Curatis: Significantly Increased Sales in Core Business and Projects in Development Pipeline on Track

Curatis Holding (SIX:CURN) reports revenues of CHF 2.0m for H1 2024, whereby Curatis AG is only included for 2 months. Curatis AG was able to increase sales in the distribution business by 31% per cent to CHF 4.3m in the entire 6 months of 2024 compared to the first 6 months of 2023. The loss amounted to CHF 3.8m due to non-cash one-off effects and amortisation as well as transaction costs for the acquisition of Curatis AG. Cash flow, including one-time transaction costs for the business combination of over CHF 1 million, was CHF -0.7m. As planned, Curatis also submitted the orphan drug designation application for its lead product candidate C-PBTE-01 to the US Food and Drug Administration (FDA) and expects a response from the FDA in Q4 2024.

Business development and finances

Product sales in the first half of the year amounted to CHF 1.75m and services revenues to CHF0.23m, whereby Curatis AG, which was acquired on 26 April 2024, is only included in this figure for 2 months. Curatis AG was able to increase the sales of its distribution business from CHF 3.3m (H1 2023) to CHF 4.3m (H1 2024) in the entire 6 months due to strong months in May and June, which corresponds to a growth of 31%. This strong growth is consistent with the growth of Curatis AG before listing over the past three years. The loss for the period amounted to CHF 3.8m and includes several non-cash-relevant special effects such as personnel costs due to the revaluation of the option plan that Curatis has operated since 2015 (CHF 2.5m) and the amortisation of intangible assets booked as part of the acquisition (CHF 528k). It also includes the one-time costs of processing the transaction totalling over CHF 1m.

Curatis‘ strong cash position of CHF 3.5m combined with a positive cash flow from operating activities (excluding transaction costs) and its lean organisation is expected to secure Curatis’ operating activities for years to come. Possible income from partner contracts in 2025 is not included in this figure.

In CHFm	30 June 2024	30 June 2023
Revenues	1.979	0
Operating result	(3.297)	(2.087)
Of which non-cash effects	(3.029)	0
Cash and cash equivalents	3.463	0.009 (per 31.12.2023)

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.

Business model

The Curatis Group distributes speciality pharmaceuticals and develops its own medicines with a focus on orphan and ultra-orphan indications. In the distribution business, the aim is to increase sales by securing additional drugs for distribution in Switzerland and expanding the distribution business geographically to key European markets. The Group's development portfolio consists of four product candidates, whereby an additional pivotal study with a relatively small number of patients is expected to be sufficient to obtain marketing authorisation for the lead project.

C-PBTE-01

Curatis is focusing its development activities for C-PTBE-01 on an extremely rare group of aggressive brain tumours (Diffuse Midline Glioma, DMG). These tumours mainly affect children, with most cases being diagnosed between the ages of 5 and 9. In the USA, around 800 patients are diagnosed with DMG every year; in Europe, the number is in the same order of magnitude, which is why the disease is considered a rare disease for regulatory purposes. In connection with DMG, indirect brain damage regularly occurs due to an accumulation of extracellular fluid in the vicinity of the tumour. This peritumoural brain edema (PTBE) 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.

Currently, the typical 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, high blood pressure and personality changes. The already serious side effects are exacerbated in children. 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 and thus to the alleviation of severe steroid-induced side effects, improving the quality of life of children and their parents.

Curatis submitted the Orphan Drug Designation application for C-PTBE-01 to the FDA in the current quarter. In 2025, Curatis plans to start a pivotal Phase III trial with C-PTBE-01 and, in parallel, enter into discussions with potential partners for distribution in the USA.

C-AM-01

Migraine is a common headache disorder. It is ranked by the World Health Organisation as the 19th most disabling disease in the world. According to published data, the prevalence of migraine is around 15-20% of the total population. About 15%-30% of migraine patients experience migraine with aura (MwA). Typically, an aura is a perceptual disturbance and encompasses a wide range of neurological symptoms. In some patients, changes in the cortex region of the brain cause changes in vision, such as dark spots, coloured spots, sparks or ‘stars’ and zigzag lines. Speech and hearing may also be impaired and sufferers report memory changes, feelings of anxiety and confusion and, less commonly, partial paralysis or flickering. MwA seizures are sometimes comparable to epileptic seizures. MwA patients are three times more likely to suffer an ischaemic stroke.

Curatis' C-AM-01 is targeted at the severe segment of MwA and thus addresses an unmet medical need. There is currently no approved preventive treatment specifically targeting MwA and the associated headache.

In the USA, Curatis was granted a patent of use and dosage regimen for C-AM-01 in November 2021. In the EU, C-AM-01 would benefit from extensive data exclusivity rights and market protection. C-AM-01 is currently in Phase IIa and the next development step for C-AM-01 is a Phase IIb dose-finding clinical trial. Curatis is seeking to partner the product candidate for further development and global commercialisation.

C-MOH-01

Headaches are one of the most widespread diseases in society and cause considerable socio-economic costs. The cost of lost work time far exceeds the cost of medical care. One problem with headache treatment is the over-utilisation of medication. Patients who overuse acute medications to treat their headaches are susceptible to medication-overuse induced headache (MOH). Instead of relieving the pain, the overuse leads to an even more severe secondary headache that is very difficult to treat. Economically, MOH is one of the most expensive neurological conditions and is the most expensive type of headache disorder.

The standard treatment for MOH is currently cessation of excessive medication, which is often associated with acute headaches and withdrawal symptoms such as sleep disturbances, nausea, vomiting, anxiety and depression. There is also a significant risk of relapse after discontinuation of treatment. No drug is currently approved for the treatment of MOH.

In the USA, Curatis, together with its partners Danish Headache Center (Glostrup, DK) and the University of Copenhagen (DK), was granted a patent of use for C-MOH-01 in December 2021. In the EU, C-MOH-01 would benefit from extensive data exclusivity rights and market protection. The product candidate is currently in Phase IIa and the next development step for C-MOH-01 is a Phase IIb dose-finding clinical trial. Curatis is seeking to partner C-MOH-01 for further development and global commercialisation.

KIN001

Curatis' fourth product candidate is KIN001 for the treatment of idiopathic pulmonary fibrosis (IFP). This is a rare progressive disease of the respiratory system with chronic scarring of the lung tissue. Symptoms include the gradual onset of breathlessness and dry cough and complications include pulmonary hypertension, heart failure, pneumonia or pulmonary embolism. KIN001 has shown positive effects in reducing IPF in an animal model of IPF.

The next development step for KIN001 is a clinical phase II proof-of-concept study. Curatis is evaluating the product candidate in other rare and very rare indications with high medical need, which is in line with the Group's strategy.

About Curatis:

Curatis Holding AG is a listed company (CURN.SW) that specialises in the development and marketing of drugs for rare and very rare diseases. Curatis has a sales portfolio of more than 30 drugs and a pipeline of orphan drug products and specialist products that can make a significant contribution to cash flow from 2025 onwards. You can find more information on the website www.curatis.com

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