage option value

Management Commentary

  • “Our recent interactions with the FDA have been positive and productive, and we are pleased to achieve alignment with the agency on the substance and structure of our NDA submission.” — Prashant Kohli, CEO .
  • “The submission of our NDA for GTx-104 for the treatment of aSAH is a significant milestone… supported by positive results from our STRIVE-ON trial… provide support for improved clinical outcomes… and pharmacoeconomic evidence of potential benefit.” — Prashant Kohli, CEO .
  • “Data from our STRIVE-ON trial exceeded our expectations… provide support for improved clinical outcomes… and pharmacoeconomic evidence… which could help drive adoption.” — Prashant Kohli, CEO (FY25 results press release) .

Q&A Highlights

  • No Q4 2025 earnings call transcript was found in our corpus; management provided key clarifications in press releases:
    • FDA filing mechanics: 60-day window for acceptance determination following NDA submission .
    • Financing mechanics: up to $7.6M of 2023 warrants may be exercised upon FDA acceptance; separate 2025 warrants are exercisable upon approval, potentially extending runway to Q2 CY2027 .
    • Safety context: no new safety issues identified in STRIVE-ON; AEs comparable between arms; mortality imbalance attributed to disease severity; deaths not drug-related .

Estimates Context

  • Q4 2025 EPS beat: Actual ~$0.10 vs consensus -$0.28; FY 2025 EPS beat: -$0.79 vs -$1.15 consensus, with drivers including favorable non-operating items (change in fair value of warrant liabilities, tax benefit) offsetting higher R&D .
  • Earlier quarters: Q2 2025 slightly beat (-$0.30 vs -$0.37), Q3 2025 slight miss (-$0.36 vs -$0.32) .
  • Revenue consensus is $0 given pre-commercial status; no product revenue disclosed in releases .

Estimates marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst: FDA’s ~60-day acceptance decision for the GTx-104 NDA; acceptance could also unlock ~$7.6M of 2023 warrants, adding to liquidity and potentially de-risking the balance sheet .
  • Regulatory execution has been strong (FDA alignment achieved; NDA submitted on timeline), sharpening focus on review designation and the path to potential approval in a market with limited innovation over ~40 years .
  • Runway extended into Q3 CY2026 (and possibly Q2 CY2027) with multiple financing levers (acceptance/approval-triggered warrants), reducing near-term financing risk during the FDA review cycle .
  • STRIVE-ON data underpin the filing with safety primary endpoint met and signals of clinical and pharmacoeconomic benefit vs oral nimodipine; diligence will track how FDA weighs open-label design and mortality imbalance (not drug-related) .
  • Pre-revenue profile persists; P&L volatility around non-operating items and tax benefits can impact quarterly EPS; investment case is binary around GTx-104 regulatory outcome, with GTx-102 offering secondary optionality .
  • Trading setup: headline sensitivity to NDA acceptance, review designation, and any FDA communications; potential warrant exercises around acceptance/approval could influence float and near-term trading dynamics .

Estimates marked with * retrieved from S&P Global.