Ozenoxacin

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 childrenImpetigo affects approximately 3 million people in the U.S. every year and is among the most common bacterial skin infections seen in pediatric officesPrivate 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 DURHAM, N.C., Nov. 07, 2025 (GLOBE NEWSWIRE) -- 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”). Xepi AcquisitionUnder 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.” Private Convertible Notes Financing 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. 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 StatementsThis 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 Xepi is well-positioned to address antimicrobial resistance in pediatric dermatology and will provide physicians with an important alternative to first-line impetigo treatments, (ii) our belief that offering Xepi to the pediatric and dermatology communities is favorable to us because it allows us to leverage our current commercial infrastructure to promote multiple innovative brands, (iii) our belief that Xepi is a significant therapeutic advancement for clinicians and patients facing infections that no longer respond to traditional therapies, (iv) the Company’s anticipated use of proceeds from the Convertible Notes financing, (v) our belief that the additional capital from the Convertible Notes transaction will allow us to add a complementary product to our portfolio, strengthens our balance sheet, and will help support the commercial growth of ZELSUVMI, and (vii) the Company’s future opportunities, strategy and plans in the market. 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 1 Holly Hartman-Adams, Christine Banvard, Gregory Juckett. Am Fam Physician. 2014;90(4):229-2352 https://health.hawaii.gov/docd/disease_listing/impetigo/

药智数据显示，2025年上半年共有1678个品种（以药品+集团+注册类型+年份除重统计）通过/视同通过一致性评价，占2024全年的54.57%，涉及659家集团企业，其中以一致性评价补充申请过评的品种较2024年大幅减少，仅占2024年的31.72%。值得一提的是，虽然齐鲁制药上半年过评品种数仅16个，排2025H1企业过评品种数第7位，但其2017年—2025年上半年的企业过评总品种数仍居首位，共206个品种过评，斩获桂冠。01过评1.整体过评情况自2021年起，以一致性评价补充申请过评的品种数增速放缓，以新注册分类仿制药申报上市的品种数有明显提升。2025H1，共有659家集团企业的1678个品种通过/视同通过一致性评价，占2024全年的54.57%。其中以3类仿制药申报上市的品种增长最多，占2024全年的80.24%，以一致性评价补充申请过评的品种数减少，仅占2024全年的31.72%。93个首家过评药品中，有43个独家企业生产，其中以3类上市的33个，4类5个，5.2类2个品种，以及3个已上市药品一致性评价过评品种（附详细名单）。齐鲁制药和人福医药，各有3个3类首仿药品上市。2025H1，通过/视同通过品种数（以药品+集团+注册类型+年份除重统计）已达到2024全年的54.57%。各申报类型中，3类仿制药上市的有601个品种（占2024全年的80.24%）；4类仿制药上市的有826个（占52.24%）；按5.2类进口仿制药品上市有34个（占55.74%）；而通过一致性评价补充申请过评的品种有217个（占31.72%）。图1 2017年-2025上半年，一致性评价过评趋势注：以药品+集团+注册类型+年份除重后统计过评品种数2.2025H1独家过评药品上半年，共有93个非集采品种首次通过/视同通过一致性评价（不包含通过一致性评价前，已有企业以新注册分类仿制药上市的品种），涉及73家企业，其中13家企业有多品种首家过评。其中以人福医药集团股份公司和齐鲁制药集团有限公司首家过评品种数最多，各有5个品种过评。图2 独家过评药品的企业排行注：以规范后药品+集团进行除重后统计3.企业过评品种数从企业过评品种数而言，2025H1共有697个药品通过/视同通过一致性评价，涉及659家集团企业。以科伦药业过评品种数最多，其次为上海复星医药，石家庄四药排第三。图3 2025H1企业过评品种数注：以规范后药品+集团进行除重后统计在企业过评总品种数方面，目前共有1460个品种（以药品统计）通过/视同通过一致性评价，涉及1399家集团企业。虽然齐鲁制药上半年过评品种数仅16个，排2025H1企业过评品种数第7位，但其2017年—2025年上半年的企业过评总品种数仍居首位，共206个品种过评。近2年，齐鲁制药和扬子江药业仿制药过评品种数逐渐减少，但科伦制药仍未放松，2025H1再发力，有37个品种过评，企业过评品种数近200，直逼齐鲁，企业过评品种数排第二位。图4 2017-2025H1企业过评品种数注：以规范后药品+集团进行除重后统计4.品种过评企业数情况从品种过评企业数而言，二羟丙茶碱注射液成为过评企业数最多的品种（22家企业），其次为法莫替丁注射液（19家），排第三的是注射用头孢唑肟钠（18家）。2024年过评企业数最多的他达拉非片25年新增12家企业过评。图5 2025H1品种过评企业数注：以规范后药品+集团进行除重后统计在总的品种过评企业数方面，仍以他达拉非片过评企业数最多（73家集团企业），其次是苯磺酸氨氯地平片（62家），排第三的是利伐沙班片（52家）。图6 2017-2025H1品种过评企业数注：以规范后药品名称+集团企业进行除重后统计5.集采情况2025H1年过评的697个药品中，主要集中在非集采药品（占64.42%），集采品种占比大幅减少。集采药品中，以系统用抗感染药最多，有54个药品，占21.77%；非集采品种中，以消化道及代谢用药最多，有64个过评。图7 2025H1过评药品集采情况注：以规范后药品除重后统计图8 集采品种ATC分类情况注：以规范后药品除重后统计图9 非集采品种ATC分类情况注：以规范后药品除重后统计02仿制药上市1.一致性申报整体情况2025年一致性评价补充申请药品数量较2024年同期有明显减少，而以新注册分类仿制药申请上市的药品数量每月较2024年均有所增加。图10 2024年仿制药申报情况备注：按药品除重统计2. 3类仿制药独家申请上半年，共有426家企业的369个药品以仿制药3类申报上市，独家申报的有28个药品，其中包括18个药品申报上市。申请临床的9个药品中，目前已有4个药品被批准，分别为贝派度酸依折麦布片、奥泽沙星洗剂、注射用醋酸亮丙瑞林混悬液、溴莫尼定凝胶。表1 2025H1，首家过评且独家生产药品信息数据来源：药智数据企业版——仿制药一致性评价分析系统声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信） 阅读原文，是受欢迎的文章哦