Grace Therapeutics, Inc.
GRCE evidence brief
What we can confirm
- BioSniper Score:
- 7.3 / 10
- Market Cap:
- $44.6M
- Cash Runway:
- 12.8 mo
What it means
What to watch
Prepared research question
What matters most for GRCE—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · GRCE
Grace Therapeutics (GRCE) is a late-stage biopharmaceutical company developing novel drug delivery technologies for rare and orphan diseases, with a lead injectable nimodipine candidate (GTx-104) for acute subarachnoid hemorrhage (aSAH) that has received a Complete Response Letter from the FDA.
Key risk: GTx-104 CRL delays
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 1 clinical trial for Grace Therapeutics, Inc..
Grace Therapeutics (GRCE) is a late-stage biopharmaceutical company developing novel drug delivery technologies for rare and orphan diseases, with a lead injectable nimodipine candidate (GTx-104) for acute subarachnoid hemorrhage (aSAH) that has received a Complete Response Letter from the FDA.
- Lead candidate GTx-104 is a novel injectable formulation of nimodipine for IV infusion in aSAH patients [news · 2026-08-13].
- Received a Complete Response Letter from the FDA citing manufacturing deficiencies and non-clinical issues for GTx-104 [sec_mda · as of 2026-06-18].
- Cash & equivalents were $13.8M as of 2026-06-30, with a net loss of $15.8M for the period [sec].
- Completed a private placement in August 2026 raising approximately $9.1M net proceeds [sec_mda · as of 2026-08-13].
- Pipeline includes GTx-101 (for postherpetic neuralgia) and GTx-102, with worldwide commercialization rights [sec · filed 2026-08-24].
What works
- Focus on rare/orphan diseases may allow smaller, more manageable clinical trials and targeted commercial infrastructure [sec · filed 2026-08-24].
- Management team has significant experience in drug formulation, delivery, clinical development, and regulatory affairs [sec · filed 2026-08-24].
- Company holds worldwide commercialization rights for all pipeline candidates, providing strategic flexibility [sec_mda · as of 2026-08-13].
- Novel drug delivery technologies aim to improve efficacy, onset, side effects, and patient compliance [sec · filed 2026-08-24].
What to weigh
- Heavily dependent on the success of lead candidate GTx-104, which received a Complete Response Letter from the FDA [sec_mda · as of 2026-06-18].
- No history of commercializing drugs, making future viability assessment difficult [sec_mda · as of 2026-06-18].
- Continued operating losses and negative cash flows since inception; cash & equivalents declined from $22.1M (March 2025) to $13.8M (June 2026) [sec_mda · as of 2026-06-18] [sec].
- Additional funding may be required to maintain operations and advance R&D/commercialization [sec_mda · as of 2026-06-18].
From the filings
Quoted directly from source documents.
GTx-104 received a Complete Response Letter from the FDA
“We received a Complete Response Letter from the FDA citing certain manufacturing deficiencies and other non-clinical issues, which may delay or prevent approval of GTx-104.”
SEC MD&A · June 18, 2026
Company has worldwide commercialization rights for all pipeline candidates
“We have worldwide commercialization rights for all our pipeline drug candidates and plan to maximize the value of each of our drug candidates over time.”
SEC MD&A · August 13, 2026
Private placement in August 2026 raised approximately $9.1M net proceeds
“The net proceeds to us from the 2026 Private Placement were approximately $9,100, after”
SEC MD&A · August 13, 2026
Risks & what to watch (4)›
Key risks
- GTx-104 CRL delays — FDA CRL for GTx-104 cites manufacturing and non-clinical issues that may delay or prevent approval [sec_mda · as of 2026-06-18].
- Cash runway uncertainty — Cash declined from $22.1M (Mar 2025) to $13.8M (Jun 2026); continued losses may require additional funding [sec_mda · as of 2026-06-18] [sec].
- No commercial history — Company has never commercialized a drug, making future revenue generation unproven [sec_mda · as of 2026-06-18].
- Single-product dependency — Heavily dependent on GTx-104; failure would severely impact the company [sec_mda · as of 2026-06-18].
What to watch
- Resubmission of the NDA for GTx-104 and FDA acceptance/approval timeline [sec · filed 2026-08-24].
- Progress on addressing CRL items, including technology transfer or contract manufacturer remediation [sec_mda · as of 2026-08-13].
- Cash burn rate and potential need for additional financing beyond the August 2026 private placement [sec_mda · as of 2026-06-18].
- Development updates for GTx-101 (PHN) and GTx-102, including potential out-licensing or partnership decisions [sec_mda · as of 2026-08-13].
Sources: News · SEC filings · SEC MD&A · Generated October 7, 2026 · How we verify sources →
Run Grace Therapeutics, Inc. through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available Grace Therapeutics, Inc. facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
12.8 months
D/E 0.04 · 0% dilution
Lead: BLA Filed
1 candidate
No upcoming catalysts tracked
4 buys · 0 sells (180d)
Runway
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
34
Total value held
$19.7M
| Holder | Shares | Value |
|---|---|---|
| cerity partners llc | 849,055 | $3.9M |
| eversept partners, lp | 756,600 | $3.5M |
| nantahala capital management, llc | 728,203 | $3.4M |
| bank of america corp /de/ | 494,723 | $2.3M |
| vanguard capital management llc | 401,656 | $1.9M |
| renaissance technologies llc | 243,910 | $1.1M |
| jane street group, llc | 167,097 | $774K |
| citadel advisors llc | 98,742 | $457K |
| marshall wace, llp | 91,416 | $423K |
| connective capital management, llc | 84,549 | $391K |
Showing top 10 of 34 institutional holders of Grace Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 21, 2026- % of float
- 16.7%
- Days to cover
- 1.6
- Shares short
- 2,199,232
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
GRCE short interestGovernance
Frequently asked questions
What is the AI investment thesis for Grace Therapeutics, Inc.?
Grace Therapeutics (GRCE) is a late-stage biopharmaceutical company developing novel drug delivery technologies for rare and orphan diseases, with a lead injectable nimodipine candidate (GTx-104) for acute subarachnoid hemorrhage (aSAH) that has received a Complete Response Letter from the FDA.
What is Grace Therapeutics, Inc.'s lead drug candidate?
Grace Therapeutics, Inc.'s most advanced tracked candidate is gtx-104 (BLA Filed) for aneurysmal subarachnoid hemorrhage (aSAH).
Who is the CEO of Grace Therapeutics, Inc.?
Mr. Prashant Kohli is the chief executive officer of Grace Therapeutics, Inc. (GRCE).
Where is Grace Therapeutics, Inc. headquartered?
Grace Therapeutics, Inc. (GRCE) is headquartered in Princeton, NJ, United States.
What therapeutic areas does Grace Therapeutics, Inc. focus on?
Grace Therapeutics, Inc. develops therapies across Rare Disease, Metabolic.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.