Full Press Release Details
Corporate Presentation June 2026
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, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and
unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics, Inc. (the "Company") to be materially different from historical results or from any future results expressed or implied by such
forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates,"
"estimates," "potential," "should," "may," "will," "plans," "continue," "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date of this presentation. The forward-looking statements in this presentation, including, but not limited to, statements regarding the Company's belief that it can address the items related to chemistry, manufacturing,
and controls ("CMC") and non-clinical information cited in the U.S. Food and Drug Administration's ("FDA") Complete Response Letter ("CRL") in a resubmission of its New Drug Application ("NDA") for GTx-104; the expected timing and outcome of
the Type A meeting scheduled with the FDA related to the CRL; the Company's expectations that such Type A meeting with the FDA will clarify the path forward and determine next steps for GTx-104; the Company's plans to provide a regulatory
update after the receipt of the official meeting minutes from such Type A meeting; expected cash runway; the potential exercise of outstanding warrants; the future prospects of the Company's GTx-104 drug candidate; GTx-104's potential to
bring enhanced treatment options to patients suffering from aneurysmal subarachnoid hemorrhage ("aSAH"); GTx-104's potential to be administered to improve the management of hypotension in patients with aSAH; gastrointestinal intolerance and
dosing consistency compared with oral administration; the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to oral formulations of nimodipine; GTx-104's potential to provide improved bioavailability and the potential
for reduced use of rescue therapies; GTx-104's potential to achieve medical and pharmacoeconomic benefit over oral formulations of nimodipine; GTx-104's commercial prospects; the Company's pre-commercial launch strategy for GTx104; the future
prospects of the Company's GTx-102 drug candidate; GTx-102's potential to provide clinical benefits to decrease symptoms associated with Ataxia Telangiectasia; the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-102; the
timing of an NDA filing for GTx-102; the future prospects of the Company's GTx-101 drug candidate; GTx-101's potential to be administered to Postherpetic Neuralgia ("PHN") patients to treat severe nerve pain associated with the disease; the
timing and outcomes of a Phase 3 efficacy and safety trial for GTx-101; the size of the addressable market for GTx-104 and GTx 102, and any future patent and other intellectual property filings made by the Company for new developments, are
based upon Grace Therapeutics, Inc.'s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such
forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the outcome of any Type A meeting with the FDA related to GTx-104; (ii) the timing and success of any regulatory resubmission of the
NDA for GTx-104; (iii) changes to regulatory requirements or regulatory pathways; (iv) the Company's ability to protect its intellectual property rights for its product candidates; and (v) legislative, regulatory, political and economic
developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere,
including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2026, and other documents that have been and will be filed by Grace Therapeutics, Inc. from time to time with the Securities and Exchange Commission and Canadian securities regulators. All
forward-looking statements contained in this presentation speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after
the date on which they were made, except as required by applicable securities laws.
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 available oral formulations Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical
evidence of GTx-104 benefit vs oral capsules 3 Executive Summary aSAH: aneurysmal Subarachnoid Hemorrhage. All dates based on calendar year in the presentation. GTx-104 | aSAH Potential to address a severe rare disease with efficient
commercial organization; concentrated patient care Orphan Drug Status with the potential for seven-year market exclusivity and additional multi-layered IP protection Regulatory Update April 2026 FDA Complete Response Letter
received; Company intends to resubmit NDA following resolution of cited items
4 FDA Complete Response Letter (CRL) - Key Findings & Path Forward CRL
driven by CMC data package completeness and manufacturing readiness No clinical deficiencies identified Type A Meeting Scheduled to Potentially Clarify Path to Resubmission FDA Feedback Company Assessment Path Forward Leachable
data Insufficient baseline and longitudinal data from intended commercial CDMO Dataset completeness related to commercial CDMO Existing intermediate and long-term data generation already in place No indication of new safety
signal Generate baseline data from commercial site Complete ongoing longitudinal dataset to support full shelf-life characterization Align dataset and analytical approach with FDA expectations Nonclinical Unable to complete tox risk
assessment without leachable dataset from CDMO Additional assessment of excipient (Alcohol, USP) exposure requested. Maximum daily exposure of alcohol in drug product is within FDA inactive ingredient database Dependent on completion of
leachable dataset Alcohol concentration is less than 2% in infusion solution No novel excipient used in drug product No standalone tox signal identified Complete tox assessment based on updated leachable dataset from CDMO Conduct
targeted preclinical study for excipient duration of exposure as required Manufacturing Facility Deficiencies identified during cGMP inspection of CDMO Manufacturing compliance observations requiring remediation No product-specific
quality issues identified Ongoing remediation activities at CDMO Potential reinspection prior to approval Evaluating manufacturing alternatives to support supply and regulatory readiness
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 surgical
intervention and oral nimodipine therapy 5 Sources: ClearView Analysis (2025). Forian Claims Data. Fletcher Spaght market research; Becske T. (2018). Steven (2020). Occurs in Relatively Young Patients (~50% <60 yrs) Significant
Mortality (~10-15% before reaching hospital) Est. Annual U.S. Hospital-Treated Patients (2023) Hospital-treated aSAH may be as high as ~70k
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 approved therapy
to improve neurological outcomes Limited use of off-label therapies due to The Joint Commission monitoring adherence to care guidelines
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
0.80-0.99) P = 0.037 P = 0.061 Received Reduced Nimodipine Course Received Full Nimodipine Course Received Reduced Nimodipine Course Received Full Nimodipine Course Hunt Hess 1-3 Hunt Hess 4-5 Nimodipine is administered six times per
day for up to 21 days Limited use of off-label therapies due to Joint Commission monitoring adherence to care guidelines
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 patients receive
nimodipine through nasogastric tube (NGT) - often via capsule extraction Capsule extraction and administration is labor intensive Dosing Interruption Increased Hypotension Too High Fatal Medication Errors Inadvertent parenteral
injection can result in death or serious life-threatening AEs Highest risk with capsule extraction NYMALIZE (oral liquid) tempers the risk of error, but has tolerability challenges (e.g., severe diarrhea) due to solubility limitations of
nimodipine 3 Sub-optimal Therapeutic Benefit with Oral Administration High Pharmacokinetic Variability Inconsistent plasma concentration in both inter and intra subject High first-pass metabolism, leads to low bioavailability and
frequent dosing Gastric motility issues and presence of food delay rate of absorption Potentially negligible concentration with NGT administration Hypotension drives missed doses and diminished efficacy Blood Concentration 55% of
patients do not receive the full daily dose due to hypotension Sub-optimal Outcomes Too Low
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 the potential for seven-year market exclusivity and additional multi-layered IP protection Drug loaded micelles Nimodipine 10-
15 nm Blank micelles Surfactant Monomers Hydrophilic Part Hydrophobic Part A novel intravenous nimodipine that is well positioned to solve oral challenges and potentially displace oral as SoC Pivotal Phase 3 STRIVE-ON safety trial met
primary endpoint; clinical evidence of GTx-104 benefit vs. oral capsules GTx-104 Overcomes solubility limitations of nimodipine in current formulations Patented formulation uses non-ionic surfactant micelles as the drug carrier to
solubilize nimodipine Simple to prepare in pharmacy, stable at room temperature GTx-104 drug delivery technology
Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral
Nimodipine 10 Source: GTx-104-002 CSR; results announced May 2022 Observed lower dose variability relative to oral capsule Consistent and predictable plasma concentrations GTx-104 IV infusion vs Oral Capsule: AUC Day 3
0-24hr GTx-104 Oral Capsule 0 100 200 300 400 500 600 700 800 900 1000 AUC dav-3 0-24hour GTx-104 Trial met all primary and secondary endpoints; enabling the 505(b)2 regulatory pathway
STRIVE-ON Phase 3 Trial
GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design 12 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 nimodipine oral capsules in patients hospitalized for aSAH Screening Period (within 96 hours of
aSAH onset) Day 1 Treatment Period Day 2-21 Onset of aSAH Follow up Period Day 30 and Day 90 Primary Endpoint Incidence of subjects with at least one episode of clinically significant hypotension Informed
Consent Inclusion/exclusion Randomize Initiate investigational product Hypotension events Relative dose intensity Safety Adverse events Functional outcomes (mRS) Pharmacoeconomic outcomes Trial complete and reported topline data
13 STRIVE-ON Trial Data Support Potential Clinical, Pharmacoeconomic, and
Dosing / Administration Benefits over Current SoC, Nimodipine Oral Capsules CLINICAL 90-DAY OUTCOMES (MRS*) +29% relative increase in patients with good recovery at 90 days vs. oral capsules HYPOTENSION EVENTS -19% reductionfrom oral
capsules DOSE INTENSITY 54% vs. 8% with oral capsules receive >95% prescribed dose PHARMACOECONOMIC ICU DAYS -1.5 days reduction from oral capsules TIME ON VENTILATION -5 days reduction from oral capsules ICU READMISSION
RATES -48% reductionfrom oral capsules DOSING & ADMIN. PATIENT REST No need to disrupt patient sleep every 4 hours ADMINISTRATION No feeding tube or swallowing of large pills required TREATMENT PREP No nimodipine capsule
extraction and administration (laborious for staff) * mRS: modified Rankin Score Trial not statistically powered for hypothesis testing and comparisons between treatment arms
14 Demographics & Baseline Characteristics GTx-104 (N = 50) Nimodipine
Oral Capsules (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%) Demographics well-balanced, except higher proportion of most severe with worst prognosis (Grade V) in GTx-104
15 Primary Endpoint - Clinically Significant Hypotension ~19% relatively
fewer patients with clinically significant hypotension in GTx-104 GTx-104 (N = 50) n (%) Nimodipine Oral Capsules (N = 52) n (%) Clinically Significant Hypotension* 14 (28%) 18 (35%) * Clinically significant hypotension: decrease in
systolic BP > 20 mm Hg or diastolic BP > 10 mm Hg or systolic BP <= 100 confirmed by two consecutive readings within five minutes AND requiring medical intervention. Trial not statistically powered for hypothesis testing and
comparisons between treatment arms
16 Relative Dose Intensity (RDI) 54% of patients on GTx-104 had RDI of 95% or
higher versus 8% on Nimodipine Oral Capsules GTx-104 Nimodipine Oral Capsules RDI: (total dose administered / total amount of expected dose) * 100 Trial not statistically powered for hypothesis testing and comparisons between treatment
17 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 alive at
day-90, and 1 survival status was unknown Trial not statistically powered for hypothesis testing and comparisons between treatment arms
18 Clinical Outcomes - QoL (Quality of Life; day 90) Patient-reported health
scores favor GTx-104 QoL GTx-104 (N = 381) Nimodipine Oral Capsules (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 (12%) Self-Care, n (%) I have no or some problems I am unable to wash/dress 37 (97%) 1 (2.6%) 35 (88%) 5 (12%) Usual Activities, n (%) I have no or some problems I am unable to perform 35 (92%) 3
(8%) 33 (84%) 7 (16%) Pain/Discomfort, n (%) I have no or moderate pain I have extreme pain 36 (95%) 2 (5%) 38 (95%) 1 (2%) Anxiety/Depression, n (%) I am not or moderately I am extremely 36 (95%) 2 (5%) 36 (90%) 3
(7%) 1 GTx-104: patient did not complete survey (4), dead (8 - all due to underlying disease, none were GTx-104 related). 2 Nimodipine Oral Capsules: patient did not complete survey (8), dead (4 - all due to underlying disease, none were
related to oral capsules). Oral also had 2 incomplete (pain, anxiety). Trial not statistically powered for hypothesis testing and comparisons between treatment arms
19 Safety Overall safety was comparable between the two groups Summary of
Adverse Events (AEs) (entire study duration of 90 days) GTx-104 (N = 50) Nimodipine Oral Capsules (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 (48%) 48 All SAEs, events per n 1.9 1.9 Treatment-Related SAEs, n (%) # of events2 0 2 (4%) 2 Mortality3, n (%) 8 (16%) 4 (8%) Cause of death4 (n) All deaths were due to severity of underlying disease No deaths due to
GTx-104 - aSAH (5), ICH (1), rebleed (1), cardiac arrest (1) No deaths due to Nimodipine Oral Capsules - aSAH (2), rebleed (1), cardiac arrest (1) 1 A few include sepsis, deep vein thrombosis, ICH, hydrocephalus, cerebral infarction,
urinary tract infection, C. difficile, systemic inflammatory response, acute kidney injury, as well as death 2 Nimodipine Oral Capsules: bradycardia, vasospasm 3 Mortality rate is equivalent or lower than previous well-controlled
clinical trials (Oral NIMOTOP NDA) 4 Based on investigator assessment SAEs: Serious Adverse Events; ICH: Intracerebral Hemorrhage; DCI: Delayed Cerebral Hemorrhage
20 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) Nimodipine Oral Capsules (N = 52) ICU los, days Mean (SD) 16.4 (6.7) 17.9 (10.4) Mechanical Ventilation days Mean