Basilea provides portfolio update and outlook

• Zevtera is now available in the US^{[4, 5]}, already achieving important hospital formulary wins and is also now included in major hospital purchasing organizations contracts.
• Secured US reimbursement and access pathways, New Technology Add-On Payment (NTAP) designation as innovative inpatient treatment, as well as Medicaid and 340B pricing and J-code for outpatient billing programs to support affordability and patient access.
• Repeat orders from major hospitals reflecting positive clinical experience with Zevtera among early adopters.

Fosmanogepix: Advancing phase 3 program in invasive mold and yeast infections

• FORWARD-IM, a phase 3 registrational study evaluating the efficacy and safety of the broad-spectrum antifungal fosmanogepix in adult patients with invasive mold infections, was initiated in July.^[6] This phase 3 study is currently active at 15 sites, with about 40 additional sites planned to initiate during H1 2026.
• FORWARD-IM is the second phase 3 study for fosmanogepix, following the initiation of FAST-IC in September 2024, which evaluates fosmanogepix in invasive yeast infections. FAST-IC is currently active at more than 100 sites worldwide, with additional sites planned to initiate during Q1 2026, including 22 new sites in China.^[7]
• Together, the two phase 3 studies are designed to support a broad treatment label to maximize patient reach, reflecting the broad-spectrum activity of fosmanogepix across both invasive mold and yeast infections. Both studies are progressing as planned, with topline results anticipated in H1 2028, and the regulatory submission to follow shortly afterwards.

• The development of Basilea’s antifungals fosmanogepix and BAL2062 is largely supported through an OTA agreement with BARDA.^[8] In 2025, BARDA committed USD 64 million in two tranches following the successful achievement of predefined development milestones.

Ceftibuten-ledaborbactam: addressing unmet needs in cUTI

• In August, we secured global rights to ceftibuten-ledaborbactam (CTB-LEDA) through an exclusive licensing agreement with Venatorx Pharmaceuticals. CTB-LEDA is an oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination developed to treat cUTI, including certain kidney infections (acute pyelonephritis).
• In September, a prior BARDA contract was novated from Venatorx to Basilea, providing significant non-dilutive funding of up to USD 159 million to support the cUTI program.^[9] The first tranche of USD 6 million has already been committed, with additional tranches expected upon achievement of predefined development milestones.
• We are on track to initiate the phase 3 clinical program in Q1 2027, following regulatory interactions planned during 2026. Given the anticipated high patient enrollment rates, we are also focusing during 2026 on securing drug-supply, enabling efficient trial execution in 2027 and 2028 and a topline readout in early 2029.

Early-stage pipeline programs: Completed preclinical profiling and advancing toward next inflection points

• We have successfully completed the preclinical profiling of the first-in-class LptA inhibitor antibiotic BAL2420^[10] and expect to initiate a first in-human clinical study in the first half of 2026. BAL2420 is being developed to address severe infections caused by Gram-negative bacteria.
• Preclinical profiling of the antifungal BAL2062 has also been successfully completed. In 2026 we expect to conclude discussions with regulatory authorities to define the optimal phase 2 and phase 3 clinical development pathways for this drug-candidate.

New R&D partnerships: Driving long-term value creation

In December and January, we entered into two collaborations aimed at accelerating innovation and strengthening our early-stage pipeline with high-potential drug candidates to support long-term growth:

• Phare Bio partnership: This collaboration leverages cutting-edge technologies to transform antibiotic discovery by combining generative AI with Basilea’s proven expertise in anti-infectives and clinical development. Using AI to design new molecules will enable faster, more efficient development of novel antibiotics that address significant unmet medical needs.
• Prokaryotics Inc. collaboration: Focuses on developing a first-in-class, broad-spectrum antifungal drug-candidate targeting severe invasive fungal infections. This new class of antifungals will be designed to deliver effective, safe and easy-to-administer treatments, addressing significant market needs.

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:

This press release can be downloaded from www.basilea.com.

References

1. The Biomedical Advanced Research and Development Authority (BARDA) is part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services
2. Data on file, Basilea Pharmaceutica International Ltd, Allschwil
3. IQVIA Analytics Link, September 2025. In-market sales reported as moving annual total (MAT) in US dollar.
4. Full US prescribing information: https://innovivaspecialtytherapeutics.com/wp-content/uploads/2025/05/Prescribing-Information-Zevtera.pdf [Accessed: January 07, 2026]
5. Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 111 million, or approximately 75 percent of the costs related to the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities and non-clinical work
6. ClinicalTrials.gov ID NCT06925321
7. ClinicalTrials.gov ID NCT05421858
8. BARDA OTA number: 75A50124C00033
9. BARDA agreement number: 75A50123C00050
10. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by 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).

Attachment

• Press release (PDF)