CEO’s foreword

The year 2015 was a significant step in the implementation of the company’s strategy. The company’s financial position was strengthened by the listing on the First North Finland market in the summer, making it possible to continue current research projects.

The company’s strategy to focus on making use of the patented GTU® technology for next generation medical treatments is beginning to show results. In the autumn of 2015, the company reported favourable results from the application of GTU® technology in gene-based treatments. During the review period, this technology has become a viable commercial option for the company as a result of our present studies and the strong transition taking place in the pharmaceutical market. In December 2015, the company filed a patent application for gtGTU® technology (gene therapy, Gene Transportation Unit). The present extended studies, which precede the gtGTU® clinical studies, will use antibodies mimicking proper medical treatment. The pre-clinical studies have taken longer than assessed. The company will begin to commercialise the gtGTU® technology when the initial results from the extended studies have been completed. Significant agreements between biotechnology companies and major pharmaceutical companies have been announced in the market during the review period, which strengthen the company’s view of business opportunities and prove that it is on the right strategic path.

During the review period, the company received confirmation that the Horizon 2020 consortium had proceeded to the final stage of the grant application process and to contract negotiations with the European Commission based on the research plan of the consortium. The consortium (EHVA, European HIV Vaccine Alliance) is a significant step in European cooperation for the development and testing of new preventive and treatment vaccines. The most authoritative independent players in the field have rated the company’s technology as very high in quality. After the review period, the project has proceeded to the signing of the financing agreement. If obtain positive results are obtained from clinical trials, these results will further promote the commercialisation of the GTU® technology. The trial products of the project will be manufactured in the company’s GMP-level (Good Manufacturing Practice) production facilities. The entire project will continue until 2021.

The company is now preparing to relaunch the GMP production, which was interrupted due to financial reasons. The company’s strategic strength is its ability to maintain its own GMP-level production facility, where it can produce vaccines used in clinical trials. The production machinery and equipment used meet government requirements and enable pure and safe vaccine production.

The Chinese pharmaceutical market is growing at a fast pace and the demand for modern biomedicines is increasing. The company believes that this trend will provide it interesting growth opportunities in the mid-term. New and better vaccines are also needed for the medication of production animals. During the review period, the company made progress in China to achieve a license agreement, and a heads of agreement was signed with QYH Biotech Company Ltd regarding poultry vaccines in March 2015. Initial studies aiming at making a license agreement have taken longer than assessed, and they are still ongoing.

The successful initial public offering bolstered the company’s capital allowing it to implement its plans and strengthened its financial structure. The company gained in total around 200 new shareholders in the initial public offering. As a listed company, FIT Biotech is now an even more viable partner in the eyes of potential international licensing partners.

FIT Biotech offers investors the opportunity to participate in the long-term development of completely new types of medicines in the areas of gene-based treatments, such as for cancer; infectious diseases, such as for HIV and tuberculosis; and animal vaccines. I am grateful for the investors’ interest toward the company. We aim to be actively involved in events that are particularly targeted at private investors. I thank the company’s old and new investors, its committed personnel and international business partners for the past year for together enabling the successful operation of the company.

Rabbe Slätis
CEO
FIT Biotech Oy