On August 28, Hemcheck was conditionally approved for continued listing on Nasdaq. After that, a lot of work has been done to implement all the steps necessary to complete the transaction with Bio Vitos. At the same time, preparatory work is underway to realize the value of the acquired IP rights, after the transaction is fully completed.

Implemented measures and next steps regarding the transaction with Bio Vitos

Hemcheck has to date completed many of the necessary steps to complete the transaction with Bio Vitos, including that the existing business has been placed in a wholly owned subsidiary (Hemcheck Management AB), the distribution of Hemcheck Holding AB to current shareholders, the acquisition of the IP rights has been completed, and a notice to an extraordinary general meeting has been prepared (where the decision to change the company name and new board of directors is to be decided on) and will be published when the date of the extraordinary general meeting is decided by the board. The new share issue to Bio Vitos is also planned to be carried out shortly. When the new issue is completed and the extraordinary general meeting has been held, there are only minor administrative tasks left such as updating the website which is required for all conditions set by Nasdaq to be met.

Simultaneously with the work to complete the transaction with Bio Vitos, the preparatory work is underway to realize the value of the acquired IP rights.

Patent

The process of obtaining patents in the relevant countries is ongoing. No further questions have been raised by the patent authorities in the US and Europe, which is positive, says Igor Lokot, intended new board member of Hemcheck and CEO of Double Bond Pharmaceutical, which owns part of Bio Vitos and was the company that was involved in developing the IP- rights from the start. Although a patent application provides some protection as competitors can be deterred, it will be worth a lot to have the patent applications formally approved.

Registration

As previously announced, when the transaction with Bio Vitos is completed, Hemcheck will begin the work to register the substance oral iron succinate as a drug, which the IP rights cover for the treatment of patients with heart failure with reduced ejection fraction, under the name Succifer. This process is now being prepared and various options are being considered so that the work can begin as soon as the transaction is completed.

Further studies and new areas for commercialization

Succifer was originally developed for heart failure patients with the aim of replacing expensive and cumbersome intravenous iron treatments, while maintaining efficacy for the patients. The relevant market is large, where the most common intravenous drug has a turnover of over SEK 5 billion in this segment. This segment is the first priority for the company to compete in.

Today’s available iron tablets are not very effective, and the plan is as previously communicated, to also apply for a drug approval for Succifer for better iron absorption, iron saturation and iron storage for people with low iron values ​​who do not suffer from heart failure. The potential market for that is very large.

To take the next step in that work, a study is now being prepared in which elite female basketball players in Europe are intended to participate. The aim of the study is to show that Succifer, which today is proven to have good efficacy in the treatment of patients with heart failure, is also a better alternative than ordinary iron tablets for women with low values ​​of iron in the blood. The plan is that the study will begin at the beginning of 2024, aiming that it will be completed during Q2 2024. Good results from that study can open up further commercial potential and the company also intends to investigate the possibility of broadening the existing patent applications to also include this patient group. 

Manufacturing and logistics

To be well prepared when the commercial phase begins, the company needs to secure its supply chain. That work will begin shortly. There are several reliable contract manufacturers in the market who can manufacture Succifer, as the substance itself is not complicated to manufacture, so it is a matter of choosing a good and reliable partner, which we have experience with before, says Igor Lokot.

The company intends to regularly update the market with more information about what is happening in the completion of the transaction with Bio Vitos and the work to realize the value of the acquired IP rights.

For further information contact:

Hemcheck Sweden AB (publ)

Joen Averstad, acting CEO

Tel: +46 76 108 8191

Email: joen.averstad@hemcheck.com

About Hemcheck

Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection. The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes. Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately and is also a biomarker for acute medical conditions. Hemcheck’s goal is to contribute to improved healthcare by offering user-friendly solutions for the detection of hemolysed blood samples in direct connection with blood sampling near the patient. By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs. The company is listed on the Nasdaq First North Growth Market.

FNCA Sweden AB, 08-528 00 399, info@fnca, is the Certified Adviser to the company.