Company: GRCE
Filing Date: 2025-03-10
Form Type: S-3
Source: 0001140361-25-007769
Chunk: 8

Company: Grace Therapeutics, Inc.
Filing Date: 2025-03-10
Form: S-3
Chunk 8
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 development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials 
 may not be predictive of future trial results. Failure can occur at any stage of clinical development.                       |

| • | We are subject to uncertainty relating to healthcare reform measures and reimbursement policies that, if not favorable to our 
 drug candidates, could hinder or prevent our drug candidates’ commercial success.                                             |

| • | If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell 
 our drug products, if approved, we may be unable to generate any revenue.                                                     |

| • | If we are unable to differentiate our drug products from branded reference drugs or existing generic therapies for similar                                                                                                 
 treatments, or if the FDA or other applicable regulatory authorities approve products that compete with any of our drug products, our ability to successfully commercialize our drug products would be adversely affected. |

| • | Our success depends in part upon our ability to protect our intellectual property for our drug candidates. |

| • | Intellectual property rights do not necessarily address all potential threats to our competitive advantage. |

| • | We do not have internal manufacturing capabilities, and if we fail to develop and maintain supply relationships with various                                                                                                             
 third-party manufacturers, or if such third parties fail to provide us with sufficient quantities of active pharmaceutical ingredients, excipients, or drug products, or fail to do so at acceptable quality levels or prices or fail to 
 maintain or achieve satisfactory regulatory compliance, we may be unable to develop or commercialize our drug candidates.                                                                                                                |

| • | Our manufacturers may encounter difficulties involving, among other things, production yields, regulatory compliance, quality                                                                                                         
 control and quality assurance, as well as shortages of qualified personnel. Approval of our drug candidates could be delayed, limited, or denied if the FDA does not approve and maintain the approval of our contract manufacturer’s 
 processes or facilities.                                                                                                                                                                                                              |

| • | The design, development, manufacture, supply, and distribution of our drug candidates are highly regulated and technically 
 complex.                                                                                                                   |

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You should read this prospectus, the documents that we have incorporated by
          reference into this prospectus, and the documents that we have filed as exhibits to this prospectus completely and with the understanding that our actual future results may be materially different from what we expect.

Except as required by law, we undertake no obligation to update or revise any
          forward-looking statements to reflect new information or future events or developments