Curatis: Double-digit growth in core business and development milestone achieved for C-PTBE-01

Ad hoc announcement pursuant to Art. 53 LR

Liestal, Switzerland, 15 September 2025: Curatis Holding AG (SIX:CURN) reports revenues of CHF 5.2m for H1 2025, a like for like yoy growth of 14% vs 6 months of revenues of Curatis AG in 2024. In addition, Curatis was able to sign a significant partnership with Phoenix Labs, Ireland, adding 4 products that generated approximately CHF 5m of revenues in 2024. The loss for the period amounted to CHF -1.2m, mainly driven by increased development expenses for C-PTBE-01 (corticorelin). Cash flow amounted to CHF -1.0m. As planned, Curatis held a Type B meeting with the US Food and Drug Administration (FDA) on 9 September 2025.

Business development and finances

Product sales in the first half of the year amounted to CHF 5.0m and services revenues to CHF 0.2m. Curatis AG was able to increase the sales of its distribution business from CHF 4.6m (H1 2024) to CHF 5.2m (H1 2025) in the entire 6 months due to strong organic growth of the existing portfolio and new products, which corresponds to a growth of 14%. The loss for the period amounted to CHF -1.2m, driven mainly by significant investments in C-PTBE-01 in preparation for the planned Phase III clinical trial.

Curatis has a cash position of CHF 2.0m despite increased development expenses.

^* Curatis Holding AG acquired Curatis AG effective on 26 April 2024, and the acquisition is based on the values of the audited opening balance sheet as per 30 April 2024. Therefore, the financial statements as per 30 June, 2024 consolidate the activities, revenues and cost items of Curatis AG for the months of May and June 2024, and do not take into account the 4 months before the business combination.

For a more detailed discussion of the half-year figures, please refer to the half-year report and the associated management report, which are available on the Curatis website www.curatis.com.

Corticorelin  / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastates caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impared glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.  

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin, demonstrated the potential to substantially reduce, or in some cases completely replace steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States. 

Curatis met with the FDA on 9 September 2025 to achieve alignment on the design of a pivotal Phase 3 clinical trial for corticorelin as well as on key non-clinical and manufacturing aspects. The outcome of the meeting was positive. Further details will be published once the minutes of the FDA meeting are available. In Q3 of 2025, Curatis Holding AG began the process of partnering C-PTBE-01 (corticorelin) with global pharmaceutical companies active in oncology.

Outlook

The Curatis Group anticipates growth in its product and service revenues for 2025 compared to 2024. This growth is expected to be primarily driven by new products, notably four recently contracted products from Phoenix Labs in pain management and urology. These products generated approximately CHF 5 million in sales in 2024. Curatis Group’s objective remains to achieve a break even result in 2026 regardless of whether a partner for C-PTBE-01 can be secured. This would be achieved through substantially increased revenues and lower costs compared to 2025. 

About Curatis

Curatis Holding AG is a publicly listed company (CURN.SW) specializing in the late stage development and commercialization of drugs for rare diseases and specialty care. Curatis has a sales portfolio of more than 40 products and a pipeline of orphan and specialty drugs. More information can be found on the website www.curatis.com.

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