Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 128

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 128
---
 necessary regulatory approvals could be delayed or prevented. If LNHC initiates clinical trials, it may find it difficult to adequately enroll patients. If LNHC encounters such difficulties enrolling patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected. Patient enrollment is a significant factor in the timing of clinical trials, and the timing of LNHC’s clinical trials may depend, in part, on the speed at which it can recruit patients to participate in such trials, as well as completion of required follow-up periods. LNHC may not be able to initiate or continue clinical trials for any future product

71

TABLE OF CONTENTS

candidate if is unable to locate and enroll a sufficient number of eligible patients to participate in these trials through such trial’s conclusion as required by the FDA or other comparable regulatory authorities. The eligibility criteria of LNHC’s clinical trials, once established, may further limit the pool of available trial participants. Patient enrollment in clinical trials may be affected by other factors, including:

| • | size and nature of the targeted patient population; |

| • | severity of the disease or condition under investigation; |

| • | availability and efficacy of approved therapies for the disease or condition under investigation; |

| • | patient eligibility criteria for the trial in question as defined in the protocol; |

| • | perceived risks and benefits of the product candidate under study; |

| • | clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any products that may be approved for, or any product candidates under investigation for, the indications LNHC is investigating; |

| • | efforts to facilitate timely enrollment in clinical trials; |

| • | patient referral practices of physicians; |

| • | the ability to monitor patients adequately during and after treatment; |

| • | proximity and availability of clinical trial sites for prospective patients; |

| • | continued enrollment of prospective patients by clinical trial sites; and |

| • | the risk that patients enrolled in clinical trials will drop out of such trials before completion. |

Additionally, other pharmaceutical companies may compete for enrollment of targeted patient population, which may make it more difficult to fully enroll any clinical trials. LNHC would also rely on CROs and clinical trial sites to ensure proper and timely conduct of any clinical trials and preclinical studies. LNHC may have limited influence over such parties’ actual performance. LNHC’s inability to enroll a sufficient number of patients in its clinical trials would result in significant delays or may require it