Cefixime

Additional funding awarded following successful drug candidate nominationUSD 7.3 million to support progression of antibiotic BAL2420 (LptA inhibitor) towards first-in-human clinical studies Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, December 23, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it was awarded an additional USD 7.3 million from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting the early development of antibacterial products. The new funding supports the progression of Basilea’s novel antibiotic candidate BAL2420 (LptA inhibitor) towards the start of first-in-human clinical studies, which is expected mid-2026. Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: "We are very pleased by CARB-X’s continued support for the development of this promising first-in-class drug candidate. LptA inhibitors have the potential to address an unmet medical need in the hospital-based treatment of severe infections, caused by Gram-negative bacteria. We look forward to working with CARB-X to bring BAL2420 to patients." BAL2420 belongs to one of the very few novel classes of antibiotics in development. It is targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. LptA inhibitors have shown potent and rapid bactericidal activity in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy.1 Enterobacteriaceae have been highlighted by the World Health Organization (WHO) as priority pathogens, against which new antibiotics are urgently needed.2 Basilea has acquired the LptA antibiotics program from Spexis AG in early 2024. In April this year, Basilea announced that it was awarded an initial CARB-X grant of up to USD 0.9 million to support early preclinical activities. The successful completion of these activities resulted in the nomination of BAL2420 as a drug candidate and also led to a final milestone payment from Basilea to Spexis. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. About CARB-X CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerlandPhone+41 61 606 1102E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement release can be downloaded from www.basilea.com. References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: December 22, 2024) Attachment Press release (PDF)