Grace Therapeutics : Overview

Published: 2026-04-27 08:18:17 ET GRCE

Published on 04/27/2026 at 08:18 am EDT

Corporate Presentation

April 2026

Executive Summary

GTx-104 | aSAH

Nimodipine is the SoC and clinically de-risked; however, significant unmet needs remain with its only available oral form

GTx-104 - novel intravenous nimodipine - 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

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

aSAH: aneurysmal Subarachnoid Hemorrhage.

All dates based on calendar year in the presentation.

FDA Complete Response Letter (CRL) - Key Findings & Path Forward

CRL driven by CMC data package completeness and manufacturing readiness

Clear path to resolution expected following FDA alignment at Type A meeting

FDA Feedback

Company Assessment

Path Forward

Leachable data

Nonclinical

Manufacturing Facility

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

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

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

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

Hospital-treated aSAH may be as high as ~70k

Literature Estimate

42.5

Claims Analysis 68

0K 25K 50K 75K

Sources: ClearView Analysis (2025). Forian Claims Data. Fletcher Spaght market research; Becske T. (2018). Steven (2020).

Oral Nimodipine - The aSAH Standard of Care for >3 Decades

2023 AHA/ASA Guidelines

For the management of patients with aSAH

Limited use of off-label therapies due to The Joint Commission monitoring adherence to care guidelines

Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). DCI: Delayed Cerebral Infarction

The Joint Commision is a hospital accredation agency

Nimodipine - Consistent Drug Administration Drives Positive Patient Outcomes

Infarction Rates by Nimodipine Dose Reduction Status

Hunt Hess 1-3

Received Reduced Nimodipine Course

Received Full Nimodipine

Course

Hunt Hess 4-5

Received Reduced Nimodipine Course

Received Full Nimodipine

Course

P = 0.037

P = 0.061

0% 25% 50% 75% 100%

Infarction No Infarction

Nimodipine cessation or dose reduction independently associated with poor functional outcomes

(aOR 0.89, 95% CI 0.80-0.99)

Limited use of off-label therapies due to Joint Commission monitoring adherence to care guidelines

Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016).

aOR: adjusted odds ratio; CI: Confidence Interval

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

Sub-optimal Therapeutic B3enefit 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

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

Too High

Increased Hypotension

55% of patients do not receive the full daily dose due to hypotension

Dosing Interruption

Blood Concentration

Sub-optimal Outcomes

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.

GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges Supported by Strong IP, Ph. III Trial Success

GTx-104

A novel intravenous nimodipine that is well positioned to solve oral challenges and potentially displace oral as SoC

Orphan Drug Status with seven-year market exclusivity and additional multi-layered IP protection

Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical evidence of GTx-104 benefit vs. oral

GTx-104 drug delivery technology

Surfactant Monomers

Hydrophilic Part Hydrophobic Part

10- 15 nm

Blank micelles

Nimodipine

Drug loaded micelles

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

CMC: Critical micelle concentration.

GTx-104 Value Proposition

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

Clinical Value

Predictable drug concentration & dose compliance

Reduced drug intake, reduced DDIs & no food effects

More effective hypotension management

Risk of Fatal Parenteral Use

Requires Feeding Tube

Excipient Intolerance

Hemodynamic Control

Dose Compliance

Markets

Nimodipine Capsules

Yes

Poor

U.S. / WW

NYMALIZE

(Oral Liquid)

Yes (Reduced)

Yes

Poor

U.S. /

Select WW

NIMOTOP

(Injectable)

Yes *

Unknown

Rescue Only

EU / China

GTx-104

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

10 WW: Worldwide

DDI: drug-drug internation

Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral Nimodipine

Trial met all primary and secondary endpoints; enabling the 505(b)2 regulatory pathway

GTx-104

Consistent and predictable

plasma concentrations

Significantly lower dose

variability relative to oral capsule

GTx-104 IV infusion vs Oral capsule:

Oral Capsule

GTx-104

AUC Day_3 0-24hr

1000

900

800

700

AUC dav-3 0-24hour

600

500

400

300

200

100

Source: GTx-104-002 CSR; results announced May 2022

STRIVE-ON Phase 3 Trial

GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design

Trial complete and reported topline data in January 2025

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

Onset of aSAH

Screening Period

(within 96 hours of aSAH onset) Day 1

Treatment Period

Day 2-21

Follow up Period

Day 30 and Day 90

Informed Consent

Inclusion/exclusion

Randomize

Initiate investigational product

Hypotension events

Relative dose intensity

Safety

Adverse events

Functional outcomes (mRS)

Pharmacoeconomic outcomes

Primary Endpoint

mRS: modified Rankin Scale

/ Administration Benefits over Current SoC, Oral Nimodipine

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

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

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

Demographics & Baseline Characteristics

Demographics well-balanced, except higher proportion of most severe with worst prognosis (Grade V) in GTx-104

GTX-104 (N = 50)

Oral Nimodipine (N = 52)

Age (mean)

Sex, n (%) Female Male

33 (66.0%)

17 (34.0%)

33 (63.5%)

19 (36.5%)

Hunt & Hess Grade, n (%)

10 (20%)

8 (15%)

15 (30%)

15 (29%)

III

15 (30%)

16 (31%)

6 (12%)

12 (23%)

4 (8%)

1 (2%)

~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

16 five minutes AND requiring medical intervention.

54% of patients on GTx-104 had RDI of 95% or higher versus 8% on Oral Nimodipine

% (N) PATIENTS BY RDI

54% (27)

8% (4)

38% (20)

37% (1G)

14% (7)

18% (G)

17% (G)

GTX- 104 ( N=50 ) ORAL NIMODIPINE ( N=52)

RDI = (total dose administered / total amount of expected dose) * 100.

~29% relative increase in patients with good recovery in GTx-104

CLINICAL OUTCOMES

0% (0)

17% (8)

6% (3)

15% (7)

21% (10)

26% (12)

15% (7)

GTx-104 (N=47*)

~29%

G% (4)

11% (5)

G% (4)

24% (11)

15% (7)

13% (6)

20% (G)

Oral Nimodipine (N=46**)

No Symptoms No Significant Disability Slight Disability Moderate Disability Moderate-Severe Disability Severe Disability Dead

* 3 patients did not complete physician-conducted mRS at day-90. However, all 3 were confirmed alive at day-90

18 ** 6 patients did not complete physician-conducted mRS at day-90. 5 were confirmed alive at day-90, and 1 survival status was unknown

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)

Mobility, n (%)

I have no or some problems I am confined to bed

38 (100%)

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).

19 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).

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

Treatment-Related SAEs, n (%) # of events2

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

Disclaimer

Grace Therapeutics Inc. published this content on April 27, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 27, 2026 at 12:17 UTC.