Berdazimer sodium

Conference call scheduled for November 13, 2025 at 8:00am ET Commercial launch of ZELSUVMI, the first FDA-approved at-home molluscum contagiosum treatment, exceeded expectations and generated $7.1 million in net revenues 2,716 ZELSUVMI units prescribed by 1,169 unique prescribers in the third quarter of fiscal 2025 DURHAM, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- 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 three and nine months ended September 30, 2025, which can be found at the Financial Results section of the Company’s website at https://ir.pelthos.com/financial-info/financial-results. Third Quarter and Recent Highlights Closed the merger of Channel Therapeutics Corporation and LNHC, Inc. to create Pelthos Therapeutics and raised $50.1 million in an equity private placement to support the launch and growth of ZELSUVMI™.ZELSUVMI, the first at home FDA-approved treatment for molluscum contagiosum, a viral skin pox that largely afflicts children, was launched in July 2025, exceeded expectations and generated $7.1 million in net sales in the first quarter of commercial operations. 2,716 units of ZELSUVMI were dispensed and were written by 1,169 unique prescribers.Completed the acquisition of XEPI® in November 2025, which added a complementary dermatology product to the Pelthos portfolio anchored by ZELSUVMI. 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.Closed an $18 million private convertible notes financing in November 2025. This funding will facilitate both the purchase and relaunch of XEPI, expedite the commercial rollout of ZELSUVMI, and provide general working capital. Management Commentary Scott Plesha, CEO of Pelthos commented, “We are delighted with the commercial launch of ZELSUVMI in our first quarter as a merged company. The launch metrics, revenue growth and gross to net discounts have exceeded our expectations. We anticipate strong continued growth for ZELSUVMI in Q4 2025, as evidenced by the 2,189 units prescribed in October alone. The market uptake during the first quarter of ZELSUVMI’s launch demonstrates enthusiastic adoption by physicians and strong demand from patients and caregivers, clearly addressing a significant unmet need. Our commercial operations and newly launched marketing programs will further educate healthcare providers, parents and caregivers, as this product represents a significant shift in the treatment paradigm for molluscum contagiosum.” “In addition, the acquisition of XEPI has added a second highly complementary product to our portfolio. FDA-approved XEPI treats an infectious skin condition 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. Although it is still early days, Pelthos is well-positioned to capitalize on the large addressable markets and unmet needs presented by these two products.” Third Quarter 2025 Financial Summary (three months ended September 30, 2025) Cash position: Cash as of September 30, 2025 was $14.2 million.Net product revenue of ZELSUVMI during our first quarter of commercial operations as a merged company was $7.1 million. Cost of goods sold was $2.3 million, which includes direct and indirect costs related to the manufacture, production, packaging, and distribution of the Company’s commercial products and the stepped-up fair value of the inventory at the time of the merger. Additional details on cost of goods sold are included in the Non-GAAP Financial Information section below. Selling, general and administrative expenses were $19.6 million, consisting of personnel and non-personnel expenses to support growing sales of ZELSUVMI. Personnel-related expenses include salaries, incentive pay, benefits and share-based compensation for personnel engaged in sales, marketing, regulatory, quality, medical, non-capitalizable manufacturing, finance, information technology and administrative functions. Net loss was $16.2 million, or a net loss of $5.30 per basic and fully diluted common share. On an as converted basis, reflecting the conversion of our Series A and Series C Convertible Preferred Stock, Pelthos had a net loss of $1.83 per share. Additional details on net loss are included in the Non-GAAP Financial Information section below. Capitalization on an as converted basis, reflecting the conversion of the Series A and Series C Convertible Preferred Stock is approximately 8.9 million shares, of which, approximately 3.1 million shares of common stock are outstanding. Summary Financial Statements Pelthos Therapeutics Inc.Selected Condensed Consolidated Balance Sheet Data(unaudited)(in thousands) September 30,2025 December 31,2024Cash and cash equivalents $14,203 $513Accounts receivable, net 7,988 —Inventory, net 24,096 —Accounts payable 5,666 1,897Accrued expenses 11,890 — Total current assets $49,761 $1,369Total assets 126,433 1,369Total current liabilities 24,768 4,083Total liabilities 68,180 4,083Total stockholders' equity (deficit) 58,253 (2,714) Pelthos Therapeutics Inc.Condensed Consolidated Statements of Operations(unaudited)(in thousands except share and per share data) For the Three months EndedSeptember 30, For the Nine months EndedSeptember 30, 2025 2024 2025 2024 Revenue Net product revenues $7,112 $— $7,112 $—License and collaboration revenues 294 — 294 —Total revenue 7,406 — 7,406 —Operating expenses Cost of goods sold 2,316 — 2,316 —Selling, general and administrative 19,628 1,634 23,984 4,853Research and development 145 415 854 894Amortization of intangible assets 679 — 679 —Total operating expenses 22,768 2,049 27,833 5,747Operating loss (15,362) (2,049) (20,427) (5,747)Other (expense) income Interest expense (1,346) (39) (1,698) (678)Interest income and other income 5 393 5 396Total other (expense) income (1,341) 354 (1,693) (282)Net loss before provision for income taxes (16,703) (1,695) (22,120) (6,029)Provision for income taxes (465) — (465) —Net loss and comprehensive loss $(16,238) $(1,695) $(21,655) $(6,029) Net loss per common share - basic and diluted $(5.30) $(2.93) $(14.96) $(11.12) Weighted average number of common shares outstanding during the period - basic and diluted 3,061,488 579,229 1,447,469 542,036 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) interest expense, (iii) interest and other income, (iv) amortization of intangible assets, (v) depreciation expense, and (vi) 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: For the Three months EndedSeptember 30, For the Nine months EndedSeptember 30, 2025 2024 2025 2024Net loss and comprehensive loss $(16,238) $(1,695) $(21,655) $(6,029)Adjustments: Stock-based compensation 2,812 437 3,662 1,110Interest expense 1,346 39 1,698 678Interest and other income (5) (393) (5) (396)Amortization of intangible assets 679 — 679 —Depreciation 389 — 389 —Provision for income taxes (465) — (465) —Adjusted EBITDA $(11,482) $(1,612) $(15,697) $(4,637) 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 three and nine months ended September 30, 2025. 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: For the Three months Ended September 30, For the Nine months Ended September 30, 2025 2024 2025 2024Cost of goods sold $2,316 — $2,316 — Write-off of inventory (792) — (792) — ASC 805 Basis Step-Up (1,111) — (1,111) — Adjusted COGs $413 $— $413 $— Webcast and Conference Call Management will host a conference call today at 8:00 am ET to discuss the Company’s third fiscal quarter of 2025 results. Interested parties may participate in the call by dialing: (877) 451-6152 (Domestic)(201) 389-0879 (International)Conference ID: 13756828 The live webcast will be accessible in the Investors section of the Company’s website or by following the direct link: https://ir.pelthos.com/news-events/ir-calendar/detail/20251113-third-quarter-2025-financial-results-call (opens in new window or tab) 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 biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The company’s lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum, was approved by the U.S. Food and Drug Administration in 2024. 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 we will see continuing ZELSUVMI growth in Q4 2025; (ii) 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; (iii) our belief that Pelthos is well-positioned to capitalize on large addressable markets with ZELSUVMI and XEPI; (iv) 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 (v) 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:Mike MoyerManaging DirectorLifeSci Advisors, LLCmmoyer@lifesciadvisors.com Media:KWM CommunicationsKellie Walsh pelthos@kwmcommunications.com(914) 315-6072

Acquisition adds complementary dermatology product to the Pelthos portfolio anchored by ZELSUVMI™ 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 Private convertible notes financing will support the acquisition and re-launch of Xepi, accelerate the commercialization of ZELSUVMI for molluscum contagiosum, and for general working capital purposes Nov. 07, 2025 -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced it has acquired the U.S. commercialization rights to Xepi® (ozenoxacin) Cream, 1%, from Biofrontera Inc. and Ferrer Internacional S.A. (the “Acquisition”). Xepi is a non-fluorinated quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older. The Company has also closed on an $18 million private convertible notes financing (the “Notes”) with existing investors, including Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) and a group of investors led by Murchinson Ltd (the “Investors”). Under the terms of the Acquisition agreement, Pelthos will pay Biofrontera $3.0 million and Ferrer $1.2 million upfront, with additional payments based on the availability of commercial quantities of Xepi and the achievement of sales-based milestones. Pelthos will pay royalties on U.S. net sales of Xepi to Ferrer and the Investors. “This acquisition represents an excellent investment opportunity and marks an exciting new chapter in the Pelthos growth story,” said Scott Plesha, CEO of Pelthos. “Xepi is well-positioned to address antimicrobial resistance in pediatric dermatology, and we believe it will provide physicians with an important alternative to first-line impetigo treatments. Offering another novel product to the pediatric and dermatology communities creates an increasingly favorable opportunity for Pelthos as it allows us to leverage our current commercial infrastructure to promote multiple innovative brands.” Xepi was developed by Ferrer and Medimetriks Pharmaceuticals, Inc., and approved by the FDA in 2017. At the time of approval, Xepi was the first new novel treatment for impetigo in more than 10 years. Biofrontera has owned the U.S. rights to Xepi since 2019 but has not been actively promoting the product. Pelthos intends to re-launch Xepi in late 2026. Impetigo is a highly contagious bacterial skin infection most often caused by Staphylococcus aureus and/or Group A Streptococcus (Streptococcus pyogenes). It affects approximately 3 million people in the U.S. every year and is most common in children ages 2 to 5.1,2 Impetigo is among the most common bacterial skin infections seen in pediatric offices and spreads easily within families, in crowded settings, such as schools and childcare facilities. “As bacterial resistance continues to rise, particularly to commonly used topical antibiotics like mupirocin, the need for effective alternatives in treating impetigo has never been greater,” said Lawrence A. Schachner, MD, Chair and Professor Emeritus at the University of Miami Department of Dermatology. “Xepi is one of the few treatment options for children that can act against both methicillin-resistant and mupirocin-resistant Staphylococcus aureus. We believe it is a significant therapeutic advancement for clinicians and patients facing infections that no longer respond to traditional therapies.” Pelthos has also closed on an $18 million convertible notes financing with the Investors. The Notes will be secured obligations of Pelthos and will bear interest at a rate of 8.5% per annum, payable quarterly in arrears. The Notes will mature on November 6, 2027, unless earlier repurchased, redeemed or converted into shares of Pelthos common stock in accordance with their terms. The Notes will be convertible at an initial conversion price of $34.442, representing the price that is the lower of (i) the Official Closing Price immediately preceding the signing of the binding agreement or (ii) the average Official Closing Price for the five trading days immediately preceding the signing of the binding agreement. The Company anticipates that the proceeds of the financing will be used to acquire and relaunch Xepi, accelerate the commercialization of ZELSUVMI, and for general working capital purposes. In addition to the Notes, the Investors will be entitled to a low single-digit royalty on U.S. net sales of Xepi and additional milestone payments and royalties on ZELSUVMI net sales in Japan, if ZELSUVMI is approved in Japan. “The convertible notes transaction demonstrates the ongoing confidence of our existing investors. The additional capital from this transaction allows us to add a complementary product to our portfolio, strengthens our balance sheet, and will help support the commercial growth of ZELSUVMI, our novel medicine for molluscum contagiosum,” said Frank Knuettel II, CFO of Pelthos. Sullivan & Worcester LLP and Paul Hastings LLP served as legal counsel to Pelthos. Piper Sandler and Lake Street Capital Markets LLC served as financial advisors to Pelthos on the Notes financing, and Roth Capital Partners, LLC advised Pelthos on the Xepi acquisition. Latham & Watkins LLP served as lead counsel to Ligand. Kelley Drye & Warren LLP and Morgan, Lewis and Bockius LLP represented the group of investors led by Murchinson Ltd. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been, registered under the Securities Act or the securities laws of any other jurisdiction, and until so registered, may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer to sell, solicitation of an offer to buy or sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Pelthos Therapeutics is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The company’s lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum, was approved by the U.S. Food and Drug Administration in 2024. 1 Holly Hartman-Adams, Christine Banvard, Gregory Juckett. Am Fam Physician. 2014;90(4):229-235 2 https://health.hawaii.gov/docd/disease_listing/impetigo/ The content above comes from the network. if any infringement, please contact us to modify.