[8-K] Pelthos Therapeutics Inc. Reports Material Event
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Pelthos Therapeutics Inc. reported its fourth-quarter and full-year 2025 results, showing a rapid commercial ramp for its lead product ZELSUVMI and expansion of its dermatology portfolio. ZELSUVMI net product revenue reached $16.2 million from launch in July 2025 through December 31, including $9.1 million in the fourth quarter, while total 2025 revenue including licensing was $16.8 million. Prescribers wrote 8,948 ZELSUVMI units in 2025 from 2,712 unique prescribers, with dispensed units rising 129% quarter over quarter. Pelthos acquired FDA‑approved XEPI for impetigo in November 2025 and XEGLYZE for head lice in January 2026, positioning a three-product pediatric-focused infectious skin franchise. To fund growth, the company closed an $18.0 million private convertible notes financing in November 2025 and entered a $50.0 million senior secured term loan in January 2026, drawing $30.0 million. Cash was $18.0 million as of December 31, 2025. Despite this progress, Pelthos reported a 2025 net loss of $43.3 million, including a $21.7 million loss in the fourth quarter, driven by high selling and administrative expenses, a non-cash $15.0 million fair value loss on convertible debt, and ongoing investments in commercialization.
Positive
- None.
Negative
- None.
Insights
Pelthos is scaling its first launch quickly but remains deeply loss-making.
Pelthos generated $16.8M of 2025 revenue, almost entirely from ZELSUVMI’s July launch, with Q4 net product revenue of $9.1M versus $7.1M in Q3. That quarter-over-quarter growth and 129% increase in units dispensed indicate early demand in molluscum contagiosum.
However, the company posted a 2025 net loss of $43.3M, including a Q4 loss of $21.7M. Q4 operating loss improved to $12.0M, but total other expense was heavily impacted by a $15.0M non-cash fair value loss on November 2025 convertible notes. Adjusted EBITDA loss for 2025 was $24.7M.
Management is leaning on debt: an $18.0M private convertible notes deal in November 2025 and a $50.0M senior secured term loan in January 2026, of which $30.0M was drawn. This supports commercialization of ZELSUVMI, XEPI and XEGLYZE but adds leverage, so future filings will clarify whether revenue growth and SG&A discipline offset interest expense and non-cash valuation swings.
Pelthos is building a focused pediatric infectious skin franchise.
The company is assembling three FDA-approved, pediatric-heavy dermatology products: ZELSUVMI for molluscum contagiosum, XEPI for impetigo and XEGLYZE for head lice. Management highlights overlapping prescriber targets and a 64‑person sales force to promote all three, aiming for operating leverage rather than separate infrastructures.
Coverage and pricing dynamics matter. Pelthos cites approximately 70% combined commercial and Medicaid coverage for ZELSUVMI by Q1 2026, with favorable gross-to-net levels, and a wholesale acquisition cost of $2,008.50. SG&A fell about 5% quarter over quarter in Q4 while revenue increased, suggesting early scale efficiencies.
Future catalysts described include a planned XEPI relaunch in late 2026 and a XEGLYZE launch in the first half of 2027. Execution risk revolves around maintaining prescription growth, fully utilizing the expanded sales team, and integrating new brands without materially increasing selling costs beyond the roughly $18.5M Q4 SG&A run rate disclosed here.
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): March 19, 2026
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (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 | ||||||||||||
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 x
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. o
Item 2.02. Results of Operations and Financial Condition.
On March 19, 2026, Pelthos Therapeutics Inc. (the “Company”) issued a press release summarizing its financial results for the three months and year ended December 31, 2025, as well as providing an update on the Company’s operations. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference.
The information in this Item 2.02 and Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, 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, except as expressly set forth by specific reference in such filing.
Item 7.01. Regulation FD Disclosure.
The information disclosed in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is incorporated into this Item 7.01 by reference.
On March 19, 2026, the Company made available a presentation on its website. A copy of the presentation is attached hereto as Exhibit 99.2. 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 Exhibit 99.2 attached hereto, which is 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 Exhibit 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, and may indicate, forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and as defined in the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company’s future activities, or future events or conditions, including without limitation, those statements relating to the success of its products and product candidates, timing, progress and results of any preclinical and clinical trials, its estimates regarding the potential market opportunity for its products and product candidates, its ability to develop its pipeline, its ability to protect its intellectual property and enforce its intellectual property rights, its ability to procure new customers and partners, and its ability to execute its development strategy and sustain its competitive position. Actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the Company’s limited operating history, its ability to establish its market development capabilities to commercialize its products and generate any revenue, its ability to secure and execute financing transactions, and its ability to maintain regulatory approval of certain of its products, which can be identified by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict, “project,” “seek,” “should,” “target,” “will,” “would” and other similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not historical facts and are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by its management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict, many of which are beyond the Company’s control. Any forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this Form 8-K, except as required by applicable law.
Item 9.01. Financial Statements and Exhibits
| (d) | Exhibits: | |||||||
| Exhibit No. | Description | |||||||
| 99.1 | Press Release, dated March 19, 2026 | |||||||
| 99.2 | Company 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: March 19, 2026 | Pelthos Therapeutics Inc. | ||||||||||
| By: | /s/ Francis Knuettel II | ||||||||||
| Name: | Francis Knuettel II | ||||||||||
| Title: | Chief Financial Officer | ||||||||||
Exhibit 99.1
Pelthos Therapeutics Announces Fourth Quarter and Full Year 2025 Financial Results
ZELSUVMI™ net product revenue grew 28% Quarter over Quarter to $9.1 million, bringing total ZELSUVMI net product revenue to $16.2 million, for the period from the launch in July 2025 through December 31, 2025. Total revenue including licensing revenue was $16.8 million for 2025.
8,948 ZELSUVMI units prescribed by 2,712 unique prescribers for fiscal year 2025, with a 129% quarter over quarter increase in units dispensed, rising from 2,716 units in the third quarter of 2025 to 6,232 units in the fourth quarter of 2025.
Management will host a conference call today at 8:00 a.m. EDT
DURHAM, N.C., March 19, 2026 — Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos” or the “Company”), today announced its financial results for the fourth quarter and full year ended December 31, 2025, which can be found at the Financial Results section of the Company’s website at https://ir.pelthos.com/financial-info/financial-results.
Recent and Full Year 2025 Highlights
•ZELSUVMI, the first at home FDA-approved treatment for molluscum contagiosum (“MC”), a highly contagious viral skin infection that largely afflicts children, was launched in July 2025 and generated $16.2 million in net sales in the first two quarters of commercial operations, exceeding expectations.
•From the launch of ZELSUVMI in July 2025 through December 31, 2025, 8,948 units of ZELSUVMI were dispensed and were written by 2,712 unique prescribers. Quarter over quarter units of ZELSUVMI dispensed rose from 2,716 in the third quarter of 2025 to 6,232 in the fourth quarter of 2025, representing a 129% increase.
•In November 2025, we completed the acquisition of XEPI®, which added a complementary dermatology product to our portfolio. XEPI is a novel FDA-approved topical treatment for impetigo that addresses a critical unmet need in antibiotic-resistant skin infections caused by staph and strep infections, most commonly affecting children. Impetigo affects approximately 3 million people in the U.S. every year and is among the most common bacterial skin infections seen in pediatric offices.
•In November 2025, we closed an $18.0 million private convertible notes financing. This financing facilitated the purchase of and work to launch XEPI, accelerate the commercial rollout of ZELSUVMI and provided us with funds for general working capital purposes.
•In January 2026, we announced the acquisition of XEGLYZE® (abametapir) from Hatchtech Pty Ltd., an Australian biotech company. XEGLYZE is a novel, patent protected prescription medication indicated for the topical treatment of head lice infestation in patients 6 months of age and older. In the U.S., infestation with head lice is most common among preschool- and
elementary-school age children and their household members and caretakers. An estimated 6 to 12 million infestations occur each year in the U.S. among children.
•In January 2026, we entered into a $50.0 million senior secured term loan facility, of which we drew $30.0 million at the close, with Horizon Technology Finance. The term loan provides us with the flexibility and resources to accelerate the commercialization of our portfolio and strengthens our balance sheet.
•Our cash balance as of December 31, 2025 was $18.0 million, which excludes the $30.0 million in term debt funding secured in January 2026, as set forth above. The cash balance is expected to support the current business plan, and the debt-based financing demonstrates the Company’s desire to be conscious of dilution and shareholder capital.
•As of December 31, 2025, we had 8.9 million shares outstanding on an as converted basis, which includes unconverted Series A and Series C Convertible Preferred Stock and approximately 3.2 million shares of common stock.
•We recently completed the previously announced expansion of the sales force, adding fourteen sales representatives in heretofore uncovered territories, bringing the nationwide total to 64 sales representatives.
Management Commentary
Scott Plesha, CEO of Pelthos commented, “We are delighted with the growth of ZELSUVMI in our second quarter of commercialization despite the seasonal reduction of patients seeking MC treatment during the fourth quarter. The launch metrics, including prescriptions, revenue growth, gross to net discounts and other financial results, have exceeded our expectations. We anticipate strong continued growth for ZELSUVMI in 2026 and with the capital raised with the issuance of the convertibles notes in November 2025 and the term debt issued in January 2026, we believe that our cash balance provides the runway to execute on our business plan.”
“In addition, the recent acquisition of XEPI and XEGLYZE have added two highly complementary products to our portfolio. FDA-approved XEPI and XEGLYZE each treat infectious skin conditions primarily impacting children, which aligns with the same target market as ZELSUVMI. This presents our sales reps and Pelthos with a synergistic opportunity to increase revenue by leveraging our current commercial relationships and infrastructure with de minimis additional SG&A. We believe we are well-positioned to capitalize on the large addressable markets and unmet needs presented by these three products and have the commercial infrastructure and experience to continue to grow ZELSUVMI and launch and grow XEPI and XEGLYZE.”
Fourth Quarter 2025 Financial Summary
•Our net product revenue for ZELSUVMI during the fourth quarter of 2025 was $9.1 million, as compared to $7.1 million in the third quarter of 2025, representing an approximate 28% increase in product revenue quarter over quarter.
•Our cost of goods sold was $1.7 million for the fourth quarter of 2025 as compared to $2.3 million in the third quarter of 2025. Excluding fair value adjustments related to finished goods and API inventory on hand at the time of the merger, as well as the write-off of API related to one out of specification API batch and previously capitalized process validation expenses, cost of goods sold was $0.1 million in the fourth quarter of 2025 and $0.4 million in the third quarter of 2025.
•Our SG&A expenses were $18.5 million for the fourth quarter of 2025, as compared to $19.6 million for the third quarter of 2025, representing a decrease in SG&A expenses of approximately 6% quarter over quarter. Excluding non-cash items, non-capitalized transaction expenses and royalty expenses, our adjusted SG&A declined from approximately $14.2 million for the third quarter of 2025 to $13.5 million for the fourth quarter of 2025, representing an approximate decline in adjusted SG&A expenses of 5% quarter over quarter.
•Our operating loss improved from a loss of approximately $15.4 million in the third quarter of 2025 to a loss of approximately $12.0 million in the fourth quarter of 2025, representing a clear step towards reaching positive cash flow and net income.
•Our adjusted EBITDA, netting out non-cash and non-capitalized transaction expenses, improved from a loss of approximately $11.5 million in the third quarter of 2025 to approximately $9.0 million in the fourth quarter of 2025, representing an improvement of approximately 22% quarter over quarter.
•Change in fair value of debt, related to the convertible note issued in November 2026, was $15.0 million in the fourth quarter of 2025. The Company analyzed the terms of the convertible notes and its embedded features concluding it appropriate to account for the convertible notes at fair value. Accordingly, the Company initially recognized the convertible notes at fair value and will subsequently measure the convertible notes at fair value with changes in fair value recorded in current period earnings.
•Income tax benefit of $6.9 million for the fourth quarter of 2025 related to the release of valuation allowance for historical deferred tax assets.
•See additional detail within the Summary Financial Statement tables and Non-GAAP Financial Information below.
Webcast and Conference Call
Management will host a conference call today at 8:00 am ET to discuss the Company’s fourth quarter and full year 2025 results. Interested parties may participate in the call by dialing:
(877) 451-6152 (Domestic)
(201) 389-0879 (International)
Conference ID: 13758894
The live webcast will be accessible in the Investors section of the Company’s website or by following the direct link:
https://viavid.webcasts.com/starthere.jsp?ei=1753536&tp_key=4e91699655
For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Pelthos’ website.
About Pelthos Therapeutics
Pelthos Therapeutics is a commercial-stage biopharmaceutical company focused on building and advancing a portfolio of differentiated cutaneous infectious disease products that address unmet patient needs. ZELSUVMI™ (berdazimer) topical gel, 10.3%, the company’s lead product, is the first and only prescription therapy approved for use at home by patients, parents, and caregivers to treat Molluscum contagiosum. The company’s portfolio of assets includes XEPI® (ozenoxacin) Cream, 1%, a topical
treatment for impetigo, and XEGLYZE® (abametapir), a topical treatment for head lice. More information is available at www.pelthos.com. Follow Pelthos on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Pelthos’ 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) our belief that our cash balance provides the runway to execute on our business plan; (ii) our belief that we will see continuing ZELSUVMI growth in 2026; (iii) the anticipated benefits of the acquisition of XEPI and that it will leverage our existing commercial and sales operations and provide additional opportunities to expand our revenue while benefiting from overhead cost synergies given XEPI’s complementary target market; (iv) our belief that Pelthos is well-positioned to capitalize on large addressable markets with ZELSUVMI, XEPI and XEGLYZE; (v) our belief that the exclusion of certain items in calculating Adjusted EBITDA and Adjusted COGs can provide a useful measure for period-to-period comparisons of our business; and (vi) our belief that Adjusted COGs provides useful information to investors in understanding and evaluating our operating results. 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 press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law.
Contacts
Investors:
LifeSci Advisors, LLC
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com
Media:
KWM Communications
Kellie Walsh
pelthos@kwmcommunications.com
(914) 315-6072
Summary Financial Statements
| Pelthos Therapeutics Inc. | |||||||||||
| Selected Condensed Consolidated Balance Sheet Data (unaudited) (in thousands) | |||||||||||
| December 31, 2025 | December 31, 2024 | ||||||||||
| Cash and cash equivalents | $ | 17,973 | $ | 513 | |||||||
| Accounts receivable, net | 8,858 | — | |||||||||
| Inventory, net | 23,574 | — | |||||||||
| Total current assets | 53,410 | 1,369 | |||||||||
| Total assets | 130,397 | 1,369 | |||||||||
| Accounts payable | $ | 2,986 | $ | 1,897 | |||||||
| Accrued expenses | 15,364 | — | |||||||||
| Total current liabilities | 25,993 | 4,083 | |||||||||
| Total liabilities | 91,516 | 4,083 | |||||||||
| Total stockholders' equity (deficit) | 38,881 | (2,714) | |||||||||
| Total liabilities and stockholders' equity (deficit) | 130,397 | 1,369 | |||||||||
| Pelthos Therapeutics Inc. | |||||||||||||||||||||||
| Condensed Consolidated Statements of Operations (unaudited) (in thousands except share and per share data) | |||||||||||||||||||||||
| Quarters Ended December 31, | Years Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Revenue | |||||||||||||||||||||||
| Net product revenues | $ | 9,094 | $ | — | $ | 16,206 | $ | — | |||||||||||||||
| License and collaboration revenues | 295 | — | 589 | — | |||||||||||||||||||
| Total revenue | 9,389 | — | 16,795 | — | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Cost of goods sold | 1,672 | — | 3,988 | — | |||||||||||||||||||
| Selling, general and administrative | 18,469 | 1,539 | 42,453 | 6,392 | |||||||||||||||||||
| Research and development | 374 | 285 | 1,228 | 1,179 | |||||||||||||||||||
| Amortization of intangible assets | 877 | — | 1,556 | — | |||||||||||||||||||
| Total operating expenses | 21,392 | 1,824 | 49,225 | 7,571 | |||||||||||||||||||
| Operating loss | (12,003) | (1,824) | (32,430) | (7,571) | |||||||||||||||||||
| Other (expense) income | |||||||||||||||||||||||
| Interest expense | (1,314) | (108) | (3,012) | (786) | |||||||||||||||||||
| Impairment of intangible assets | (285) | — | (285) | — | |||||||||||||||||||
| Change in fair value of convertible debt | (14,984) | — | (14,984) | — | |||||||||||||||||||
| Interest income and other income | — | 6 | 5 | 402 | |||||||||||||||||||
| Total other (expense) income | (16,583) | (102) | (18,276) | (384) | |||||||||||||||||||
| Net loss before provision for income taxes | (28,586) | (1,926) | (50,706) | (7,955) | |||||||||||||||||||
| Provision for income taxes | (6,922) | — | (7,387) | — | |||||||||||||||||||
| Net loss and comprehensive loss | $ | (21,664) | $ | (1,926) | $ | (43,319) | $ | (7,955) | |||||||||||||||
| Net loss per common share - basic and diluted | $ | (6.87) | $ | (3.19) | $ | (23.04) | $ | (14.27) | |||||||||||||||
| Weighted average number of common shares outstanding during the period - basic and diluted | 3,154,538 | 603,346 | 1,880,498 | 557,447 | |||||||||||||||||||
The table below sets forth the income statement for the third and fourth quarters of 2025. This table will be provided through the second quarter of 2026, after which this will be discontinued as the Company will have comparable year over year comparisons:
| Pelthos Therapeutics Inc. | |||||||||||
| Condensed Consolidated Statements of Operations (unaudited) (in thousands except share and per share data) | |||||||||||
| Quarters Ended | |||||||||||
| December 31, 2025 | September 30, 2025 | ||||||||||
| Revenue | |||||||||||
| Net product revenues | $ | 9,094 | $ | 7,112 | |||||||
| License and collaboration revenues | 295 | 294 | |||||||||
| Total revenue | 9,389 | 7,406 | |||||||||
| Operating expenses | |||||||||||
| Cost of goods sold | 1,672 | 2,316 | |||||||||
| Selling, general and administrative | 18,469 | 19,628 | |||||||||
| Research and development | 374 | 145 | |||||||||
| Amortization of intangible assets | 877 | 679 | |||||||||
| Total operating expenses | 21,392 | 22,768 | |||||||||
| Operating loss | (12,003) | (15,362) | |||||||||
| Other (expense) income | |||||||||||
| Interest expense | (1,314) | (1,346) | |||||||||
| Impairment of intangible assets | (285) | — | |||||||||
| Change in fair value of convertible debt | (14,984) | — | |||||||||
| Interest income and other income | — | 5 | |||||||||
| Total other (expense) income | (16,583) | (1,341) | |||||||||
| Net loss before provision for income taxes | (28,586) | (16,703) | |||||||||
| Provision for income taxes | (6,922) | (465) | |||||||||
| Net loss and comprehensive loss | $ | (21,664) | $ | (16,238) | |||||||
| Net loss per common share - basic and diluted | $ | (6.87) | $ | (5.30) | |||||||
| Weighted average number of common shares outstanding during the period - basic and diluted | 3,154,538 | 3,061,488 | |||||||||
Non-GAAP Financial Information
Adjusted EBITDA
To provide investors with additional information regarding the Company’s financial results, we have provided within this press release Adjusted EBITDA, a non-GAAP financial measure. We define Adjusted EBITDA as net loss adjusted to eliminate (i) stock-based compensation expense, (ii) intangible asset impairment, (iii) change in fair value of convertible debt;(iv) interest expense, (v) interest and other income, (vi) amortization of intangible assets, (vii) depreciation expense, and (viii) the provision for income taxes. We have provided a reconciliation below of Net Loss and Comprehensive Loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA.
We have included Adjusted EBITDA in this press release because it is a key measure used by our management to understand and evaluate our core operating performance and trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe
the exclusion of certain items from net loss in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our business.
Accordingly, we believe that Adjusted EBITDA provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP
The following table presents a reconciliation of Net Loss and Comprehensive Loss to Adjusted EBITDA for each of the periods indicated (in thousands):
| Quarters Ended December 31, | Years Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net loss and comprehensive loss | $ | (21,664) | $ | (1,926) | $ | (43,319) | $ | (7,955) | |||||||||||||||
| Adjustments: | |||||||||||||||||||||||
| Stock-based compensation | 1,799 | 450 | 5,461 | 1,560 | |||||||||||||||||||
| Impairment of intangible asset | 285 | — | 285 | — | |||||||||||||||||||
| Change in fair value of convertible debt | 14,984 | — | 14,984 | — | |||||||||||||||||||
| Interest expense | 1,314 | 108 | 3,012 | 786 | |||||||||||||||||||
| Interest and other income | — | (6) | (5) | (402) | |||||||||||||||||||
| Amortization of intangible assets | 877 | — | 1,556 | — | |||||||||||||||||||
| Depreciation | 340 | — | 729 | — | |||||||||||||||||||
| Provision for income taxes | (6,922) | — | (7,387) | — | |||||||||||||||||||
| Adjusted EBITDA | $ | (8,987) | $ | (1,374) | $ | (24,684) | $ | (6,011) | |||||||||||||||
Adjusted Cost of Goods Sold (“COGs”)
To provide investors with additional information regarding the Company’s financial results, we have provided within this press release Adjusted COGs, a non-GAAP financial measure. We define Adjusted COGs as Cost of Goods Sold adjusted to eliminate (i) expense related to inventory write down as a result of excess, obsolescence or scrap, and (ii) the inventory valuation step-up recognized in connection with the July 1, 2025 acquisition of LNHC Inc. We have provided a reconciliation below of Cost of Goods Sold, the most directly comparable GAAP financial measure, to Adjusted COGs.
We have included Adjusted COGs in this press release because it is a key measure used by our management to understand and evaluate our core operating performance and trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe the exclusion of certain items from Cost of Goods Sold in calculating Adjusted COGs can provide a useful measure for period-to-period comparisons of our business.
The Company accounts for business acquisitions using the acquisition method of accounting in accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations. ASC 805 requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values, as determined in accordance with ASC 820, Fair Value Measurements (“ASC 820”), as of the acquisition date. As part of the July 1, 2025 acquisition of LNHC, Inc., the fair value of the inventory acquired was estimated using the top/down method that considers the estimated selling price, costs to complete, disposal costs, profit margin on disposal effort, and holding costs. Significant assumptions include management’s estimates for the selling price and the costs to be incurred related to the disposal effort of the inventory. The non-cash inventory valuation step-up from the acquisition of LNHC Inc. was recognized as an adjustment to Cost of Goods Sold in the periods presented.
Accordingly, we believe that Adjusted COGs provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted COGs has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP.
The following table presents a reconciliation of Cost of Goods Sold to Adjusted COGs for each of the periods indicated (in thousands):
| Quarters Ended December 31, | Years Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Cost of goods sold | $ | 1,672 | $ | — | $ | 3,988 | $ | — | |||||||||||||||
| Adjustments: | |||||||||||||||||||||||
| Write-off of inventory | (121) | — | (1,055) | — | |||||||||||||||||||
| ASC 805 Basis Step-Up | (1,433) | — | (2,502) | — | |||||||||||||||||||
| Adjusted COGs | $ | 118 | $ | — | $ | 431 | $ | — | |||||||||||||||
1 Corporate Presentation M A R C H 2 0 2 6 Exhibit 99.2
2 Legal Disclaimer This presentation of Pelthos Therapeutics Inc. (“we”, “us”, “our” or the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict, “project,” “seek,” “should,” “target,” “will,” “would” or similar expressions and the negatives of those term are intended to identify forward-looking statements. Forward-looking statements reflect management’s current expectations, are based on judgments and assumptions, are inherently uncertain and are subject to risks, uncertainties and other factors, which could cause the Company’s actual results, performance or achievements to differ materially from expected future results, performance or achievements expressed or implied in those forward-looking statements. Examples of these forward-looking statements and the related risks, uncertainties and other factors include, but are not limited to, the following: the success of the launch of the products in our portfolio, timing, progress and results of any preclinical and clinical trials, its estimates regarding the potential market opportunity for our products, its ability to develop its pipeline, its ability to protect its intellectual property and enforce its intellectual property rights, and its ability to execute its development strategy and sustain its competitive position. Actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the Company’s limited operating history, the Company’s ability to establish its market development capabilities to commercialize its products and generate any revenue, and the Company’s ability to maintain regulatory approvals of products in our portfolio. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Any forward-looking statement in this presentation, in any related presentation supplement and in any related free writing presentation reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our business, results of operations, industry and future growth. You should read this presentation with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
33 • Large addressable market with $2,008.50 wholesale acquisition cost (”WAC”) • Launched July 2025 • Modest acquisition cost, unencumbered future revenue stream • Expected launch in late 2026 • 6–12 million U.S. cases annually • Expected launch during the first half of 2027 Investment Highlight Commercial biopharmaceutical company focused on growing, differentiated cutaneous infections product portfolio Highly synergistic Xepi and Xeglyze product acquisitions leverage Zelsuvmi’s current commercial and market access team and infrastructure Strong potential revenue streams with very attractive gross to nets Disciplined, accretive, cost-efficient product acquisition model and experienced management team to manage execution Product Portfolio
4 Corporate Profile Key Data Points (as of 03/16/26, except where noted) Ticker PTHS Stock Price $24.00 O/S Shares of Common Stock (on an as converted basis) 8.9M Market CAP ~$215M Avg. Daily Trading Volume 11,900 shares (Yahoo) Cash at end of 2025 $18.0M (not including $30.0M in term notes issued in Jan. 2026 Investment to date >$400M Pelthos is a competitive drug portfolio company — committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet dermatological treatment burdens Zelsuvmi: Launched in July 2025. • First and only at home treatment addressing Molluscum contagiosum (“MC”), a large, underserved market treating contagious viral disease Recent portfolio acquisitions: Two FDA-approved complimentary dermatological acquisitions, will leverage Zelsuvmi commercial infrastructure buildout • Xepi (ozenoxacin) Cream 1% - novel topical treatment for impetigo • First line impetigo treatment addresses antimicrobial resistance in pediatric dermatology, drug relaunch expected in late 2026 • Xeglyze (abametapir) Lotion 0.74% - novel topical treatment for head lice • Commercial launch expected in 2027 Experienced management team: Over 20 successful prior drug launches, including Cosentyx, Otezla, Ohtuvayre, Xifaxan Current peak Net Revenue forecast of $175M per annum based on Zelsuvmi alone by 2028
5 Management Team Frank Knuettel | Chief Financial Officer Sai Rangarao | Chief Commercial Officer Scott Plesha | Chief Executive Officer • 30 years of management experience in growing early-stage companies • Raised more than $400 million via venture, public equity and debt offerings and managed more than 15 mergers and acquisition transactions along with large-scale licensing transactions with fortune 50 companies • Holds numerous board positions, at both public and private companies, including Etheros Pharmaceuticals • Earned an MBA from The Wharton School and a BA from Tufts University • >30 years of experience in the pharmaceutical industry, including two decades building and leading specialty pharma commercial efforts • President and Chief Commercial Officer at BDSI until it was acquired by Collegium Pharmaceutical in 2022 • Grew BDSI sales from $5 million to $160 million • Previously served as Senior Vice President of Gastrointestinal Sales at Salix Pharmaceuticals. During fifteen-year tenure at Salix, led nationwide salesforce that grew product sales to more than $1.5 billion annually • Earned a BA in Pre-Medicine and Pre-Medical Studies at DePauw University and pursued graduate studies in Dentistry at Indiana University Dental School • >18 years of experience leading, launching, and marketing pharmaceutical products • VP of Marketing & Head of Neurology Sales at Collegium Pharmaceutical • VP of Marketing & Commercial Operations at BDSI, until it was acquired by Collegium in 2022 • Head of US Dermatology Marketing for Otezla at Celgene leading to acquisition by Amgen for $13 Billion • Member of the commercial and marketing organization at Novartis Pharmaceuticals that launched COSENTYX® in the U.S • Earned an MS in Bioscience Regulatory Affairs from The Johns Hopkins University, an MBA and MS from the New Jersey Institute of Technology, and a BS in Computer Science from Indiana University of Pennsylvania
Molluscum & Zelsuvmi Overview
7 Molluscum Contagiosum A highly infectious viral condition primarily affecting children 1 year of age or older There are four known types of MC virus (MCV1, 2, 3, 4) with MCV1 being the most common1 Molluscum Contagiosum is caused by a pox virus and is characterized by small, round, firm, umbilicated, often painless bumps. Even after healing, re- infection is possible if in contact with an infected person or object4. ~17 million people infected in the U.S. MC can take up to five years to resolve without treatment2 Peak incidence between 1-10 years of age. Up to 73% of children go untreated3 Point prevalence of 3-6 million children (ages 0-16) in the U.S. Infection, Persistence, and Spread Visible and Psychological ImpactsPain & Skin Irritation Auto- inoculation2 Highly contagious to others ↑ risk of secondary bacterial infections2 Potential worsening of atopic dermatitis Itching, redness Inflammation Anxiety Social withdrawal Untreated Molluscum Contagiosum Has Severe Effects 1) Hebert AA, Bhatia N, Del Rosso JQ. Molluscum Contagiosum: Epidemiology, Considerations, Treatment Options, and Therapeutic Gaps. J Clin Aesthet Dermatol. 2023 Aug;16(8 Suppl 2):S4-S11. PMID: 37636018; PMCID: PMC10453394. 2.)Ludmann P. American Academy of Dermatology. Molluscum contagiosum. 4 October 2023. 3) Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol. 2015;32(3):353-357. doi:10.1111/pde.12504. 4) Schaffer JV, Berger EM. Molluscum Contagiosum. JAMA Dermatol. 2016;152(9):1072. doi:10.1001/jamadermatol.2016.2367. 5) CDC. Clinical Overview of Molluscum Contagiosum. Jan 2025
8 Zelsuvmi Has the Potential to Shift MC Treatment Paradigm Previous Treatment Options • Painful, destructive treatments3 • Attractive safety profile demonstrated in clinical trials with no / minimal scarring5,6 • Remaining treatment options such as off-label drugs / natural remedies have unproven efficacy4 • Demonstrated, proven efficacy across key primary and secondary endpoints in clinical trials6 • Necessitates travel to HCP offices, adding to the time burden for MC patients and caregivers2 • First FDA approved medication for molluscum that can be applied at home by patients or caregivers5 • Other available topical treatment requires in-office visits every 3 weeks2 • Daily application that can be started immediately 1.)Least-squares mean count reduction. See Figure 9: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful Therapeutic Intervention for Molluscum Contagiosum. Abstract and poster presented at Fall Clinical 2024. Las Vegas, NV. October 24-27, 2024. 2.) Eichenfield LF, Kwong P, Gonzalez ME, et al. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021;14(10):42-47. 3.) Hebert AA, Bhatia N, Del Rosso JQ. Molluscum Contagiosum: Epidemiology, Considerations, Treatment Options, and Therapeutic Gaps. J Clin Aesthet Dermatol. 2023;16(8 Suppl 1):S4-S11. 4.) Ong SK, Hoft I, Siegfried E. Analysis of over-the-counter products marketed to treat molluscum contagiosum. Pediatr Dermatol. 2021;38(5):1400-1403. doi:10.1111/pde.14776. 5.) Zelsuvmi Package Insert. 6.) Sugarman JL, Hebert A, Browning JC, et al. Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol. 2024;90(2):299-308. doi:10.1016/j.jaad.2023.09.066Ong The 1st & Only At Home Prescription Treatment
9 InterventionPopulation Key Study Highlights B-SIMPLE4 Primary OutcomeB-SIMPLE4 Study Locations 1) p-value <0.0001, favoring Zelsuvmi .. Source: Sugarman JL, Hebert A, Browning JC, Paller AS, Stripling S, Green LJ, Cartwright M, Enloe C, Wells N, Maeda-Chubachi T. Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol. 2023 Oct 5:S0190-9622(23)02890-6. doi: 10.1016/j.jaad.2023.09.066.Epub ahead of print. PMID: 37804936. Zelsuvmi Efficacy Shown in Phase 3 Clinical Trials Drives Commercial Launch 808 Males, 790 Females Immunocompetent children and adults aged ≥6 months with 3-70 raised MC lesions Mean age: 6.7 years (Range: 0.9 – 76.6 years) 1,598 participants randomized 917 - Zelsuvmi Topical, once-daily application of Zelsuvmi (berdazimer gel, 10.3%) to all active MC lesions for up to 12 weeks 681 - Vehicle Topical, once-daily application of vehicle control gel to all active MC lesions for up to 12 weeks Patients who applied Zelsuvmi for 12 weeks achieved a mean and median reduction in lesion count of 58% and 82%, respectively, compared to 36% and 43% for patients who applied a vehicle control gel Mean Lesion Count Reduction(1) 58.1% 35.7% Zelsuvmi Control 55 Clinics across the US 32.4% of patients treated with Zelsuvmi achieved complete clearance of MC lesions at week 12, compared to 19.7% of patients treated with vehicle control gel in the BSIMPLE-4 pivotal Phase 3 trial Median Lesion Count Reduction(1) 82.4% 42.6% Zelsuvmi Control Safety • Application site reactions were the most common adverse reaction associated with Zelsuvmi • Common application site reactions included mild pain and mild erythema (caused by increased blood flow) • Minimal scarring incidences witnessed
10CONFIDENTIAL Baseline Week 2 Week 4 0.0% -1.1 % -43.5% Week 8 -35.7% Week 12 -59.4% -82.4% -42.6% -10.7% - 25 .1% -9.0% -21 .6% - 58 .1% Baseline Week 2 Week 4 0.0% 0.0% -9.5% -10.0% -28.6% -27.8% Week 8 Week 12 Phase 3 Trial Results 1) Figure 9: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful Therapeutic Intervention for Molluscum Contagiosum. Abstract and poster presentedatFall Clinical 2024. Las Vegas, NV. October 24-27, 2024. 2) Figure 10: Browning JC, Hebert A, Enloe C, Cartwright M, Maeda-Chubachi T. Berdazimer Gel 10.3% is a Clinically Meaningful TherapeuticIntervention for Molluscum Contagiosum. Abstract and poster presented at Fall Clinical 2024. Las Vegas, NV. October 24-27, 2024. Least Squares Mean Lesion Reduction(1) P<0.0001 at all time points, favoring Zelsuvmi Median Lesion Reduction TM (2) Zelsuvmi (n= 917) Vehicle (n= 681) Zelsuvmi showed statistically significant benefit vs. vehicle after 2 weeks of therapy and through out the entire 12-week length of the Phase 3 studies Zelsuvmi (n= 917) Vehicle (n= 681)
Zelsuvmi Commercial Overview
1212 Data Source: Symphony Health- Metys Data Strong Quarter over Quarter Growth during Zelsuvmi Launch Total of 2,712 Unique Prescribers in Q3 & Q4 2025 2,716 6,232 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 Q3-2025 Q4-2025 Zelsuvmi TRx Units 1,169 2,174 0 500 1000 1500 2000 2500 Q3-2025 Q4-2025 Zelsuvmi Prescriber Count Total of 8,948 Prescribed Units in Q3 & Q4 2025 129% Increase
1313 Zelsuvmi Covered Lives by Quarter* 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Commercial Medicaid Q3 2025 Q4 2025 Q1 2026 (Feb) 99% 59% • Selective contracting strategy • 70% combined Medicaid/commercial coverage with 1 contract • Favorable Gross to Nets • Favorable approval rates with all payers *Clarivate (DRG) Fingertip Formulary • Commercial, Cash and Assistance Programs - 74% of TRxs • Managed and FSS Medicaid - 26% • Medicare <1% of TRxs
1414 Sales Team Expansion Complete Fully built out commercial team: • 64 Sales Territories Expansion completed & onboarded ~53% of MC Claims • Expanded territories include sizable markets: Seattle, Las Vegas, San Francisco, Salt Lake, etc. • Sales Team targeting: Pediatric/Adult Dermatologists, General Pediatrics, Nurse Practitioners & Physicians Assistants • Territory managers supported by Sales Training, Marketing, Commercial Operations & Market Access teams
15 Robust Zelsuvmi Tactical Execution Digital Marketing National & Regional Conference Presence YouTube Promotional Commercial Live & Virtual Educational Speaker Development New Patient Testimonials & Information ZELSUVMI GO Patient Support Program
Xepi: New Product Acquisition
17 Xepi (ozenoxacin) Cream for the treatment of Impetigo Sources: CDC Website, Xepi Pack Insert, FDA.gov • Ozenoxacin cream 1% developed as first line treatment in patients aged 2 months and older • 15 clinical studies in Phase 1 & 2 conducted • Two Pivotal Phase 3 studies conducted in both adult & pediatric patients with impetigo 2 months old and up • Ozenoxacin demonstrated superior clinical and bacteriological outcomes vs. vehicle control Xepi Clinical Story • #1 bacterial infection seen in pediatrician offices, represents 1- 2% of all visits to Pediatricians in the US, with 135M children suffering worldwide • Impetigo is a highly contagious bacterial skin infection, most often caused by Staphylococcus aureus and/or Group A Streptococcus (Streptococcus pyogenes) • Mupirocin resistance is growing significantly in the US Impetigo Facts1 • Strong synergy with existing commercial infrastructure for Zelsuvmi • Significant overlap between Xepi & Zelsuvmi HCP call points • Promotional alignment across Sales, Marketing & Commercial Operations • Anticipated Commercial Launch: Late 2026 Pelthos Opportunity Acquired from BioFrontera in October 2025 FDA Approved in 2017 Exclusivity until 2032 1https://www.cdc.gov/group-a-strep/about/impetigo.html
Xeglyze: New Product Acquisition
19 Xeglyze (abametapir) Lotion for the Treatment of Head Lice Sources: CDC Website, Xepi Pack Insert, FDA.gov • Abametapir lotion 0.74% developed as first line treatment in patients aged 6 months of age and older • Phase 2b study completed in 2014 demonstrated 100% ovicidal efficacy • Two Pivotal Phase 3 studies demonstrated that a single, ten- minute application of Xeglyze® results in a statistically significant increase in the proportion of subjects who are cleared of lice versus vehicle. Xeglyze Clinical Story • 100m+ infestations globally, with 6-12m cases in the US, each year with substantial social cost • Increasing resistance to current products containing pyrethrin, permethrin & malathion • Existing products are only effective against lice and not eggs, and most require repeat treatments to break life cycle of infestation, leading to poor compliance and reduced efficacy Head Lice Facts1 • Strong synergy with existing commercial infrastructure for Zelsuvmi and Xepi • Significant overlap between Xeglyze & Zelsuvmi HCP call points • Promotional alignment across Sales, Marketing & Commercial Operations • Anticipated Commercial Launch: First half 2027 Pelthos Opportunity Acquired from Hatchtech in December 2025 FDA Approved in 2020 Exclusivity until 2034 1https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208945lbl.pdf
Summary Financial Statements
2121 Summary Balance Sheet • Cash balance does not include $30 million raised in January 2026 with issuance of 5-year term notes; additional $20 million available on hitting certain milestones • Strong stockholder equity position and cash balance provide resources to execute on our business plan • Active $200 million shelf registration statement Notes
2222 Summary Income Statement • Revenue increased 28% quarter over quarter • SG&A expenses declined 5% quarter over quarter and operating loss improved • Adjusted EBITDA loss – removing non-cash, royalties and one-time items – improved 22% quarter over quarter • Expect personnel expenses to rise approximately $1 million per quarter in 2026 with expanded sales team and minor headcount additions for Xepi and Xeglyze launches Notes
Appendix
24 Nitricil Platform Pipeline* Asset Description Asset Description Approximate Time to NDA Filing Market Potential SB414 (AD/Psoriasis) Berdazimer topical cream, dose TBD, for treatment of mild to moderate atopic dermatitis. Phase 1/2 Clinical stage. 7.5 years $$$ (AD) $$ (Psoriasis) SB208 (Tinea Pedis -> Onychomycosis) Low alcohol berdazimer topical gel for treatment of athlete’s foot with label expansion for onychomycosis following initial approval. Phase 2/3 Clinical stage. 5 years (T. Pedis) 6.5 years (Onychomycosis) $$$$$ SB208 (Tinea Pedis + Onychomycosis) Low alcohol berdazimer topical gel for treatment of both athlete’s foot and onychomycosis. Phase 2/3 Clinical stage. 6.5 years $$$$$ SB207 (EGW/PAW) Berdazimer topical gel, 10.3% for treatment of external genital and perianal warts. Same active gel (Tube A) as Zelsuvmi but different hydrogel (Tube B) formulation. Phase 3 clinical stage. 6.5 years $ *Pelthos has contractual rights to SB207 and would need to enter into a separate license for other indications set forth herein
25 NaV1.7 Pipeline Product/ Indication Asset Description Approximate Time to NDA Filing Market Potential CT2000 Eye Drops Chronic Ocular Pain CC8464 1%, 1.25% and 1.5% ophthalmic solution Phase 1-2a ready 3-4 years $8 billion globally CT2000 Eye Drops Acute Ocular Pain CC8464 1%, 1.25% and 1.5% ophthalmic solution Phase 1-2a ready 2-3 years $400 million globally CT3000 depot Nerve Blocks CC8464 5% and 10% depot injectable Preclinical Stage 5+ years $300-570 million globally CC8464 Oral Erythromelalgia CC8464 melt-granulation capsules 50mg, 100mg, 400mg Phase 2 Ready 5+ years $2.4 billion globally CC8464 Oral Small Fibre Neuropathy CC8464 melt-granulation capsules 50mg, 100mg, 400mg Phase 2 Ready 5+ years $50 million – 100 million CC8464 Oral Acute Pain CC8464 melt-granulation capsules 50mg, 100mg, 400mg Phase 2 Ready 5+ years $20 billion globally
26 Board of Directors Peter Greenleaf, Chairman Richard Baxter Ezra Friedberg Todd Davis Richard Malamut , MD Matt Pauls Scott Plesha Andrew Einhorn
27 Operating Leverage All three products utilize the same sales team, with largely overlapping call points, provides greater operating and financial leverage with very little dedicated overhead Portfolio of FDA Approved Products Differentiated portfolio of novel, cutaneous infectious disease products, including Zelsuvmi, Xepi and Xeglyze for the treatment of MC, impetigo and head lice, respectively Barriers to Entry Strong patent portfolio, along with complex, proprietary manufacturing process for Zelsuvmi and complex, multi-step manufacturing process for Xepi provides hefty market protection Significant Unmet Need and Large Market Opportunities Each Pelthos product is differentiated from existing treatment options with considerable market opportunities Strong Financial Position Current balance sheet, revenue growth and strong existing investor support with substantial investable cash provides robust foundation for growth Pipeline Opportunity to exploit legacy Channel clinical programs and work with Ligand to execute on clinical stage programs based on the same Nitricil platform as Zelsuvmi Biopharmaceutical Platform Poised for Growth Strategically positioned to explore and integrate synergistic acquisitions, serving as a platform for investors seeking a strong foothold in the specialty biopharmaceutical market Key Highlights
28 Thank You C o n t a c t s I n v e s t o r I n q u i r i e s : M i k e M o y e r L i f e S c i A d v i s o r s , L L C M a n a g i n g D i r e c t o r m m o y e r @ l i f e s c i a d v i s o r s . c o m M e d i a : K W M C o m m u n i c a t i o n s K e l l i e W a l s h / R a c h e l K e s s l e r p e l t h o s @ k w m c o m m u n i c a t i o n s . c o m ( 9 1 4 ) 3 1 5 - 6 0 7 2
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Biotechnology
Biological Products, (no Diagnostic Substances)
United States
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