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Grace Therapeutics (GRCE) outlines GTx-104 CRL, Phase 3 data and cash

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8-K

Rhea-AI Filing Summary

Grace Therapeutics, Inc. updated its corporate presentation to highlight regulatory status, clinical data and capital position. The company received an FDA Complete Response Letter for its GTx-104 intravenous nimodipine NDA, driven by chemistry, manufacturing and controls and manufacturing facility issues, with no clinical deficiencies cited. Management plans a Type A FDA meeting and additional leachable and toxicology work, while evaluating manufacturing alternatives. Phase 3 STRIVE-ON data in aneurysmal subarachnoid hemorrhage showed fewer hypotension events, higher relative dose intensity and signals of better 90‑day outcomes and resource use versus oral nimodipine. The deck also notes orphan drug status and patents for GTx-104, additional programs GTx-102 and GTx-101, cash of $18.7 million and potential $15.0 million of gross proceeds from outstanding warrants.

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Insights

FDA CRL delays GTx-104 approval but leaves efficacy intact.

The presentation explains that GTx-104’s NDA drew an FDA Complete Response Letter focused on chemistry, manufacturing and controls, leachable data and CDMO cGMP observations. Importantly, the company reports no clinical deficiencies, so the Phase 3 safety and efficacy package remains usable.

Grace plans a Type A meeting, more leachable testing, targeted toxicology and remediation or alternatives for manufacturing. These steps can be substantial in workload and time, but they are framed as addressable process issues rather than requiring new efficacy trials, based on the provided text.

The STRIVE-ON Phase 3 trial showed fewer hypotension events, higher relative dose intensity, favorable 90‑day functional outcomes and shorter ICU and ventilation time versus oral nimodipine. If the regulatory and manufacturing items are resolved, these data and orphan exclusivity could support a differentiated launch, but timing is not specified in the materials.

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.
GTx-104 FDA status Complete Response Letter NDA feedback focused on CMC, leachables and manufacturing
Cash and cash equivalents $18.7 M Balance as of December 31, 2025
Common shares outstanding 15,474,026 shares As of December 31, 2025
Fully diluted shares 22,993,731 shares Includes pre-funded warrants, common warrants and options
Warrant exercise proceeds $15.0 M Potential gross proceeds from Feb 2025 private placement warrants
Warrant exercise price $3.395/share Exercise price for 4,418,292 shares under Feb 2025 warrants
Clinically significant hypotension 28% vs 35% GTx-104 vs oral nimodipine in STRIVE-ON primary endpoint
ICU length of stay 16.4 vs 17.9 days Mean ICU stay, GTx-104 vs oral nimodipine
Complete Response Letter regulatory
"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
"intends to request a Type A meeting with the FDA to clarify the path forward"
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 seven-year market exclusivity and additional multi-layered IP protection"
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.
Relative Dose Intensity financial
"RDI = (total dose administered / total amount of expected dose) * 100"
postherpetic neuralgia medical
"GTx-101 ... to be administered to Postherpetic Neuralgia (“PHN”) patients to treat severe nerve pain"
chemistry, manufacturing, and controls regulatory
"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.
Understanding 8-K Material Events →
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): April 27, 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 April 27, 2026, Grace Therapeutics, Inc. (the “Company”) updated its corporate presentation. A copy of the updated corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

Item 9.01.
Financial Statements and Exhibits.

(d) Exhibits

Exhibit
  
Description
99.1
  
Corporate Presentation, dated April 27, 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:
April 27, 2026
By:
/s/ Prashant Kohli
     
Prashant Kohli
Chief Executive Officer


Exhibit 99.1

 Corporate Presentation   April 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 in a resubmission of its New Drug Application (“NDA”) for GTx-104; the Company’s intentions to request a Type A meeting with the FDA to clarify the path forward and determine the appropriate next steps for GTx-104 and the expected outcome of 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 the oral form 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 the oral form 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 success and timing of any regulatory resubmission related to the STRIVE-ON Phase 3 safety trial for GTx-104; (ii) changes to regulatory requirements or regulatory pathways; (iii) the Company’s ability to protect its intellectual property rights for its product candidates; and (iv) 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, 2025, Quarterly Reports on Forms 10-Q for the quarterly periods ended June 30, 2025, September 30, 2025 and December 31, 2025 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 its only available oral form  Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical evidence of GTx-104 benefit vs oral  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 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   Clear path to resolution expected following FDA alignment at Type A meeting  FDA Feedback  Company Assessment  Path Forward  Leachable data  Insufficient baseline and longitudinal data from intended commercial site  Dataset completeness related to commercial site  Existing intermediate and long-term data generation 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  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 data   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 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  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 
 
 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 *  Unknown  Rescue Only  EU / China  GTx-104  No  No  No  Optimal  Optimal  Global Rights  Sources: Nimodipine capsule packaging insert. Fletcher Spaght market research. Soppi V. (2007).   * High alcohol content (~24% volume/volume) also requires central catheter for administration  WW: Worldwide   DDI: drug-drug internation   Predictable drug concentration & dose compliance  Reduced drug intake, reduced DDIs & no food effects  More effective hypotension management  Clinical Value  Hospital Value  Reduced hospital resources  The Joint Commission compliance to aSAH care guidelines   Reduced medication errors & nursing burden  Patient Value  Lower disease burden & faster recovery  Safer & more convenient treatment  Improved functional outcomes 
 
 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  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  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 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 
 
 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%   reduction from oral nimodipine  BETTER RELATIVE DOSE INTENSITY  54% vs. 8% with oral nimodipine receive >95% prescribed dose  PHARMACOECONOMIC  FEWER ICU   DAYS  -1.5 days  reduction from oral nimodipine  LESS TIME ON   VENTILATION  -5 days   reduction from oral nimodipine  REDUCED ICU   READMISSION RATES  -48%   reduction from oral nimodipine  DOSING & ADMIN.  IMPROVED PATIENT   REST  No need to disrupt patient sleep every 4 hours  EASIER   ADMINISTRATION  No feeding tube or swallowing of large pills required  LESS LABOR-INTENSIVE TREATMENT PREP  No nimodipine capsule extraction and administration (laborious for staff)  * mRS – modified Rankin Score  
 
 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%)  Demographics well-balanced, except higher proportion of most severe with worst prognosis (Grade V) in GTx-104 
 
 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 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. 
 
 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. 
 
 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 alive at day-90, and 1 survival status was unknown  
 
 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 (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 Oral Nimodipine: patient did not complete survey (8), dead (4 – all due to underlying disease, none were Oral Nimodipine related). Oral also had 2 incomplete (pain, anxiety).  
 
 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 (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 Oral Nimodipine  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 Oral Nimodipine: 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 
 
 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)  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 
 
 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%  Comatose  4  0  -100%  5  2  -60%  * Excludes patients that died before Day 14 for this analysis. 
 
 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  24  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. 
 
 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 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 the reduction in hypotension with GTx-104 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 GTx-104’s potential to deliver value beyond drug price—particularly given the high-cost aSAH care settings  GTx-104’s 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   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 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  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-of-use patents to extend exclusivity beyond what is granted through the orphan drug designation.   Multiple patents granted worldwide, including five 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 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 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  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. 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) 
 
 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 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 
 
 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   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) 
 


Source: View Original Filing on SEC EDGAR

FAQ

What did Grace Therapeutics (GRCE) disclose about the FDA review of GTx-104?

Grace reported an FDA Complete Response Letter for GTx-104 focusing on CMC data, leachables and manufacturing facility deficiencies. The company states no clinical deficiencies were identified and plans a Type A meeting and additional studies before resubmitting its New Drug Application.

How did GTx-104 perform versus oral nimodipine in the STRIVE-ON Phase 3 trial for aSAH?

GTx-104 showed fewer clinically significant hypotension events and higher relative dose intensity than oral nimodipine. The presentation also notes a roughly 29% relative increase in patients with good 90‑day recovery, fewer ICU days, fewer ventilator days and lower ICU readmission rates in the GTx-104 arm.

What market opportunity does Grace Therapeutics (GRCE) see for GTx-104 in aneurysmal subarachnoid hemorrhage?

Grace cites U.S. hospital-treated aSAH incidence potentially as high as about 70,000 patients annually, with high hospitalization charges and significant long-term disability. It positions GTx-104 as an IV alternative to oral nimodipine, targeting improved tolerability, dosing consistency and pharmacoeconomic benefits.

What is Grace Therapeutics’ cash position and capital structure as of December 31, 2025?

The company reports cash and cash equivalents of $18.7 M, 15,474,026 common shares outstanding and 1,305,453 stock options granted. Fully diluted shares total 22,993,731, including warrants and options, giving a snapshot of current capitalization and potential future dilution.

What potential additional funding could Grace Therapeutics (GRCE) receive from outstanding warrants?

Grace highlights a February 2025 private placement with warrants exercisable for 4,418,292 common shares at $3.395 per share. If fully exercised, these warrants could generate about $15.0 M in gross proceeds, subject to their terms and future exercise decisions.

Which additional drug candidates besides GTx-104 are in Grace Therapeutics’ pipeline?

The deck describes GTx-102, an oral spray betamethasone for Ataxia Telangiectasia with FDA end-of-Phase 1 feedback, and GTx-101, a topical bupivacaine spray for postherpetic neuralgia that completed a Phase 1 trial. Both target unmet needs and sizeable rare disease or pain markets.

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