Kinarus Therapeutics Holding AG / Key word(s): Acquisition/Corporate Action 26-Apr-2024 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR
Liestal, Switzerland, 26 April 2024: Curatis Holding AG (“CURN.SW“, “Curatis Holding” or the “Company“, formerly Kinarus Therapeutics Holding AG, and together with its wholly-owned subsidiary Curatis AG, “Curatis Group“), a SIX Swiss Exchange listed specialty pharmaceutical and therapeutic speciality medicine distribution and drug development company, today announces that it has successfully completed the business combination with Curatis AG (the “Business Combination“). As of today, the CURN.SW shares of the Company, under the new name Curatis Holding AG and with a relocated domicile to Liestal, Basel-Landschaft, are trading for the first time on the SIX Swiss Exchange.
As initial related transactions, a reverse share split (the “Reverse Share Split”) with a reverse share split ratio of 4,480:1 (together with a small capital increase of 111 shares of the Company to make the number of shares of the Company divisible by 4,480) and a share capital reduction, whereby the nominal value of each share of the Company was reduced from CHF 44.80 (immediately post Reverse Share Split) to CHF 0.10 per share, were carried out. As a result, the 1,310,176,000 shares of the Company (i.e previous KNRS.SW shares with a nominal value of CHF 0.01 per KNRS.SW share) were split into 292,450 CURN.SW shares with a nominal value of CHF 0.10 per CURN.SW share. Concurrently and as the main transaction of the Business Combination, Curatis Holding acquired by way of contribution in kind all outstanding shares of Curatis AG in a capital increase against a total consideration of 4,093,916 newly issued CURN.SW shares. As a result of all these transactions, the total number of outstanding CURN.SW shares is now 4,386,366 registered shares with a nominal value of CHF 0.10 each. Also, as part of the Business Combination, a Mandatory Exchangeable Loan Note with principal amount of CHF 4.55 million (the “Loan Note“) was placed with selected investors. This Loan Note has already been partially converted into new CURN.SW and, in accordance with the terms of the Loan Note, the remainder will be converted 61 trading days from today into between 112,780 and 368,699 shares, with the conversion price depending on the 60-day volume weighted average share price of the Company’s shares. With the total cash of CHF 4.36 million raised under the Loan Note, together with the net cash flow expected to be generated by the specialty medicine distribution business of the Curatis Group in the future, the Curatis Group expects to have sufficient funds to execute its base case business plan for the development of its lead product candidate C-PTBE-01. The Curatis Group: The Curatis Group is focused on the acquisition, development and commercialisation of innovative medicines for the prevention, diagnosis and treatment of rare diseases – often referred to as orphan diseases – and special care diseases. In recent years, orphan drugs have shown an above market growth compared to non-orphan innovative drugs in the past. Orphan drug development may be associated with a faster and less costly route to market, thereby reducing a company’s overall risk profile. The Group also operates a distribution business with a sizeable and historically profitable portfolio of interesting, marketed orphan and specialty products in Switzerland and has a pipeline of four promising projects in advanced and late clinical development, including KIN001, a proprietary compound platform developed by Kinarus with future potential. The Curatis Group thus represents an attractive, risk-balanced business model. Distribution business for orphan disease and specialty disease medicines Curatis has exclusive distribution rights in Switzerland for more than 30 different drugs developed by third party pharmaceutical companies – many of them orphan and specialty drugs. With Curatis AG now being part of a publicly listed group and the expected increase in public visibility and credibility, the Curatis Group aims to grow its speciality pharmaceuticals distribution business by expanding its product offering in Switzerland as well as geographically expanding its distribution business to large European markets such as Germany, France, the UK and Italy. Development business for orphan and specialty disease medicines Curatis Group’s strategy is to identify high unmet medical need indications for compounds for which safety and clinical efficacy data already exist, potentially allowing faster development with lower risk and investment through to commercialisation. The development projects have been selected in line with this strategy. C-PTBE-01 for the treatment of peritumoral brain edema in pediatric patients with diffuse intrinsic pontine glioma (“DIPG”) – next major development step: pivotal clinical study The Group is focusing its development activities for C-PTBE-01 on peritumoral brain edema (PTBE) in pediatric patients with diffuse intrinsic pontine glioma (DIPG). DIPG is an aggressive type of childhood cancer that forms in the brain stem. It is very rare and almost always occurs in the pediatric population. Approximately 150-300 patients are diagnosed with DIPG each year in the US. The average (median) overall survival for patients with DIPG is less than 1 year. PTBE refers to the accumulation of fluid in the brain tissue surrounding a tumor. It commonly occurs in brain tumors and can cause significant neurological symptoms and complications due to increased pressure within the skull. It may lead to symptoms such as headaches, seizures, neurological deficits, and altered mental status. Given the lack of curative options for most DIPG patients, supportive therapy aimed at maintaining quality of life plays a central role in the treatment of many patients. Corticosteroids are commonly used to treat PTBE. Their administration is typically associated with rapid symptom relief. However, corticosteroids can have severe side effects such as severe myopathies, muscle wasting, morbid weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension, and personality changes. C-PTBE-01 has shown a strong corticosteroid-sparing effect, which may allow a significant reduction in corticosteroid use. Phase I, II and III clinical data are available, and thus Curatis Group currently expects that only a pivotal study with a relatively small number of patients is envisioned for registration. C-PTBE-01 may be eligible for 7 years of orphan drug protection in the US and 10 years of orphan drug protection in the EU upon orphan drug designation and receiving market authorization. Curatis Group may apply for a Rare Pediatric Disease Voucher for C-PTBE-01. C-AM-01 for the prevention of severe migraine with aura (“MwA“) – next major development step: clinical phase IIb study An aura typically is a perceptual disturbance and includes a wide range of neurological symptoms. In some patients, changes in the cortex area of the brain cause changes in their sight, such as dark spots, colored spots, sparkles or ‘stars’, and zigzag lines. Numbness or tingling, weakness, and dizziness or vertigo (the feeling of everything spinning) can also happen. Speech and hearing can also be disturbed, and sufferers have reported memory changes, feelings of fear and confusion, and more rarely, partial paralysis or fainting. Migraine with Aura is a high unmet medical need indication. There is no approved preventive treatment that specifically targets MwA and its associated headache. MwA can cause significant disability on patients and compromise their daily life activity. MwA attacks are comparable to epileptic attacks in terms of unexpectedness and instant disability. MwA patients are 3 times more likely to have an ischemic stroke. Two Phase IIa clinical proof-of-concept studies suggest a reduction in the number of auras with C-AM-01. C-AM-01 has been granted a US patent covering its use and dosing regimen. In the EU, C-AM-01 would benefit from 10 years of data exclusivity and market protection. C-MOH-01 for the treatment and prevention of medication overuse headache (“MOH”) – next major development step: clinical phase IIb study Headache is one of the most prevalent disorders in human society and is responsible for substantial socioeconomic expenses. A general problem of headache treatment is the overuse of drugs. Patients, who tend to use acute medication to treat their headache on a frequent basis, like patients who report a history of migraine as well as patients that report tension type headache (TTH) are predestined for medication overuse headache (MOH). Instead of curing the pain, overuse leads to even heavier secondary headache which is much more difficult to treat and is referred to as Medication Overuse Headache (“MOH“). Economically, medication overuse headache is among the costliest of neurologic diseases and the costliest kind of headache disorder. Currently the treatment of choice for MOH is discontinuation of the overused medication although this is often associated with acute headache pain and withdrawal symptoms such as sleep disturbances, nausea, vomiting, anxiety, and depression. Thus, there is a significant unmet need for patients suffering from MOH. One Phase IIa clinical proof-of-concept study in chronic tension type headache is available for C-MOH-01. C-MOH-01 has been granted a US patent covering its use. In the EU, C-MOH-01 would benefit from 10 years of data exclusivity and market protection. KIN001 for the treatment of rare inflammatory and fibrotic diseases (e.g. idiopathic pulmonary fibrosis (“IPF”)) – next major development step: clinical proof-of-concept KIN001, developed by Kinarus, is a proprietary compound with potential in inflammatory and fibrotic diseases. KIN001 adds a significant new element to the Group’s pipeline. The Curatis Group intends to explore the potential of KIN001 in ultra-orphan inflammatory and fibrotic diseases and to pursue its own drug development for the identified ultra-orphan indications. The Curatis Group also plans to pursue KIN001 in idiopathic pulmonary fibrosis (“IPF”). IPF is a rare, progressive orphan disease of the respiratory system characterised by thickening and stiffening of lung tissue associated with the formation of scar tissue. It is a type of chronic scarring lung disease characterised by a progressive and irreversible decline in lung function. The tissue in the lungs becomes thick and stiff, affecting the tissue surrounding the air sacs in the lungs. Symptoms typically include gradual shortness of breath and a dry cough. Other changes may include fatigue and abnormally large and dome-shaped finger and toenails (nail clubbing). Complications may include pulmonary hypertension, heart failure, pneumonia or pulmonary embolism. There is no cure for IPF and there are currently no procedures or medicines that can remove the scarring from the lungs. Current treatments are focused on slowing the progression of lung scarring and do not necessarily reduce the symptoms of coughing and breathlessness. KIN001 has shown beneficial effects in reducing IPF in a well-characterised animal model of IPF. The Curatis Group has licensed patent rights relating to the drug combination as well as patent rights and know-how relating to IPF in this drug combination. The Group intends to explore out-licensing opportunities in IPF. The following graph is a projected Development Roadmap. It shows the currently assumed development plan of the Curatis Group’s product candidates, highlighting potentially important inflection points over the next 5 years. Development Roadmap About the Curatis Holding Group: Curatis Holding AG is a publicly listed specialty pharmaceutical company with a distribution and drug development business. The focus of the Curatis Group’s business activities is on high unmet medical need orphan and ultra-orphan indications, pursued via its wholly owned operating subsidiary Curatis AG. The Curatis Group was formed by the Business Combination of Kinarus Therapeutics Holding AG and Curatis AG in April 2024. For more information, please visit the company’s website at www.curatis.com. Investor Relations Contact: YUMA Capital
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