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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 2, 2025
Pelthos
Therapeutics Inc.
(Exact name of registrant as specified in
its charter)
| Nevada |
|
001-41964 |
|
86-3335449 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
|
4020 Stirrup Creek Drive, Suite
110
Durham, NC |
|
27703 |
| (Address of registrant’s principal executive office) |
|
(Zip code) |
Registrant’s telephone number, including
area code: (919) 908-2400
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share |
|
PTHS |
|
The NYSE American LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01. Regulation FD Disclosure.
On September 2, 2025, Pelthos Therapeutics
Inc. (the “Company”) issued a press release announcing that its Chief Executive Officer, Scott Plesha, and Chief Financial
Officer, Francis Knuettel II, will present at the Wells Fargo 2025 Healthcare Conference in Boston, Massachusetts. Management’s
presentation will take place on Wednesday, September 3, 2025 at 1:30 p.m. Eastern Time. A webcast of the presentation will be available
on the Events and Presentations pages of the Company’s website at https://pelthos.com. Archived replays will be available
for 90 days following the conference. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
At the conference, the Company will provide
an update on its product pipeline and discuss recent business developments, including its commercial launch of ZELSUVMITM.
The presentation materials furnished herewith as Exhibit 99.2 (the “Presentation Materials”) will be used in connection
with such presentation, are incorporated into this Item 7.01 by reference and will be posted on the Company’s website at
https://pelthos.com. Information contained on the Company’s website is not incorporated by reference into and should not
be considered to be part of this Current Report on Form 8-K.
The information contained in this Item
7.01, including Exhibits 99.1 and 99.2 attached hereto, which are incorporated into this Item 7.01 by reference, is being furnished
and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly
set forth by specific reference in such filing. The information set forth in this Item 7.01 and Exhibits 99.1 and 99.2 attached
hereto shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required
to be disclosed solely to satisfy the requirements of Regulation FD.
Forward-Looking Statements
Exhibit 99.2 attached hereto contains forward-looking
statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding the Company’s current expectations.
All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances,
words such as “plans,” “believes,” “expects,” “anticipates,” and “will,”
and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance
on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only
as of the date hereof. These forward-looking statements include, without limitation, references to our expectations regarding (i)
the success of the launch for ZELSUVMI, (ii) the Company’s ability to develop its pipeline, (iii) the Company’s ability
to protect its intellectual property and to enforce its intellectual property rights, and (iv) the Company’s ability to execute
its development strategy and sustain its competitive position. These statements are not guarantees of future performance and are
subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results
to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties
related to there being no guarantee that the trading price of the combined company’s Common Stock will be indicative of the
combined company’s value or that the combined company’s Common Stock will become an attractive investment in the future;
we may rely on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue
projections and may not receive expected revenue; we and our partners may not be able to timely or successfully advance any product(s)
in our internal or partnered pipeline or receive regulatory approval and there may not be a market for the product(s) even if successfully
developed and approved; and changes in general economic conditions, including as a result of war, conflict, epidemic diseases,
the implementation of tariffs, and ongoing or future litigation could expose us to significant liabilities and have a material
adverse effect on us. These and other risks and uncertainties are described more fully in our filings with the U.S. Securities
and Exchange Commission. The information in this Current Report on Form 8-K is provided only as of the date of this Current Report
on Form 8-K, and we undertake no obligation to update any forward-looking statements contained in this Current Report on Form 8-K
based on new information, future events, or otherwise, except as required by law.
Item 9.01. Financial Statements and
Exhibits
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated September 2, 2025. |
| 99.2 |
|
Pelthos Therapeutics Inc. Q3 2025 Presentation |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| |
|
|
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 3, 2025 |
Pelthos Therapeutics Inc. |
| |
|
|
| |
By: |
/s/ Francis Knuettel II |
| |
|
Name: |
Francis Knuettel II |
| |
|
Title: |
Chief Financial Officer |
