Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 132

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 132
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 authorities may disagree with LNHC regarding the formulation, labeling and/or product specifications; |

| • | approval may be granted only for indications that are significantly more limited than those LNHC seeks, and/or may include significant restrictions on distribution and use; |

| • | such authorities may find deficiencies in the manufacturing processes or facilities of the third-party manufacturers utilized for clinical and commercial supplies; or |

| • | such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission. |

Even if LNHC eventually completes clinical testing and receives approval of an NDA, sNDA or foreign marketing application for any product candidates, the FDA or the applicable foreign regulatory agency may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including post-market clinical trials. Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization would delay or prevent commercialization of that product candidate and would materially adversely impact LNHC’s business and prospects. In addition, the FDA and other regulatory authorities may change their policies, issue additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval of LNHC’s products under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon LNHC that could delay its ability to obtain approvals, increase the costs of compliance or restrict its ability to maintain any marketing authorizations that it may have obtained. Furthermore, even if LNHC obtains regulatory approval for any product candidates, LNHC will still need to establish a commercially viable pricing structure and obtain approval for adequate reimbursement from third-party and government payors. If LNHC is unable to successfully commercialize any future product candidates, LNHC may not be able to generate sufficient revenue to continue its business. LNHC will be subject to ongoing regulatory obligations and continued regulatory review with respect to ZELSUVMI and any future product candidates that receive regulatory approval, which may result in significant additional expense. For ZELSUVMI and any regulatory approvals that LNHC may receive for its future product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for its products and any future product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCPs for any clinical trials. In addition, manufacturers of drug products and their facilities are subject to continual review and