Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 118

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 118
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 and regulations, or LNHC’s inability to execute such activities, could impact the commercialization timelines of LNHC’s ZELSUVMI product and/or any future product candidate, as well as increase costs. Further, if LNHC does not appropriately coordinate with, project manage, or provide adequate internal expertise, resources and documentation with LNHC’s third-party drug product manufacturer, LNHC may not be successful, or may be delayed, in the commercialization of ZELSUVMI. LNHC has a limited number of personnel who have experience in drug substance manufacturing and possess the expertise necessary to manufacture berdazimer sodium.**

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Orion Corporation (“Orion”), with whom LNHC has formed a strategic alliance to manufacture the commercial drug product for ZELSUVMI, including final fill/finish and packaging, must be successful in its execution of LNHC’s commercial production strategy. For instance, LNHC may not be successful in realizing the intended operating goals from this arrangements based on a number of factors, including, among other things, (i) delays or failures, including delays in LNHC ability to transition applicable technology and processes to our vendors or partners, (ii) reduced quality, (iii) delayed receipt of goods or services, (iv) increased and unexpected costs on the part of the third-party vendors or strategic partners, and (v) certain incremental and discrete costs to effect this strategy. If LNHC is unsuccessful in partnering with third-party manufacturers, it could experience delays in the development and commercialization timelines of its product candidates, as well as increased costs. LNHC will also have no direct control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or any comparable foreign regulatory authority does not approve these facilities for the manufacture of LNHC’s products, or if such authorities withdraw any such approval in the future, LNHC may be required to find alternative manufacturing facilities, which would significantly impact its ability to obtain approval of and commercialize any product candidates, if approved. LNHC’s failure, or the failure of any of its third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on LNHC, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect LNHC’s financial position. LNHC’s or a third party’s failure to execute on LNHC’s manufacturing