Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 567

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 567
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 patients are experiencing nausea. Under the terms of the Benuvia License Agreement, Benuvia
will be responsible for the manufacturing and supply of the Spray Formulations, but we will have exclusive, worldwide rights to
develop, commercialize and distribute the Spray Formulations.

In
connection with the Benuvia License Agreement, we agreed to pay Benuvia a six and one-half percent (6.5%) royalty on net sales
of the Spray Formulations for a period of up to 15 years from the date of the first commercial sale of any of the Spray Formulations.
In addition, on December 23, 2023, we entered into a stock issuance agreement with Benuvia pursuant to which we issued to Benuvia
384,226 shares of our Common Stock, which may be offered and sold pursuant to the resale prospectus which forms a part of the
Registration Statement.

While
we currently do not have strategy and development plans for the Spray Formulations licensed from Benuvia, beginning in the first
quarter of 2025, we plan to develop clinical programs for each of the Spray Formulations, determine the labelling strategy that
would be obtained from completion of these programs and discuss with the FDA the requirements for bringing each of the Spray Formulations
to market. We anticipate bringing the Spray Formulations to market through the FDA 505(b)(2) regulatory pathway for new drug applications;
however, the exact details will require further consultation with the FDA.

74 

Going
Concern

For
the years ended December 31, 2024 and 2023, we had a net loss of approximately $8.0 million and approximately $7.4 million, respectively,
and will require additional capital in order to operate in the normal course of business and fund clinical studies. The IPO closed
on February 21, 2024, from which, the Company received net proceeds from the IPO of approximately $5.7 million after deducting
the underwriting discounts and commissions and offering expenses payable by the Company (excluding any exercise of the warrants
issued to A.G.P./Alliance Global Partners (the “Representative”)
or its designees, in connection with the IPO).

Based
on the Company’s current projections, management believes there is substantial doubt about its ability to continue to operate
as a going concern and fund its operations through at least the next twelve months following the issuance of these consolidated
financial statements. While the Company will continue to invest in its business and