Grace Therapeutics, Inc. (GRCE)
Grace Therapeutics (Nasdaq: GRCE) rebranded from Acasti Pharma and refocused on rare disease drug reformulations using the 505(b)(2) pathway. Its lead candidate, GTx-104 (injectable nimodipine for aSAH), delivered positive Phase 3 STRIVE-ON results, reducing hypotension events, improving dose int...
Grace Therapeutics (Formerly Acasti Pharma) 10-K Review
This blog post dives deep into the most important elements of Grace TherapeuticsInc.'s (Nasdaq: GRCE) 10-K for fiscal year ended March 31, 2025. We cover:
Warren.AI 💰 6.5 / 10
- Company overview & strategic pivot from Acasti to Grace
- Late-stage pipeline highlights, with a deep focus on GTx-104
- Market opportunities in rare and orphan diseases
- Key clinical data: STRIVE-ON Phase 3 trial
- FDA regulatory pathway and upcoming NDA
- Early-stage programs: GTx-102 and GTx-101
- Financial performance, cash runway, and capital raises
- Principal risk factors
- Investment outlook and score
1. Company Overview & Strategic Pivot
Formerly Acasti Pharma Inc., the company re-domesticated to Delaware and rebranded as Grace Therapeutics on October 28, 2024. This strategic move aligns their U.S. operations with a new leadership team and a sharpened focus on late-stage drug development in rare and orphan indications.
Mission
Grace aims to repurpose well-understood, FDA-approved drugs using novel drug delivery technologies—improving efficacy, safety and patient convenience while leveraging the 505(b)(2) pathway for a more efficient regulatory path.
Management & Headquarters
- CEO: Prashant Kohli (joined November 2023)
- Headquarters: Princeton, NJ
- Employees: 6 full-time as of March 31, 2025
They have a lean, specialized R&D and commercialization strategy, supported by contract research organizations (CROs) and contract manufacturing organizations (CMOs).
2. Pipeline Snapshot
Gracehas three clinical-stage candidates—all granted FDA orphan designation:
| Candidate | Indication | Status |
|---|---|---|
| GTx-104 | IV nimodipine for aneurysmal subarachnoid hemorrhage (aSAH) | Completed Pivotal Phase 3 STRIVE-ON Trial; NDA planned |
| GTx-102 | Oral betamethasone spray for Ataxia-Telangiectasia (A-T) | Phase 1 PK bridging data reported; next steps require funding or partnership |
| GTx-101 | Topical bupivacaine film for Postherpetic Neuralgia (PHN) | Phase 1 trials completed; deprioritized pending partnership |
Why Grace Focused on Rare & Orphan Diseases
- Orphan Drug Act incentives: 7 years marketing exclusivity, tax credits and fee waivers
- Smaller, manageably sized trials
- Unmet medical needs in aSAH, A-T and PHN with no or inadequate standard therapies
3. GTx-104: Leading Candidate
Disease Background
Aneurysmal subarachnoid hemorrhage (aSAH) is a type of stroke caused by aneurysm rupture, leading to bleeding around the brain. ~42,500 U.S. cases/year, high mortality (~25%) and morbidity (~40%).
Current Standard & Unmet Needs
Oral nimodipine (generic capsules, branded liquid) is the only therapy proven to improve outcomes. However:
- Poor water solubility → variable blood levels and absorption
- High first-pass metabolism → low bioavailability (~7%)
- Dose-limiting hypotension → frequent interruptions
- Dysphagic/unconscious patients rely on nasogastric administration or messy liquid solutions
Grace’s Technology Platform
GTx-104 is an injectable nanoparticle formulation of nimodipine for IV infusion.
- 100% bioavailability vs ~7% oral
- Lower PK variability → better BP control
- Easy prep in pharmacy, stable at room temp
- Avoids feeding tube in ICU
Phase 3 STRIVE-ON Trial
Design: Open-label, randomized, 50 pts on GTx-104 vs 52 on oral nimodipine over 21 days, with 90-day follow-up.
Topline Results (Feb 10, 2025):
- 19% relative reduction in clinically significant hypotension events (28% vs 35%)
- 54% of GTx-104 arm achieved ≥95% dose intensity vs 8% oral
- 29% relative increase in favorable 90-day mRS outcomes
- Gains in ICU readmissions, ICU days and ventilator days
- No new safety signals; deaths driven by disease severity
Pivotal PK Bridging Study:
- Single-dose trial in ~50 healthy volunteers
- GTx-104 matched oral nimodipine exposures (Cₘₐₓ/AUC) with significantly less inter/intra-subject variability
- No serious adverse events
Regulatory Path:
- FDA Type C written response received April 2025: data & CMC packages are sufficient for NDA submission
- NDA targeted for Q2 2025, orphan exclusivity expected
Market Opportunity:
- U.S. cases: 42,500–70,000/year, EU: ~60,000, China: ~150,000
- Key Opinion Leader survey: 80% of hospitals likely to adopt IV nimodipine
4. Early-Stage Programs
GTx-102: Betamethasone Oral Spray for A-T
- Phase 1 PK bridging vs unapproved liquid and approved injectable betamethasone:
- GTx-102 achieves similar blood levels at 1/70th the volume
- Well-tolerated in healthy volunteers
- A-T trial data (Zannolli et al. in Italy): 13 pediatric A-T pts, double-blind, crossover vs placebo
- 28–31% median reduction in ICARS ataxia score
- Minimal side effects
- Next Steps: FDA End-of-Phase-1 response (Feb 13, 2025) supports single pivotal Phase 3 design with neurological scale endpoints
- Funding is needed for pivotal trial; potential out-license or sale
GTx-101: Bupivacaine Film for PHN
- Four Phase 1 SAD/MAD trials in healthy volunteers
- Well-tolerated, no skin irritation
- Low systemic absorption, high local bioavailability
- Marketed second-line: oral gabapentin, lidocaine patches; each has limitations (ineffective, ugly, dosing constraints)
- Market Opportunity: ~120,000 U.S. PHN cases/year; $200 million PHN market + $2.3 billion non-PHN
- Deprioritized in favor of GTx-104 pending partnerships or funding
5. Financial Highlights (Year ended March 31)
|
---|---|---|---| | 2025 | 2024 | Change | | Cash & Cash Equivalents | $22.1 M | $23.0 M | –$0.9 M | | Net Loss | –$9.6 M | –$12.9 M | +$3.3 M | | R&D Expense (net) | $9.5 M | $4.7 M | +$4.8 M | | G&A Expense | $7.2 M | $6.7 M | +$0.5 M | | Derivative Warrant Fair-Value Gain/(Loss) | +$3.2 M | –$2.7 M | +$5.9 M |
- Net loss narrowed to $9.6 M (–$0.79/sh) vs $12.9 M (–$1.35/sh) in 2024
- R&D ramped up $4.8 M for pivotal Phase 3
- G&A rose modestly on professional fees (Continuance, Domestication)
- GTx-104 fundraising: $13.7 M in Feb 2025 PP; runway > 12 months as of March 31, 2025
6. Principal Risks
- Clinical & Regulatory Path: GTx-104 relies on “fast-track” 505(b)(2). Delays/hold could drag timelines & raise costs.
- Funding: Ongoing losses, cash runway to Q3 2026, need > $20 M for NDA/commercial launch.
- Competition: Generic oral nimodipine, future generics, other aSAH therapies in development.
- Manufacturing: Reliance on CMOs may cause supply/disruption risks.
- Intellectual Property: 505(b)(2) overlap with reference drug patents & potential infringement claims.
- Go-to-Market: High-value, hospital-based complex sales vs established generics.
Despite these risks, orphan designation, positive Phase 3 safety data and a large unmet need underpin GraceTherapeutics' upside.
7. Investment Outlook & Score: 6.5/10
|
Factor |
Impact | |---|---| | Clinical Success | Positive Phase 3, but full NDA data must convince FDA | | Market | ~$100 M U.S. aSAH market, license potential outside U.S. | | Financing | Q2 2025 NDA filing uses cash; $13.7 M raised, but further funding needed | | Competitive Landscape | Generics entrenched but IV nimodipine is a new segment | | IP & Exclusivity | 7 years orphan exclusivity; composition/method patents pending | | Risk | Execution, regulatory hold, commercial scaling, future dilution |
Score 6.5/10—Grace Therapeutics shows compelling Phase 3 data for GTx-104 and a clear path to NDA, but it remains an early-stage biotech with no revenue. Additional capital raises, FDA approval and successful commercialization execution will be key drivers for upside.
Read our full 10-K review for more details on the companys financials, pipeline, and risks ➡️ [BLOGPOSTURL]