Executive Summary

GRCE reported Q3 FY2025 (quarter ended Dec 31, 2024) net loss of $4.2M ($0.36/share) as R&D spend stepped up for the pivotal Phase 3 STRIVE-ON safety trial; cash was $11.1M at quarter-end, down from $15.2M in Q2 FY2025 and $23.0M at FY start .
Clinical/regulatory momentum accelerated: STRIVE-ON met its primary endpoint and management reiterated/clarified NDA timing for GTx‑104 in aSAH, targeting submission by end of June 2025 (1H CY25) .
Balance sheet strengthened post-quarter: private placement of $15M upfront (net ~$13.8M) with potential total gross proceeds up to ~$30M via warrants, to fund precommercial build and potential launch if approved .
No product revenue or financial guidance was provided; S&P Global Wall Street consensus estimates were unavailable at request time, so beats/misses versus Street cannot be assessed in this report (will update upon availability) .

What Went Well and What Went Wrong

What Went Well

STRIVE-ON positive topline: management said “Data from our STRIVE-ON trial exceeded our expectations, demonstrating that GTx-104 was associated with improved clinical outcomes…compared to orally administered nimodipine,” supporting clinical and pharmacoeconomic rationale ahead of NDA .
Clearer regulatory timeline: company now “focus[ed] to finalize NDA submission for GTx‑104 by the end of June 2025” (1H CY25), locking timing for the next major catalyst .
Financing and launch preparation: $15M upfront (potential up to ~$30M) private placement led by specialist funds to support precommercial planning, team build, and launch readiness if approved .

What Went Wrong

Operating loss widened YoY on higher trial activity: net loss was $4.2M vs $2.4M YoY, driven by +$0.8M R&D and derivative warrant liability fair value change, partially offset by tax benefit; G&A decreased slightly YoY .
Cash burn continued: quarter-end cash fell to $11.1M from $15.2M in Q2 and $23.0M at March 31, 2024, reflecting investment in Phase 3 and operations (note: subsequent financing bolsters liquidity) .
No revenue contribution or margin structure yet (pre-revenue biotech), keeping the story reliant on regulatory milestones and adoption outlook rather than financial beats/misses .

Financial Results

Metric	Q3 FY2024 (Dec 31, 2023)	Q2 FY2025 (Sep 30, 2024)	Q3 FY2025 (Dec 31, 2024)
Net Loss ($MM)	$(2.39)	$(3.43)	$(4.16)
Diluted EPS ($)	$(0.21)	$(0.30)	$(0.36)
R&D Expense ($MM)	$(1.44)	$(2.98)	$(2.19)
G&A Expense ($MM)	$(1.60)	$(1.86)	$(1.51)
Change in FV of Derivative Warrant Liabilities ($MM)	$0.13	$0.36	$(1.18)
Interest & Other Income, net ($MM)	$0.32	$0.17	$0.14
Income Tax Benefit ($MM)	$0.21	$0.85	$0.61
Cash & Cash Equivalents ($MM, period-end)	N/A	$15.16	$11.06

Notes: GRCE reported no product revenue; operating statement presented as expenses and losses (typical for development-stage biotech) . Post-quarter financing provided $15.0M gross upfront with ~$13.8M net proceeds and up to ~$30.0M potential gross including warrants .

Segment breakdown and gross margin not applicable (no commercial revenue) .

KPIs:

Cash runway (prior disclosure): projected into second calendar quarter of 2026 (pre-financing update; management did not reiterate in Q3 release) .
Financing: $15M upfront, up to ~$30M potential total gross proceeds to fund precommercialization and launch readiness if approved .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
GTx-104 STRIVE-ON status	Q3 FY2025	Enrollment complete; data readout expected Q1 CY2025	Trial met primary endpoint; clinical benefit vs oral nimodipine reported	Upgraded (milestone achieved)
GTx-104 NDA timing	CY2025	NDA submission in 1H CY2025	Targeting NDA submission by end of June 2025	Clarified/tightened timing
Financing/Liquidity	N/A	Cash runway projected into 2Q CY2026	$15M upfront private placement (net ~$13.8M), up to ~$30M potential including warrants	Increased liquidity resources
GTx-102 regulatory path	N/A	Program deprioritized to focus on GTx‑104	FDA EOP1 written feedback outlines single pivotal trial path to support NDA with confirmatory evidence	Path clarified (no timing guidance)

Earnings Call Themes & Trends

(Company did not publish an earnings call transcript for Q3 FY2025 in the document catalog; themes draw from Q2 release, Q3 release, and the Nov 20, 2024 KOL event transcript.)

Topic	Previous Mentions (Q2 FY2025)	Current Period (Q3 FY2025)	Trend
Regulatory timeline (GTx-104)	STRIVE-ON enrollment complete; readout Q1 CY2025; NDA in 1H CY2025	STRIVE-ON met primary endpoint; NDA by end of June 2025	Positive momentum; timing clarified
Clinical benefit vs oral nimodipine	Emphasis on unmet need; completion of enrollment	Company states improved clinical outcomes vs oral nimodipine in STRIVE-ON topline	Strengthened efficacy narrative
Financing/pre-commercial planning	Cash runway into 2Q CY2026	$15M upfront financing (potential up to ~$30M) to fund precommercial build	Liquidity enhanced; go-to-market preparation
Hospital adoption dynamics	—	KOLs highlight operational/tolerability issues with oral nimodipine; IV nimodipine seen as clinically and operationally advantageous; likely formulary additions with initial restrictions	Building third-party clinical support
Market opportunity	$300M US addressable market (prior disclosure)	Not reiterated in Q3 PR	Unchanged externally
Pipeline beyond GTx-104	GTx‑102 deprioritized	FDA EOP1 feedback outlines potential pivotal path for GTx‑102	Optionality improved (timing TBD)

Management Commentary

“Data from our STRIVE-ON trial exceeded our expectations…provides both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in aSAH patients” — Prashant Kohli, CEO .
“We secured up to $30 million…This investment will support pre-commercial planning, commercial team build out and product launch if GTx‑104 is approved…Our focus now is to finalize NDA submission…by the end of June 2025” — Prashant Kohli, CEO .
Highlights reiterated: STRIVE‑ON met primary endpoint; NDA anticipated 1H CY2025; $15M upfront financing with potential up to ~$30M; KOL event underscored unmet need .

Q&A Highlights

(From the Nov 20, 2024 KOL event transcript)

IV nimodipine clinical rationale: Oral nimodipine’s hypotension, PK variability, administration challenges (NG/OG tubes, intolerance) limit full 21‑day exposure; IV offers guaranteed exposure, titratability, and operational flexibility in the ICU .
Adoption pathway: Expect formulary addition with initial restriction criteria (e.g., patients intolerant of oral or lacking enteral access), with criteria potentially loosening as clinical experience accrues and cost-benefit is established .
Physician perspective: “Majority of centers will want [IV nimodipine] in their formulary” due to titratability and ICU fit; analogous to other titratable IV neurocritical meds .
Hypotension management: IV infusion may mitigate peak hypotensive drops seen with oral dosing; better alignment with vasopressor management during vasospasm .

Estimates Context

Wall Street consensus (S&P Global) for Q3 FY2025 EPS and revenue was unavailable at request time; therefore, we cannot quantify beats/misses versus Street in this report. We will update this section when S&P Global consensus becomes available.

Key Takeaways for Investors

Regulatory inflection: With STRIVE‑ON positive and NDA targeted by end of June 2025, regulatory milestones are the dominant near-term stock catalysts .
Commercial readiness: Fresh $15M upfront financing (potential up to ~$30M) earmarked for precommercial build increases launch preparedness if GTx‑104 is approved .
Hospital adoption setup: KOLs describe strong clinical/operational rationale for IV nimodipine in aSAH; expect formulary adoption with initial restrictions that may ease over time as experience accumulates .
Financial trajectory: Net loss widened sequentially and YoY on planned trial spend; cash fell to $11.1M at Q3-end before the subsequent financing, which should extend runway vs quarter-end levels .
Pipeline optionality: FDA EOP1 feedback for GTx‑102 outlines a potential pivotal path (with confirmatory evidence), adding medium-term optionality beyond GTx‑104 .
Trading lens: Near-term stock moves likely tied to NDA submission/acceptance and any additional clinical, regulatory, or partnership updates; absence of revenue means narrative remains binary/regulatory-driven in the short run .

Appendix: Additional Detail

Third Fiscal Quarter 2025 drivers: Net loss increased primarily due to derivative warrant liability fair value change (+$1.3M YoY impact), higher R&D (+$0.8M), and lower interest income (−$0.2M), partially offset by higher tax benefit (+$0.4M) .
Operating expense mix: R&D $2.2M (up from $1.4M YoY) driven by STRIVE‑ON Phase 3 activities; G&A $1.5M (down from $1.6M YoY) on lower professional fees and stock comp, partly offset by higher salaries/benefits .
Balance sheet: Cash & equivalents $11.1M at Dec 31, 2024; total assets $61.2M; stockholders’ equity $52.1M .

Sources: Q3 FY2025 8-K/press release and exhibits; Q2 FY2025 8-K/press release; Nov 20, 2024 KOL event transcript -.

Grace Therapeutics, Inc. (GRCE)·Q3 2025 Earnings Summary