Allschwil, Switzerland, April 16, 2025 Basilea Pharmaceutica Ltd (SIX: BSLN), a biopharmaceutical company focused on addressing the urgent needs of patients battling severe bacterial and fungal infections, made a significant mark at the ESCMID Global 2025 conference. This prestigious annual meeting, organized by the European Society of Clinical Microbiology and Infectious Diseases, ran from April 11 to 15, 2025, in the cultural hub of Vienna, Austria. At the event, Basilea showcased a series of scientific presentations highlighting their clinical-stage antifungal agent, fosmanogepix, alongside discussions on the antifungal isavuconazole (Cresemba) and the antibiotic ceftobiprole (Zevtera).

Dr. Marc Engelhardt, the Chief Medical Officer of Basilea, emphasized the growing global threat posed by invasive fungal infections. He stated, Invasive fungal infections are an increasing global health problem, and novel antifungals are urgently needed. To combat this dire situation, more than 250 patients suffering from challenging invasive fungal infections have accessed fosmanogepix through expanded access programs. The results shared at ESCMID demonstrated the potential of fosmanogepix as a life-saving option, particularly for patients with invasive fusariosis and mucormycosis, who have shown significant responses to this treatment. Dr. Engelhardt expressed anticipation for the upcoming second phase 3 study of fosmanogepix, which will encompass a wide range of mold infections, including aspergillosis, fusariosis, and mucormycosis.

In total, over 250 patients from 11 countries facing serious or life-threatening invasive fungal infections have received fosmanogepix after standard antifungal treatments either failed, caused intolerable side effects, or involved resistant fungal strains. As revealed during the conference, fosmanogepix showcased impressive response rates exceeding 70% among patients suffering from invasive fusariosis or mucormycosis, with a favorable tolerance profile allowing for extended treatment durations.

Additionally, various presentations highlighted the antifungal activity of fosmanogepix, focusing on its effectiveness against a diverse range of yeast and mold species collected as part of a comprehensive global surveillance initiative.

The specific presentations regarding fosmanogepix at ESCMID Global 2025 included:

• Presentation IPT13: Fosmanogepix a novel clinical phase 3 stage antifungal agent M. Engelhardt
• Presentation O0419: Fosmanogepix expanded access in patients with Fusarium infections S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner
• Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis A. Puing, A. Kaur, Y. J. Lee, P. Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens
• Poster E0237: Activity of manogepix against a worldwide collection of mold isolates from 2023 M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira
• Poster P2891: Activity of manogepix against a worldwide collection of yeast isolates from 2023 M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira

Furthermore, presentations related to isavuconazole (Cresemba) included:

• Poster P2944: Understanding Connections between Isavuconazole Drug Exposures and Responses Among Different Infections: Mucorales L. Kovanda, A. Desai
• Poster P2945: Investigating Connections Between Isavuconazole Drug Exposures and Responses: Dimorphic Fungi/Mould/Other Filamentous Fungi A. Desai, L. Kovanda
• Poster P2946: Analyzing Isavuconazole Drug Exposures and Responses in Invasive Candidiasis L. Kovanda, A. Desai
• Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Model from Three Phase 3 Trials A. Desai, L. Kovanda
• Poster E0055: High-dose Isavuconazole therapy is well tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis

Finally, data on ceftobiprole (Zevtera) included:

• Poster E0792: Comparing Ceftobiprole Alone vs. Combination with Ampicillin Against Borderline Penicillin-Resistant, Vancomycin-Resistant Enterococcus faecalis O. Funk, I. Khan, J. Li, J. Cusumano

About Fosmanogepix
Fosmanogepix is a clinical-stage broad-spectrum antifungal agent featuring a unique mechanism of action. Its active component has demonstrated efficacy against prevalent species of Candida and Aspergillus, including multi-drug-resistant variants such as Candida auris and Candida glabrata, along with rare molds like Fusarium spp. and Scedosporium spp. This revolutionary treatment option has undergone evaluations in clinical phase 2 studies for both candidemia and invasive mold infections. Currently, a phase 3 study is in progress to assess fosmanogepix for treating adult patients with candidemia and/or invasive candidiasis. Due to its promising profile, fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for seven distinct indications and is classified as a Qualified Infectious Disease Product (QIDP).

About Cresemba (Isavuconazole)
Cresemba, containing the active ingredient isavuconazole, is an intravenous and oral azole antifungal approved in the European Union member states, as well as in countries like Iceland, Liechtenstein, and Norway. It is utilized for treating invasive aspergillosis and mucormycosis in patients unsuitable for amphotericin B. The drug has also gained approval in the United States and several other regions worldwide, including the United Kingdom, the Middle East, North Africa, Asia Pacific, China, and Japan. It holds orphan drug designation in the U.S., Europe, and Australia for its approved uses.

About Zevtera (Ceftobiprole Medocaril Sodium)
Ceftobiprole, the active compound of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic designed for intravenous administration, exhibiting rapid bactericidal effects against a variety of Gram-positive and Gram-negative bacteria. In numerous countries, it is marketed under the brand names Zevtera and Mabelio for treating hospital-acquired bacterial pneumonia (HABP) and community-acquired bacterial pneumonia (CABP). In the U.S., ZEVTERA is indicated for treating adults with Staphylococcus aureus bloodstream infections and acute bacterial skin and skin structure infections.

About Basilea
Basilea is a commercial-stage biopharmaceutical company established in 2000, headquartered in Switzerland. The company is dedicated to discovering, developing, and commercializing innovative therapeutics to tackle severe bacterial and fungal infections. It has successfully launched two hospital brands: Cresemba and Zevtera. In addition, Basilea maintains a diverse portfolio of preclinical and clinical anti-infective assets and is listed on the SIX Swiss Exchange (SIX: BSLN). For more information, visit media_relations@basilea.com, investor_relations@basilea.com

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Elena Petrova