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Grace Therapeutics (NASDAQ: GRCE) updates GTx-104 data, FDA CRL response and cash

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(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Grace Therapeutics, Inc. updated its corporate presentation, focusing on GTx-104, a novel intravenous nimodipine for aneurysmal subarachnoid hemorrhage. The FDA issued an April 2026 Complete Response Letter driven by chemistry, manufacturing and controls and contract manufacturer inspection issues, with no clinical deficiencies cited.

A Type A meeting is scheduled to clarify the path to resubmitting the GTx-104 New Drug Application. Phase 3 STRIVE-ON data showed 28% of GTx-104 patients had clinically significant hypotension versus 35% with oral nimodipine capsules, and 54% achieved at least 95% relative dose intensity versus 8% on capsules.

Patients on GTx-104 had 1.5 fewer intensive care unit days on average and 5 fewer days on mechanical ventilation compared with capsules, with overall safety appearing comparable. The company reports orphan drug status for GTx-104, patents extending to 2043, cash of $17.0 M, 16,024,026 common shares outstanding, and fully diluted shares of 23,033,731 as of March 31, 2026.

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Insights

Grace highlights encouraging GTx-104 Phase 3 data while addressing an FDA Complete Response Letter focused on CMC and manufacturing.

The update emphasizes that the FDA’s Complete Response Letter for GTx-104 centers on chemistry, manufacturing and controls, leachables data, and contract manufacturer cGMP observations, with no new clinical safety or efficacy issues identified. A Type A meeting is planned to define requirements for resubmitting the New Drug Application.

Clinically, the STRIVE-ON Phase 3 trial showed lower rates of clinically significant hypotension (28% versus 35%), higher dose intensity (54% versus 8% with near-full dosing), and signals of better 90-day functional outcomes and resource use, while safety profiles were comparable. These results support the rationale for an intravenous nimodipine alternative but are described as not statistically powered for formal comparisons.

Financially, the company reports $17.0 M in cash and cash equivalents and 23,033,731 fully diluted shares as of March 31 2026, plus warrants with potential gross proceeds of $15.0 M if exercised at $3.395 per share. Actual impact on the development path will depend on FDA feedback from the Type A meeting and successful remediation or alternative manufacturing arrangements.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Clinically significant hypotension 28% vs 35% of patients GTx-104 vs oral nimodipine in STRIVE-ON Phase 3
Relative dose intensity ≥95% 54% vs 8% of patients GTx-104 vs oral nimodipine in STRIVE-ON
ICU length of stay 16.4 vs 17.9 days (mean) GTx-104 vs oral nimodipine in aSAH patients
Mechanical ventilation duration 5.6 vs 10.6 days (mean) GTx-104 vs oral nimodipine in STRIVE-ON
Cash and cash equivalents $17.0 M Balance as of March 31, 2026
Common shares outstanding 16,024,026 shares As of March 31, 2026
Fully diluted shares 23,033,731 shares Includes warrants and options as of March 31, 2026
Potential warrant proceeds $15.0 M at $3.395/share Feb 2025 private placement warrants for 4,418,292 shares
Complete Response Letter regulatory
"April 2026 FDA Complete Response Letter received; Company intends to resubmit NDA"
A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.
Type A meeting regulatory
"Type A Meeting Scheduled to Potentially Clarify Path to Resubmission"
A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.
orphan drug status regulatory
"Orphan Drug Status with the potential for seven-year market exclusivity"
An official label from health authorities for medicines that treat very rare diseases, given to encourage development by offering benefits such as reduced fees, tax breaks, and a period of exclusive sales. For investors it matters because these incentives lower development costs and can create a temporary monopoly-like advantage that boosts the drug’s potential revenue and valuation, much like a limited license that makes a risky project more commercially attractive.
aneurysmal Subarachnoid Hemorrhage medical
"aSAH: aneurysmal Subarachnoid Hemorrhage."
Aneurysmal subarachnoid hemorrhage is bleeding into the thin space surrounding the brain caused when a weakened blood vessel balloon (an aneurysm) bursts. Like a burst pipe leaking into a narrow hallway, it can cause sudden, severe damage and often requires urgent surgery or devices and long hospital care. For investors, its frequency, treatment options, and outcomes influence demand for medical devices, drugs, hospital services, clinical trial results and health-care spending.
modified Rankin Scale medical
"mRS: modified Rankin Scale"
A clinical tool that rates a person’s level of disability and dependence following a neurological event, most commonly stroke, on a simple scale from no symptoms to severe disability or death. Think of it as a one-number summary of how independently a patient can live after treatment—an important outcome measure because improvements on this scale often drive whether therapies are seen as effective by regulators, doctors and payers, and therefore influence a drug’s or device’s commercial prospects.
chemistry, manufacturing, and controls technical
"items related to chemistry, manufacturing, and controls (“CMC”) and non-clinical information"
Chemistry, manufacturing, and controls (CMC) is the detailed documentation of how a drug or medical product is made, tested, and kept consistent — like a recipe, factory checklist, and quality-control plan combined. Investors care because strong CMC means regulators are more likely to approve the product and the company can reliably scale production, while weak or incomplete CMC raises the risk of approval delays, production problems, extra costs, or recalls.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What does Grace Therapeutics (GRCE) announce in this 8-K filing?
Grace Therapeutics reports an updated corporate presentation highlighting GTx-104, its intravenous nimodipine program, and the regulatory path after an FDA Complete Response Letter. The company also summarizes Phase 3 STRIVE-ON data, intellectual property, orphan drug status, capitalization, and potential warrant exercise proceeds.

What were the key Phase 3 STRIVE-ON results for GTx-104 reported by GRCE?
In STRIVE-ON, 28% of GTx-104 patients experienced clinically significant hypotension versus 35% on oral nimodipine capsules. Additionally, 54% of GTx-104 patients achieved at least 95% relative dose intensity compared with 8% on capsules, with comparable overall safety and signals of improved functional and resource-use outcomes.

How is the FDA Complete Response Letter affecting Grace Therapeutics’ GTx-104 filing?
The FDA Complete Response Letter for GTx-104 focuses on chemistry, manufacturing and controls, leachables data, nonclinical toxicology assessment, and contract manufacturer cGMP inspection findings. No clinical deficiencies were identified. Grace plans a Type A meeting to clarify requirements and then intends to resubmit the New Drug Application.

What market opportunity does Grace Therapeutics see for GTx-104 in aSAH?
Grace cites U.S. hospital-treated aneurysmal subarachnoid hemorrhage incidence that may be as high as about 70,000 patients annually and highlights high hospitalization charges. GTx-104 aims to address dosing interruptions, hypotension-related limitations, and administration challenges with oral nimodipine in this severe, resource-intensive setting.

What is Grace Therapeutics’ cash position and share count as of March 31, 2026?
As of March 31, 2026, Grace Therapeutics reports cash and cash equivalents of $17.0 M and 16,024,026 common shares outstanding. Fully diluted shares, including pre-funded warrants, common warrants and stock options, total 23,033,731 according to the company’s capitalization table.

What potential warrant proceeds does Grace Therapeutics disclose in this presentation?
The company highlights February 2025 private placement warrants exercisable for 4,418,292 common shares at $3.395 per share. If fully exercised, these warrants would generate potential gross proceeds of approximately $15.0 M, with expiration tied to either 60 days after GTx-104 NDA approval or September 25, 2028.

What additional pipeline programs beyond GTx-104 does Grace Therapeutics describe?
Grace outlines GTx-102, an oral betamethasone spray for Ataxia Telangiectasia with Phase 1 proof-of-concept and FDA guidance for a pivotal trial, and GTx-101, a topical bupivacaine spray for postherpetic neuralgia with completed single-dose Phase 1, both targeting significant unmet neurological pain and movement disorders.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 18, 2026

GRACE THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
001-35776
98-1359336
     
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
     
103 Carnegie Center
Suite 300
Princeton, New Jersey
  
08540
     
(Address of Principal Executive Offices)
  
(Zip Code)

Registrant’s telephone number, including area code: (609) 322-1602

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
GRCE
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
Item 8.01 Other Events.

On June 18, 2026, Grace Therapeutics, Inc. updated its corporate presentation. A copy of the updated corporate presentation is attached hereto as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 8.01.

Item 9.01 Exhibits.

(d) Exhibits

Exhibit
Description
99.1
Corporate Presentation, dated June 17, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     
GRACE THERAPEUTICS, INC.
       
Date:
June 18, 2026
By:
/s/ Prashant Kohli
     
Prashant Kohli
Chief Executive Officer


Exhibit 99.1

 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 in January 2025 
 
 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 arms 
 
 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 (SD)  5.6 (5.7)  10.6 (13.9)  Hospital Readmissions*   One readmission, n (%)   Two readmissions, n (%)    Three readmissions, n (%)   6 (12%)  0  0  7 (14%)  0  1 (2%)  ICU Readmissions   One readmission, n (%)   Two readmissions, n (%)  2 (4%)  0  3 (6%)  1 (2%)  * Hospital Readmissions includes ICU readmissions. Readmissions were due to sequelae of aSAH e.g., UTI (urinary tract infection), DVT (deep vein thrombosis), Pneumonia, Seizures, Hydrocephalus, Cranioplasty.  SD: standard deviation  Trial not statistically powered for hypothesis testing and comparisons between treatment arms 
 
 21  Pharmacoeconomics  Major patient resource utilization drivers in aSAH favor GTx-104  GTx-104  (N = 50)  n*  Nimodipine Oral Capsules  (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%  Comatose  4  0  -100%  5  2  -60%  * Excludes patients that died before Day 14 for this analysis.  Trial not statistically powered for hypothesis testing and comparisons between treatment arms 
 
 Commercial Preparation 
 
 ~45% of treated patients are unconscious or dysphagic (nasogastric tube)  >25% of treated patients have poor dose compliance / blood pressure control   aSAH Market Opportunity  23  Literature, typically limited to basal cistern aSAH (~80% of aSAH), suggests ~42.5K U.S. hospital-treated patients  Claims analysis suggests incidence of hospital-treated aSAH may be as high as ~70K  Addressable Patients  ~50% of patients who survive the initial month remain permanently dependent on a caregiver to maintain daily living  Hospitalization charges can be up to ~$530k for an aSAH patient  aSAH is among the most highly reimbursed Diagnosis-Related Groups (DRGs) in neuro ICU  70% of aSAH Cases Result in Death or Permanent Disability  Most Critical Unmet Needs  Sources: ClearView Analysis (2025). Forian Claims Data. Becske T. (2018). Steven (2020). Hoh (2023). Etminan. JAMA Neurol. 2019; Fegin. The Lancet Neurology. 2009; Labovitz. Neuroepidemiology. 2006; Shea. Neurosurgery. 2007, Linn. Stroke. 1996; Anderson. Stroke. 2000; Daniere. J de Radiologie Diagnostique. 2015; Ingall. Stroke. 1989; Giordan et al. J Neurosurg. 2021; Rinkel et al. Lancet Neurol. 2011; Intl Study of Unruptured Intracranial Aneurysms Investigators. NEJM. 1998. 
 
 24  GTx-104 target product profile 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 events. That is a pretty significant, 19% reduction …”   - Neurointensivist, Stanford University  “… The reduction in hypotensive events is meaningful. I could use it for patients who can not take nimodipine due to hypotensive episodes …”   - Neurointensivist, Mount Sinai  “… I would prefer to use Product X in every patient because one of the biggest reasons to not continue nimodipine is because of hypotension …”   - Neurointensivist, Atlantic Health System  Respondents emphasized that reduction in hypotension is meaningful, as it allows more patients to remain on therapy and avoid dose-limiting side effects   HCPs highlighted that even modest reductions in ICU or ventilator time can have a significant impact on hospital costs, suggesting potential to deliver value beyond drug price—particularly given the high-cost aSAH care settings  Immediate usability without NG tube placement was seen as an advantage, enabling earlier intervention, especially in unstable or intubated patients where time sensitive dosing is key  “… From an economic standpoint, fewer days in the ICU or on a ventilator certainly could justify the cost of the drug. Even a reduction of a single day is relevant. When it gets to be 2 or 3 days, then it’s very impressive ...”   - Neurosurgeon, USC  “… A reduction in ventilator days is great for the patient in reducing their risk of infections and benefitting their financial bottom line. It’s also good for hospital costs …”   - Critical Care Specialist, Intermountain Health  “… Most hospitals are over capacity right now. Any reduction in ICU or ventilator days typically translates to shorter hospital days, which will benefit hospitals overall in terms of costs and resources …”   - Neurointensivist, Boston Medical Center  “… I definitely prefer IVs for critically ill patients than oral. You don’t have to worry about placing down an NG tube …”   - Neurosurgeon, Westchester Medical Center  “… Blood levels are more consistent from one dose to the other, which makes a whole lot of sense since it’s IV. It’s mostly maintaining a therapeutic level and being at the peak of concentration that is a major advantage of IV …”   - Neurosurgeon, UCSF  “… IV would be great because then you don’t have the NG tube anymore or you don’t need to rush for the NG tube because it’s such a pain every time …”   - Neurosurgeon, UCSF  Primary Market Research Insights (2Q 2025)  Sources: Third party conducted interviews, research, and analysis  
 
 Concentration of aSAH Care – Efficient Commercialization   25  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 across 880 centers   ~15 rep sales force to reach ~50% of aSAH patients, concentrated in 242 centers  1 Assumes each sales rep manages ~15 accounts.   Sources: ClearView Analysis (2025). Forian Claims Data.  
 
 Intellectual Property Portfolio  26  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-of-use patents to extend exclusivity beyond what is granted through the orphan drug designation.   Multiple patents granted worldwide, including six patents in the US  Long patent shelf-life   First patent expiry 2037  Newest patent expiry 2043  Continue building our patent portfolio by filing for patent protection on new developments 
 
 Capitalization   Grace Therapeutics, Inc. (GRCE) Cap Table (as of March 31, 2026)  Cash & Cash Equivalents Balance  USD $17.0 M   Outstanding Common Stock  16,024,026  Debt  NONE  Stock options granted and outstanding  1,345,453  Total Fully Diluted Shares Outstanding1  23,033,731  27  1 Includes Pre-Funded Warrants, Common Warrants, Outstanding Stock Options  2 Represents warrants exercisable for 4,418,292 shares of common stock (or pre-funded warrants in lieu thereof) issued on February 11, 2025, with an aggregate exercise price of approximately $15.0 million. The warrants are immediately exercisable at an exercise price of $3.395 per share and will expire on the earlier of (i) the 60th day after the date the FDA approves the New Drug Application for GTx-104 and (ii) September 25, 2028.  Potential Gross Proceeds from Exercise of Outstanding Warrants  Feb-25 Private Placement2: Potential Warrant Exercise Gross Proceeds  $15.0 M 
 
 Experienced Leadership Team  28  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. Rabinstein, MD  Alex Choi, MD  Andrew Ducruet, MD  Sherry H-Y Chou, MD  W. Taylor Kimberly, MD, PhD  Management Team  Scientific Advisory Board  Deep aSAH Expertise in Research, Commercial, Drug & AHA Care Guidelines Development 
 
 Appendix (Deprioritized Programs) 
 
 30  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 all outcome measures  Sources: Fletcher Spaght market research; National Organization for Rare Disorders (NORD); Lefton-Greif (2000); U.S. National Cancer Institute, A-T (2015).  Unmet Need (No drugs approved)   Treatment primarily directed toward control of symptoms  Limited to speech, occupational and physical therapy  Less than 20% of patients on any type of drug therapy for A-T symptoms   Ataxia-Telangiectasia  Complex genetic neurodegenerative disorder diagnosed during infancy  Inherited as an autosomal recessive trait, often affects more than one child in a family  Average lifespan ~25 years   Potential addressable market ~$150 million  Regulatory   FDA’s written responses to EoP1 provides feedback on design of a single pivotal efficacy trial to support NDA  Guidance includes primary endpoint scale and appropriate confirmatory evidence  Plan to discuss with SAB potential trial design 
 
 31  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   Sources: Fletcher Spaght, Inc. analysis (2022); CDC MMWR June 6, 2008. UK and several US states have reclassified gabapentin as a scheduled drug  Unmet Need  Oral therapies (gabapentin, anticonvulsants, opioids) can have side effects and insufficient to manage pain in many cases  Can be prone to abuse  Lidocaine patches are hard to place, can cause skin irritation, are 12-hour on / off   ~40% experience insufficient pain relief   Postherpetic Neuralgia (rare disease)  Caused by nerve damage from the herpes zoster virus which causes shingles   Burning, painful, itchy, loss of feeling, sensitivity to touch or temperature, feeling worn out   Symptoms can last for several years or may be permanent   Regulatory   Completed Phase 1 (single dose) in 2022   Met all primary outcome measures   Clinical roadmap includes Phase 1 (multiple ascending dose) and Phase 2 (POC) 
 

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