First Parkinson's patients in the NEON study treated
On December 14, 2021, the clinical trial (NEON trial) was started with the treatment of the first Parkinson's disease patient. In an initial, stepwise dose escalation, the maximum therapy dose for the treatment of Parkinson's disease will be determined for the first three patients. In the meantime, all three patients were able to start dose escalation. Weekly treatment is intravenous and the maximum therapeutic dose is expected to be determined in May 2022. Thereafter, an additional nine patients will be enrolled in the study and further data on tolerability will be collected. In addition, regular examinations will be conducted during the treatment period to assess the health status of the patients.
The treatment of neurodegenerative diseases such as Parkinson's poses a major challenge, as most active substances cannot reach their site of action in sufficient quantities through the blood-brain barrier. This was also true for the active ingredient GM1, whose positive effect in the treatment of Parkinson's patients has already been proven by clinical studies, but could only be achieved by twice-daily subcutaneous administration - a treatment regimen that is not feasible for patients on long-term therapy. InnoMedica intends to deliver GM1 efficiently to the intended site of action by using a nanocarrier specifically optimized to penetrate the blood-brain barrier. In addition, drugs for Parkinson's disease usually aim to compensate for the lack of dopamine (neurotransmitter) in order to alleviate symptoms. InnoMedica, on the other hand, exploits the neuroprotective effect of GM1 with the aim of slowing down the progression of the disease and halting it in the long term. By protecting the nerve cells from dying, the body's own dopaminergic system shall be maintained. In this way, the body is expected to produce more dopamine on its own again and should be less dependent on an artificial supply from the outside. Treatment with GM1 encapsulated in InnoMedica's nanocarrier is added to the patient's existing therapy and aims to reduce the severity of Parkinson's and stabilize it at the lower level reached.
New results in orphan designated indication ALS in preclinical studies
After receiving orphan drug designation for use in amyotrophic lateral sclerosis (ALS), InnoMedica has further strengthened its collaboration with Prof. Dr. Smita Saxena at the University of Bern. The expert in the field of ALS research achieved further results in new preclinical studies with GM1 in InnoMedica's nanocarrier in ALS mouse models, which provide basis for application in patients. To further support the potential for the treatment of neurodegenerative diseases, the experiments will be continued. In parallel, InnoMedica is preparing a clinical trial for the indication ALS. This study planning will already take into account the dose finding data from the ongoing NEON study in Parkinson's patients.
Capital increase 2022
With the start of the NEON study for the treatment of Parkinson's disease, the latest promising preclinical studies for use of this drug in ALS models and the ongoing preparations for a clinical study in ALS patients, InnoMedica was able to make important progress. As an orphan drug for the indication ALS, a marketing authorization can already be obtained from Swissmedic in a simplified and accelerated procedure while the clinical efficacy study is still ongoing. Internationally, a rapid progress is also favored given the orphan drug status from the FDA and EMA.
To finance the next two years, InnoMedica will conduct a capital increase in spring 2022. The preliminary round, which is designed for larger investments, will run until April 8, 2022, and offers interested investors the possibility of a comprehensive examination of the investment and a secure allocation by means of subscription rights in direct contact with Dr. Jonas Zeller, Chief Financial Officer (firstname.lastname@example.org). The preliminary round will be followed by a public offering in April, in the context of which both the existing shareholders and new investors will be addressed. The capital increase provides for an offer of a maximum of 466,000 registered shares at a share price of CHF 40.70 with a nominal value of CHF 0.10, resulting in a maximum capital raising of CHF 19 million.
As in the capital increase 2021, InnoMedica was able to agree with a group of existing shareholders, who already invested in InnoMedica more than 20 years ago, that they will also contribute 466,000 shares at a preferential price of CHF 10.18 to the offer of the capital increase 2022 via a bonus option. For each subscription of a new share at a price of CHF 40.70, the investor will receive the right to acquire another share at a price of CHF 10.18 from the existing shareholders via a bonus option. By following the price proposal of the Board of Directors of InnoMedica Holding AG and thus foregoing a significant part of the potential return, the existing shareholders make a significant contribution to the attractiveness of the subscription of new shares and enable an average share price of CHF 25.44. The Board of Directors continues the active restructuring of the shareholder base which was already initiated in the capital increase 2021. It thereby takes into account the adjusted risk profile of the company and ensures a balanced benefit for all shareholders. With their investment, the existing shareholders have supported InnoMedica's high-risk phase. As the company moves closer to the market, the risk decreases but the capital requirement increases, appealing to a new segment of investors.
You can find the audited Annual Report 2021 here. The complete documentation of the capital increase including the subscription form will be sent to the shareholders and interested investors at the beginning of the capital increase.