Press Release: Basilea provides portfolio update and outlook

Basilea Pharmaceutica

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-- Clinical portfolio strengthened through the in-licensing of phase 3-ready

antibiotic ceftibuten-ledaborbactam

-- Fosmanogepix second phase 3 study initiated; two phase 3 studies in

invasive fungal infections progressing as planned

-- Two new preclinical collaborations to develop novel antibacterial and

antifungal drugs

-- Cresemba continued strong double-digit in-market sales growth

Allschwil, Switzerland, January 08, 2026

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today on the progress within its R&D and commercial portfolio during 2025 and outlined the upcoming milestones and timelines.

David Veitch, Chief Executive Officer, highlighted: "We entered 2025 from a position of strength and closed the year even stronger, thanks to outstanding execution and significant progress across all fronts. During 2025, we delivered on every goal we set."

He continued: "Cresemba celebrated its 10th year on the market with continued commercial success, achieving strong global in-market sales and expanding its reach to more than 75 countries. Zevtera was successfully launched in the US, its commercially most important market, while our R&D pipeline advanced toward next milestones. This included fosmanogepix entering its second phase 3 study and the in-licensing of ceftibuten-ledaborbactam, a novel oral antibiotic for complicated urinary tract infections (cUTI). These programs are designed to drive medium-term growth and are progressing fully in line with our plan."

He concluded: "Our business model is anchored in strong partnerships. Recently, we forged two new collaborations in preclinical development: one focused on artificial intelligence (AI)-driven antibacterial drug design and the other on antifungal drug development. These partnerships combine our expertise in anti-infectives with our partners' specialized capabilities to strengthen our early-stage pipeline. At the same time, existing partnerships remained robust. We secured substantial non-dilutive funding through the Other Transactions Agreement (OTA) with the Biomedical Advanced Research and Development Authority (BARDA)([) (1) (]) for our antifungals fosmanogepix and BAL2062, and a prior BARDA contract was novated to Basilea following the in-licensing of the antibiotic ceftibuten-ledaborbactam. Commercial partnerships also delivered multiple milestone payments from Europe, China/Asia-Pacific, and Japan, underscoring the success of our commercial products as they address patients' needs worldwide."

Portfolio key highlights 2025 and outlook 2026

Cresemba(R) (isavuconazole): Reinforcing position as global market leader by value

-- In April, Cresemba marked its 10-year anniversary since first commercial

launch, reaffirming its position as the global market leader by value.

-- Over the past decade, about half a million patients worldwide have been

treated with Cresemba.[2]

-- This achievement reflects the strong collaboration with our commercial

partners, now having Cresemba available in more than 75 countries.

-- According to the latest available market data, total global in-market

sales of Cresemba in the twelve-month period between October 2024 and

September 2025 amounted to USD 693 million, reflecting a 27 percent

growth year-on-year, making it the largest branded antifungal for

invasive fungal infections worldwide.[3]

Zevtera(R) (ceftobiprole): Establishing a novel treatment option for Staphylococcus aureus bacteremia (SAB) in the US

-- 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 https://www.globenewswire.com/Tracker?data=sBRZAarUoGKUmuYho1o_eHJqZZhipr_LZda8fFrj0-lsLHMuXtbghewm7auANbWU_XSz4knwJAJruyJSzY7tKg6W4Fc3zPedRXDs5pXoKlM=.

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January 08, 2026 01:15 ET (06:15 GMT)