Curatis: Sales growth of 30% in distribution - plus significant expansion of patient target group for lead project C-PTBE-01

Curatis Holding AG (SIX:CURN, ‘Curatis’) reports business revenues of CHF 6.9m for 2024, whereby Curatis AG is only included for 8 months. Curatis AG was able to increase sales in the distribution business by 30% per cent to CHF 9.5m in the full year 2024 compared to 2023.

Further key statements:

• Curatis is increasing the estimate for the number of patients addressed in the lead project C-PTBE-01 by a factor of 20.
• The reason for this is that Curatis can apply for a biologics licence for C-PTBE-01, which grants 12 years of market protection in the USA. This suggests an expansion of the indications, namely from PTBE in diffuse midline glioma (DMG) in children to PTBE in other primary and metastatic brain tumours in children and adults.
• A meeting with the US Food and Drug Administration (FDA) to discuss a potential pivotal Phase III trial for C-PTBE-01 is in preparation and is targeted for Q2.
• The strong cash position of CHF 3m at the end of the year combined with the positive, growing cash flow from sales and the lean organisation provide a solid foundation for Curatis' operating activities.

Business Development and finances

Product revenue in 2024 amounted to CHF 6.4m and service revenue to CHF 0.5m, whereby Curatis AG, which was acquired on 26 April 2024, is only included in this figure for 8 months. On a full year basis, Curatis AG was able to increase sales in its distribution business from CHF 7.3m (2023) to CHF 9.5m (2024), which corresponds to growth of 30%. This strong growth is due to significant organic growth as well as newly launched products. It is in line with Curatis' strategy to support products in the registration phase in order to subsequently assume responsibility for distribution, as well as to take over already launched products from competitors. The operating loss for the period amounted to CHF 3.3m and includes several non-cash-relevant special effects such as personnel costs due to the revaluation of the option plan that Curatis AG has operated since 2015 (CHF 2.5m). In addition, one-off costs were incurred in relation to the transaction in April 2024 (approx. CHF 1.3m).

The strong cash position of Curatis as at 31 December 2024 of CHF 3.0m combined with a positive cash flow from the operating business of Curatis AG (excluding transaction costs and development costs) and the lean structure secure the operating activities of Curatis.

In CHFm	31. December 2024	31. December 2023
Revenues	6.9	0
Operating Result	(3.3)	(16.3)
Thereof non-cash	(2.5)	(12.4)
Thereof transaction costs	(1.3)	0
Cash and cash equivalents	3.0	0

Lead project C-PTBE-01: Significantly more addressable patients

On 14 November 2024, Curatis announced that the approval of the lead project C-PTBE-01 will be sought via the Biologic License Application (BLA) route. While the path of the Phase III study and approval with a focus on children is not expected to change, the development of C-PTBE-01 will no longer focus solely on PTBE in children with Diffuse Midline Glioma (DMG). The expanded target population will now include children and adults with PTBE in primary and metastatic brain tumours. Curatis is evaluating conducting a study in adult patients with PTBE shortly after the paediatric study.

Curatis is therefore increasing the estimate of the addressable patient pool from less than 1,000 patients (PTBE in children with DMG only) in the US today to approximately 20 times the number of patients in the US (children in other indications as well as adults). The same applies to regions outside the USA.

Outlook for 2025: Stable sales and earnings growth and progress expected with C-PTBE-01

The first months of 2025 were in line with the budget. Curatis is confident that it will be able to further increase sales in 2025.

CMC development activities (active pharmaceutical ingredient and drug product) for C-PTBE-01 are proceeding according to plan. A first batch of the active ingredient has now been produced. A meeting with the US Food and Drug Administration (FDA) to discuss a possible pivotal Phase III trial for C-PTBE-01 is in preparation. The meeting with the FDA is planned for Q2 2025. Initial discussions are also taking place in the area of partnering and will be intensified after the meeting with the FDA.

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

There will be no presentation on the annual figures, but the company will be available to answer questions. The Annual General Meeting will take place on 23 May 2025 at 2.30 pm in Pratteln.

More detailed information on C-PBTE-01

Peritumoural brain edema is associated with many primary and metastatic brain tumours, leading to indirect impairment of brain function due to accumulation of extracellular fluid around the tumour. Peritumoural brain edema can cause symptoms such as headaches, vomiting and neurological dysfunctions such as paralysis, speech disorders, visual problems and altered mental status. They can be life-threatening.

The standard treatment for PTBE is the use of corticosteroids. These often have serious side effects such as severe myopathy, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. C-PTBE-01 has shown a strong steroid-sparing effect in two clinical safety and efficacy studies, which can lead to a significant reduction or complete replacement of steroid use. This can alleviate the severe steroid-induced side effects and thus improve the quality of life of those affected.

About Curatis:

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

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