Executive Summary

Q2 2026 delivered a narrower net loss of $0.9M and EPS of $0.06, driven by lower R&D post-STRIVE-ON completion; management highlighted FDA acceptance of the GTx-104 NDA with an April 23, 2026 PDUFA target date .
EPS materially beat Wall Street consensus (actual -$0.06 vs consensus -$0.20), while revenue remains pre-commercial at $0; estimates coverage is thin (3 EPS and 3 revenue estimates) [Values retrieved from S&P Global].
Cash was $16.9M at 9/30 with ~$20.0M as of 10/31 aided by ~$4.0M warrant exercises; company cited at least 12-month runway with potential extension into Q2 2027 if all Feb-2025 warrants are exercised .
Near-term stock catalyst: FDA review milestones into the April 23, 2026 PDUFA date, IP expansion (new IV dosing patent), and continued pre-commercial planning for GTx-104 .

What Went Well and What Went Wrong

What Went Well

FDA accepted the NDA for GTx-104; PDUFA target date set for April 23, 2026, advancing the regulatory path and de-risking timelines .
R&D spend fell to $0.6M given completion of STRIVE-ON, helping drive the YOY net loss improvement; G&A was controlled near $2.0M despite pre-commercial activity .
Management quote: “Acceptance of our NDA for review is another significant milestone… we believe [our patent estate] will help to maximize the long-term market value of GTx-104” — CEO Prashant Kohli .

What Went Wrong

No commercial revenue yet; ongoing pre-revenue status keeps reliance on external funding and warrants to bolster liquidity .
Cash declined to $16.9M as of 9/30, reflecting operating burn prior to the late-October warrant inflows; runway is adequate but contingent on future capital options .
Limited consensus coverage (only 3 EPS and 3 revenue estimates) constrains estimate visibility and could amplify stock volatility around regulatory headlines [Values retrieved from S&P Global].

Financial Results

Metric	Q4 2025	Q1 2026	Q2 2026
Revenues ($USD)	$0.00*	$0.00*	$0.00*
Net Income ($USD)	$0.636M*	-$3.362M*	-$0.938M*
Diluted EPS ($USD)	$0.0460*	-$0.2111*	-$0.0589*
EBITDA ($USD)	-$3.179M*	-$3.088M*	-$2.529M*
Total Operating Expenses ($USD)	$3.181M*	$3.090M*	$2.529M*
Cash and Equivalents (end of period) ($USD)	$22.133M*	$20.005M*	$16.862M*

Notes: All values marked with * are Values retrieved from S&P Global.

Selected expense detail (company-reported):

Metric	Q2 2025	Q1 2026	Q2 2026
R&D Expense ($USD Millions)	$3.0	$0.9	$0.6
G&A Expense ($USD Millions)	$1.9	$2.1	$2.0

Other cash references:

Cash and equivalents ~$20.0M as of 10/31/25, aided by ~$4.0M warrant exercises .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Next 12+ months	Not previously quantified for Q2	Runway at least 12 months; could extend into Q2 2027 if Feb-2025 warrants fully exercised	Raised clarity contingent on warrant exercises
Regulatory timeline (GTx-104)	FDA Review	NDA submitted in Q1 2026	NDA accepted; PDUFA date April 23, 2026	Firmed timeline
Revenue / Margins	FY/Qtr	None	No revenue; no margin guidance	Maintained (pre-commercial)
OpEx trajectory	FY/Qtr	Higher R&D pre-Phase 3 completion	Lower R&D post-STRIVE-ON; G&A near $2.0M amid pre-commercial planning	Lower R&D, stable G&A

Earnings Call Themes & Trends

Note: No full earnings call transcript was located; analysis of themes relies on press releases and SEC-linked documents .

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q2 2026)	Trend
Regulatory/legal	Q1: NDA submitted; awaiting acceptance	NDA accepted; PDUFA 4/23/26	Positive progression toward approval
R&D execution	Q1: STRIVE-ON completion highlighted; R&D down	R&D down to $0.6M; leveraging STRIVE-ON data	Transition from development to pre-commercial
IP protection	Prior: strong patent estate cited	New IV dosing patent granted; protection to 2043	Strengthening moat
Financing/liquidity	Prior: ~$20M cash at 6/30/25	~$4.0M warrants exercised; ~$20M cash by 10/31/25	Liquidity improved post acceptance
Pre-commercial planning	Q1: noted commercial assessment work	G&A increase partly due to pre-commercial planning	Building launch readiness

Management Commentary

“Acceptance of our NDA for review is another significant milestone… We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders.” — CEO Prashant Kohli .
Emphasis on STRIVE-ON outcomes: reduced clinically significant hypotension and improved functional outcomes versus oral nimodipine, presented at the Neurocritical Care annual meeting .
IP expansion: new method-of-use patent for IV dosing regimen expected to be included in label if approved, extending protection to 2043 .

Q&A Highlights

A full Q2 2026 earnings call transcript was not located; no Q&A themes could be verified from primary transcripts .
Management’s clarifications around cash runway and warrant exercises are documented in press releases rather than call Q&A .

Estimates Context

Metric	Q2 2026 Consensus	Actual
Primary EPS Consensus Mean ($)	-0.2008*	-0.0604*
Revenue Consensus Mean ($)	0.00*	0.00*
Net Income Normalized Consensus Mean ($)	-3.9537M*	-0.9380M*
EBITDA Consensus Mean ($)	-3.9508M*	-2.5290M*
Primary EPS – # of Estimates	3*	—
Revenue – # of Estimates	3*	—

Notes: All values marked with * are Values retrieved from S&P Global. Result: EPS beat vs consensus; revenue in line at $0.

Key Takeaways for Investors

EPS beat reflects disciplined OpEx, particularly lower R&D post-STRIVE-ON, while pre-revenue status persists; trend is favorable for quarterly loss reduction as launch prep continues .
Liquidity strengthened post-NDA acceptance via ~$4.0M warrant exercises; runway ≥12 months with optionality to extend through Q2 2027 if all Feb-2025 warrants are exercised .
Regulatory momentum (NDA accepted; April 23, 2026 PDUFA) and expanded IP (IV dosing patent to 2043) increase probability-adjusted value of GTx-104; a key medium-term thesis driver .
Near-term trading dynamics likely hinge on FDA review updates and any additional financing signals; limited sell-side coverage may amplify moves on news [Values retrieved from S&P Global].
Focus diligence on launch readiness: hospital access, label inclusion of dosing regimen, and HCP education to translate STRIVE-ON outcomes into early adoption if approved .
Monitor OpEx mix: continued R&D moderation vs incremental commercial build-out; G&A tracked at ~$2.0M in Q2 with pre-commercial planning .
Key catalyst calendar: PDUFA 4/23/26; potential investor events and IP updates that reinforce launch positioning .

Additional references:

Company press release hub (Q2 and related updates): .
Q2 2026 press release PDF: .
Q1 2026 press release: .
Indicator of Q2 2026 8-K presence (news mirror): .

Notes: Where full call transcripts were unavailable, analysis relies on company press releases and linked SEC/IR materials. All SPGI-derived figures are marked with * and accompanied by the S&P Global disclaimer.

Grace Therapeutics, Inc. (GRCE)·Q2 2026 Earnings Summary