Bioceltix SA will build in Wroclaw the world’s largest stem cell factory
Bioceltix SA has called an Extraordinary General Meeting of Shareholders for June 3, at which a vote will be held on, among other things, a draft resolution to increase its share capital by issuing new shares. The aim is to finance the construction of a new stem cell plant to enable large-scale production of drugs for international sale.
The funds raised by the company will allow future industrial production of Bioceltix’s flagship projects: two for dogs – for osteoarthrosis and atopic dermatitis, and a third for horses suffering from degenerative joint changes. Production of drugs based on mesenchymal stem cell technology is already taking place at the current mid-scale plant operating to pharmaceutical standards, ensuring their manufacture for R&D, clinical trials and future pilot sales. The new plant will ultimately allow the company to increase its production capacity by several dozen times.
“Our current manufacturing facility should provide up to 30,000 therapeutic doses of the product for osteoarthrosis per year. This is a sufficient volume for pilot sales in selected markets, once the first product is approved. Instead, we need to prepare for a rapid increase in production, and for this we need a new manufacturing plant. Our strategy of selling products through an industry partner will require large volumes.”
– explains Dr. Ing. Pawel Wielgus, a member of the company’s board of directors.
The company estimates that acquiring the new plant’s capacity for large-scale pharmaceutical production will cost around EUR 9 million in the first stage. The multimillion-dollar investment is to be financed with funds raised from a share issue. The company assumes that “the subject of the offering will be shares comprising up to 20% of the company’s shares admitted to trading on the WSE as of the date of the offering, which will be addressed to investors with exclusion of pre-emptive rights, but with preservation of the pre-emptive right to take up shares by the company’s existing shareholders who meet certain criteria and on the terms and conditions specified in the issue resolution.” Bioceltix plans to conduct the offering in June this year. Its other assumptions are expected to be presented to investors and shareholders shortly. The company has entrusted mBank S.A. and Trigon Dom Maklerski S.A. to act as intermediaries in preparing and carrying out the offering. The company’s Investor Relations and financial advisor is cc group sp. z o.o.
Strategic project
The new plant will be built in Wroclaw, and should be launched in the second half of 2026. The plant will be located on an area of about 1,200 sqm.
“Our goal is to start certified production at the new plant as soon as possible. We need to take care of all the relevant elements so as to cover the entire production process. In its first full year of operation, the plant should reach a production capacity of at least 100,000 therapeutic doses of the osteoarthrosis product. The investment is designed so that further increases in production will be achieved by simply adding more units of equipment and gradually commissioning more incubation modules. We will try to make sure that these activities are already financed by revenue, debt or leasing. We also see the possibility of financing part of the investment with public funds. We will make every effort to make this happen.” – explains Pawel Wielgus.
The company is working on the concept for the new plant together with a technology partner specializing in the design of higher-grade infrastructure. The plant is expected to encompass the complete process of manufacturing medicinal products, from the collection of source material from donors through stem cell multiplication and packaging to product storage, along with quality control, analytical and R&D facilities.
As Bioceltix’s management emphasizes, the construction of the manufacturing plant is essential to realize the company’s business goals and gain a sustainable competitive advantage.
“It seems to us that currently no entity, and globally, is capable of producing for therapeutic purposes the amount of animal stem cells we plan to obtain from the new plant. If everything goes according to plan, our production facility will be the largest stem cell plant of its kind in the world. The outlay to set it up is of course considerable, but looking at the business potential behind it, we have no doubts about this investment.” – adds Pawel Wielgus, a member of Bioceltix’s board of directors.
“The timing for veterinary biotechnology is very good. Everything points to the fact that it is the biological drug that will be the first product in the history of veterinary medicine to reach annual sales in excess of $1 billion. On top of that, the attitude of caregivers towards animals is evolving all the time, as we increasingly treat them as full-fledged family members. We want to make the most of these trends, and our stock market plans go hand in hand with the advancement of projects.”
– Lukasz Bzdzion, CEO of Bioceltix, concludes.
Additional changes in the company’s shareholding are gearing up with the share issue. The Infini ASI fund, which has historically joined Bioceltix as the first financial investor, is considering joining the deal and selling its stake.
“First and foremost, we are grateful to Infini for its long-standing support, which has enabled us to pursue further goals and build added value for shareholders. Infini has been with us almost from the beginning, accompanying the company on its path from startup to regulated market. For me, it is as understandable as possible that each fund has its own investment horizon. I am glad that Infini’s board is making such important decisions in a way that corresponds to the company’s development plans. I think this is also good news for the other shareholders.” – emphasizes Pawel Wielgus.
Commercialization on the horizon
The company assures that it is maintaining a good pace of work in all the future drug product lines it has developed so far. In the case of the most advanced project for canine osteoarthrosis, Bioceltix intends to submit a registration dossier to the European Medicines Agency in May this year. This marks the start of official talks with the pharmaceutical regulator, which are expected to eventually lead to product approval next year. BCX-CM-J would then be the world’s first veterinary medicinal product containing canine stem cells. The drug candidate for canine AD, on the other hand, is in a proper multi-center clinical trial after the success of the pilot study. The development of the BCX-CM-AD project will be supported by a grant of nearly PLN 11 million under the European Funds for a Modern Economy (FENG) program. The company has also reached an important milestone in the BCX-EM project – the clinical trial has completed recruitment of 117 horses diagnosed with symptoms of osteoarthritis. According to management, the rapid and efficient recruitment of horses indicates strong market demand in this area. In parallel to the three flagship projects under development, Bioceltix has undertaken work on a new product for the treatment of AD in dogs. This will be a cell-free product using proteins and other substances produced and secreted externally by stem cells in the culture medium as the active pharmaceutical ingredient. The so-called secretome in the current technological process is a waste product, but the developers of Bioceltix see great therapeutic and commercial potential in it.
