Company: GRCE
Filing Date: 2025-03-10
Form Type: S-3
Source: 0001140361-25-007769
Chunk: 7

Company: Grace Therapeutics, Inc.
Filing Date: 2025-03-10
Form: S-3
Chunk 7
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 eight hours; and the timing and outcomes of single ascending dose/multiple ascending dose and PK bridging studies, and a Phase 2 and Phase 3 efficacy and safety study; the timing of an NDA filing for GTx-101 under Section 505 (b)(2) of    
 the FDCA; and the timing and ability to receive FDA approval for marketing GTx-101;                                                                                                                                                            |

| • | the quality of our clinical data, the cost and size of our development programs, expectations and forecasts related to our                                                                                                                    
 target markets and the size of our target markets; the cost and size of our commercial infrastructure and manufacturing needs in the United States, European Union, and the rest of the world; and our expected use of a range of third-party 
 contract research organizations and contract manufacturing organizations at multiple locations;                                                                                                                                               |

| • | expectations and forecasts related to our intellectual property portfolio, including but not limited to the probability of                                                                  
 receiving orphan drug exclusivity from the FDA for our leading pipeline drug candidates; our patent portfolio strategy; and outcomes of our patent filings and extent of patent protection; |

| • | our intellectual property position and duration of our patent rights; |

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TABLE OF CONTENTS

| • | our strategy, future operations, prospects, and the plans of our management with a goal to enhance stockholder value; |

| • | our need for additional financing, and our estimates regarding our operating runway and timing for future financing and capital 
 requirements;                                                                                                                   |

| • | our expectations regarding our financial performance, including our costs and expenses, liquidity, and capital resources; |

| • | our projected capital requirements to fund our anticipated expenses; and |

| • | our ability to commercialize GTx-104 in the United States or establish strategic partnerships or commercial collaborations or 
 obtain non-dilutive funding.                                                                                                  |

Although the forward-looking statements in this prospectus are based upon what we believe are reasonable assumptions, you should not place undue reliance on those forward-looking statements since actual results may vary materially from them. In addition, the forward-looking statements in this prospectus are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond our control, that could cause our actual results and developments to differ materially from those that are disclosed in or implied by the forward-looking statements, including, among others:

| • | We are heavily dependent on the success of our lead drug candidate, GTx-104. |

| • | Clinical