Company: GRCE
Filing Date: 2025-03-10
Form Type: S-3
Source: 0001140361-25-007769
Chunk: 6

Company: Grace Therapeutics, Inc.
Filing Date: 2025-03-10
Form: S-3
Chunk 6
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 convenient drug delivery that can result in increased patient compliance;   |

| • | the potential for our drug candidates to receive orphan drug designation and exclusivity from the United States FDA or     
 regulatory approval under the Section 505(b)(2) regulatory pathway under the Federal Food, Drug and Cosmetic Act (“FDCA”); |

| • | the future prospects of our GTx-104 drug candidate, including but not limited to GTx-104’s potential to be administered to                                                                                                                    
 improve the management of hypotension in patients with aneurysmal subarachnoid hemorrhage (“aSAH”); the ability of GTx-104 to achieve a pharmacokinetic (“PK”) and safety profile similar to the oral form of nimodipine; GTx-104’s potential 
 to provide improved bioavailability; GTx-104’s potential to achieve pharmacoeconomic benefit over the oral form of nimodipine; our ability to ultimately file a new drug application (“NDA”) for GTx-104 under Section 505(b)(2) of the FDCA; 
 the acceptance of the NDA by the FDA; and the timing and ability to receive FDA approval for marketing GTx-104;                                                                                                                               |

| • | our plan to prioritize the development of GTx-104; |

| • | our plan to maximize the value of our de-prioritized drug candidates, GTx-102 and GTx-101, including through potential 
 development, licensing, or sale of those drug candidates;                                                              |

| • | the future prospects of our GTx-102 drug candidate, including but not limited to GTx-102’s potential to provide clinical                                                                                                                  
 benefits to decrease symptoms associated with Ataxia Telangiectasia; GTx-102’s potential ease of drug administration; the timing and outcomes of a Phase 3 efficacy and safety study for GTx-102; the timing of an NDA filing for GTx-102 
 under Section 505(b)(2) of the FDCA; and the timing and ability to receive FDA approval for marketing GTx-102;                                                                                                                            |

| • | the future prospects of our GTx-101 drug candidate, including but not limited to GTx-101’s potential to be administered to                                                                                                                     
 postherpetic neuralgia (“PHN”) patients to treat the severe nerve pain associated with the disease; assumptions about the biphasic delivery mechanism of GTx-101, including its potential for rapid onset and continuous pain relief