Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Investor Presentation (April 2026)
32 slides from Grace Therapeutics's investor presentation, Apr 27, 2026
Slide 1: Corporate Presentation April 2026
Corporate Presentation April 2026
Slide 2: Forward Looking Statements
Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, a
Slide 3: Executive Summary
Summary GTx-104 – novel intravenous nimodipine – well positioned to solve oral challenges and potentially displace oral as SoC Nimodipine is the SoC and clinically de-risked; however, significant unmet needs remain with its only available oral form Pivotal Phase 3 STRIVE-ON safety trial met primary
Slide 4: FDA Complete Response Letter (CRL) – Key Findings & Path Forward
4 FDA Complete Response Letter (CRL) – Key Findings & Path Forward CRL driven by CMC data package completeness and manufacturing readiness No clinical deficiencies identified Clear path to resolution expected following FDA alignment at Type A meeting FDA Feedback Company Assessment Path Forward Leac
Slide 5: aSAH is a Rare and Severe Acute Brain Injury
aSAH is a Rare and Severe Acute Brain Injury Subarachnoid Hemorrhage aSAH results in bleeding over the surface of the brain in the space between the brain and skull Primary cause is rupture of an aneurysm Condition can occur quickly, immediate intervention is key to survival Patients require surgica
Slide 6: Oral Nimodipine – The aSAH Standard of Care for >3 Decades
Oral Nimodipine – The aSAH Standard of Care for >3 Decades 6 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). DCI: Delayed Cerebral Infarction The Joint Commision is a hospital accredation agency 2023 AHA/ASA GuidelinesFor the management of patients with aSAH Nimodipine is the only approv
Slide 7: Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes
Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes 7 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). aOR: adjusted odds ratio; CI: Confidence Interval Nimodipine cessation or dose reduction independently associated with poor functional outcomes (aOR 0.89, 95% CI
Slide 8: Substantial Shortcomings of Oral Nimodipine
8 Substantial Shortcomings of Oral Nimodipine Sources: Nimodipine Prescribing Label, Sandow et al., Mahmoud et al., Abboud et al., Soppi et al., Rabaut et al., Ho et al., Fletcher Spaght market research. Administration Challenges High dosing burden of 60mg (2 x 30mg capsules), 6 times per day 45% of
Slide 9: GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges
GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges Supported by Strong IP, Ph. III Trial Success 9 CMC: Critical micelle concentration. Orphan Drug Status with seven-year market exclusivity and additional multi-layered IP protection Drug loaded micelles Nimodipine 10– 15
Slide 10: GTx-104 Value Proposition
GTx-104 Value Proposition 10 Risk of Fatal Parenteral Use Requires Feeding Tube Excipient Intolerance Hemodynamic Control Dose Compliance Markets Nimodipine Capsules Yes Yes No Poor Poor U.S. / WW NYMALIZE (Oral Liquid) Yes (Reduced) Yes Yes Poor Poor U.S. / Select WW NIMOTOP (Injectable) No No Yes
Slide 11: Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral Nimodipine
Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral Nimodipine 11 Source: GTx-104-002 CSR; results announced May 2022 Significantly lower dose variability relative to oral capsule Consistent and predictable plasma concentrations GTx-104 IV infusion vs Oral capsule: AUC Day_3 0-24hr
Slide 12: STRIVE-ON Phase 3 Trial
STRIVE-ON Phase 3 Trial
Slide 13: GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design
GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design 13 mRS: modified Rankin Scale STRIVE-ON (NCT05995405) is a ~100-patient prospective, open-label, randomized (1:1 ratio), parallel group trial of GTx-104 compared with oral nimodipine in patients hospitalized for aSAH Screening Period (within 96 h
Slide 14: STRIVE-ON Trial Data Demonstrates Key Clinical, Pharmacoeconomic, and Dosing Benefits
14 STRIVE-ON Trial Data Demonstrates Key Clinical, Pharmacoeconomic, and Dosing / Administration Benefits over Current SoC, Oral Nimodipine CLINICAL IMPROVED 90-DAY OUTCOMES (MRS*) +29% relative increase in patients with good recovery at 90 days vs. oral nimodipine FEWER HYPOTENSION EVENTS -19% redu
Slide 15: Demographics & Baseline Characteristics
15 Demographics & Baseline Characteristics GTX-104 (N = 50) Oral Nimodipine (N = 52) Age (mean) 55 56 Sex, n (%) Female Male 33 (66.0%) 17 (34.0%) 33 (63.5%) 19 (36.5%) Hunt & Hess Grade, n (%) I II III IV V 10 (20%) 15 (30%) 15 (30%) 6 (12%) 4 (8%) 8 (15%) 15 (29%) 16 (31%) 12 (23%) 1 (2%) Demograp
Slide 16: Primary Endpoint – Clinically Significant Hypotension
16 Primary Endpoint – Clinically Significant Hypotension ~19% relatively fewer patients with clinically significant hypotension in GTx-104 GTX-104 (N = 50) n (%) Oral Nimodipine (N = 52) n (%) Clinically Significant Hypotension 14 (28%) 18 (35%) Clinically significant hypotension: decrease in systol
Slide 17: Relative Dose Intensity (RDI)
17 Relative Dose Intensity (RDI) 54% of patients on GTx-104 had RDI of 95% or higher versus 8% on Oral Nimodipine GTx-104 Oral Nimodipine RDI = (total dose administered / total amount of expected dose) * 100.
Slide 18: Clinical Outcomes – mRS (day 90)
18 Clinical Outcomes – mRS (day 90) ~29% relative increase in patients with good recovery in GTx-104 ~29% * 3 patients did not complete physician-conducted mRS at day-90. However, all 3 were confirmed alive at day-90 ** 6 patients did not complete physician-conducted mRS at day-90. 5 were confirmed
Slide 19: Clinical Outcomes – QoL (Quality of Life; day 90)
19 Clinical Outcomes – QoL (Quality of Life; day 90) Patient-reported health scores favor GTx-104 QoL GTx-104 (N = 381) Oral Nimodipine (N = 402) Your Health Today Score mean (0 = being worst -> 100 = great) 75 70 Mobility, n (%) I have no or some problems I am confined to bed 38 (100%) 0 35 (88%) 5
Slide 20: Safety
20 Safety Overall safety was comparable between the two groups Summary of Adverse Events (AEs) (entire study duration of 90 days) GTx-104 (N = 50) Oral Nimodipine (N = 52) All AEs, n (%) # of events 44 (88%) 157 43 (83%) 193 All AEs, events per n 3.6 4.5 All SAEs1, n (%) # of events 18 (36%) 34 25 (
Slide 21: ICU Length of Stay, Mechanical Ventilator & Readmissions
21 ICU Length of Stay (los), Mechanical Ventilator & Readmissions 1.5 fewer ICU days, 5 fewer ventilator days, and 48% relatively fewer ICU readmissions in GTx-104 GTx-104 (N = 50) Oral Nimodipine (N = 52) ICU los, days Mean (SD) 16.4 (6.7) 17.9 (10.4) Mechanical Ventilation days Mean (SD) 5.6 (5.7)
Slide 22: Pharmacoeconomics
22 Pharmacoeconomics Major patient resource utilization drivers in aSAH favor GTx-104 GTx-104 (N = 50) n* Oral Nimodipine (N = 52) n* Day 1 Day 14 % change Day 1 Day 14 % change Mechanical Ventilation 14 1 -93% 12 7 -42% External Ventricular Drain 32 10 -69% 35 17 -51% Deep Sedation 5 1 -80% 8 5 -38
Slide 23: Commercial Preparation
atest Commercial Preparation OD 3eBlace
Slide 24: aSAH Market Opportunity
~45% of treated patients are unconscious or dysphagic (nasogastric tube) >25% of treated patients have poor dose compliance / blood pressure control aSAH Market Opportunity 24 Literature, typically limited to basal cistern aSAH (~80% of aSAH), suggests ~42.5K U.S. hospital-treated patients Claims an
Slide 25: GTx-104 seen as valuable for tolerability, cost savings, and easy IV use
25 GTx-104 is seen as valuable for its improved tolerability, cost savings, and easy IV use – with broad formulary inclusion by P&T committee EFFICACY PHARMACOECONOMIC ROA (route of admin) “… The pro of Product X is certainly the efficacy endpoint. The fact that there is a reduction in hypotensive e
Slide 26: Concentration of aSAH Care – Efficient Commercialization
Concentration of aSAH Care – Efficient Commercialization 26 aSAH-Treating Institutions Concentration PatientVolume Analysis includes n = 3,227 institutions where at least one aneurysmal SAH patient is treated Concentration of aSAH Patients % of Institutions % of Patients ~80% of aSAH patients spread
Slide 27: Intellectual Property Portfolio
Intellectual Property Portfolio 27 Multi-layered intellectual property protection strategy GTx-104 received orphan drug status designation from the FDA Potential 7 years of marketing exclusivity in US upon NDA approval US and international patent estate Consists primarily of formulation and method-o
Slide 28: Capitalization
Capitalization Grace Therapeutics, Inc. (GRCE) Cap Table (as of December 31, 2025) Cash & Cash Equivalents Balance USD $18.7 M Outstanding Common Stock 15,474,026 Debt NONE Stock options granted and outstanding 1,305,453 Total Fully Diluted Shares Outstanding1 22,993,731 28 1 Includes Pre-Funded War
Slide 29: Experienced Leadership Team
Experienced Leadership Team 29 Carrie D'Andrea VP Clinical Operations Loch Macdonald, MD, PhD Chief Medical Officer Prashant Kohli Chief Executive Officer Amresh Kumar, PhD VP Program Management Robert J. DelAversano Principal Financial Officer and Principal Accounting Officer Alejandro A. Rabinstei
Slide 30: Appendix (Deprioritized Programs)
Appendix (Deprioritized Programs)
Slide 31: GTx-102 Program Overview & Regulatory Update
31 GTx-102 Program Overview & Regulatory Update GTx-102 Novel oral spray formulation of betamethasone intended to improve neurological symptoms of A-T patients Proof of concept supported by well-controlled Phase 1 trial with A-T patients PK bridging study topline results announced on 12/18/22 met al
Slide 32: GTx-101 Program Overview
32 GTx-101 Program Overview GTx-101 Non-narcotic, topical, bio-adhesive, transparent film-forming bupivacaine spray Biphasic drug release expected to provide immediate and continuous relief Potential Addressable market ~$200m (PHN) to ~$2.5b (lidocaine patch replacement) PHN: Postherpetic Neuralgia
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