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Bioceltix Amplifies Efforts to Launch a Large-Scale Stem Cell Manufacturing Facility for Veterinary Medicine

COMPANIESBioceltix Amplifies Efforts to Launch a Large-Scale Stem Cell Manufacturing Facility for Veterinary Medicine
  • A biotechnology company listed on the stock exchange, developing veterinary drugs for companion animals, is intensifying efforts to start constructing a large-scale stem cell manufacturing facility that will operate under pharmaceutical quality standards.
  • The new facility will provide the biotech company with the anticipated production scale for drugs based on the proprietary ALLO-BCLX technology, aimed at combating the most common diseases in dogs: osteoarthritis and atopic dermatitis, and arthritis in horses. The project is estimated to be worth about 9 million EUR.
  • In connection with the construction of the manufacturing facility, the company plans to issue new shares amounting to up to 20% of the shares currently traded.

On June 3rd, Bioceltix SA has called an Extraordinary General Meeting of Shareholders, at which a vote will be held on a resolution proposal concerning a capital increase through the issuance of new shares, aimed at financing the construction of a new stem cell manufacturing facility that will enable large-scale drug production for international sales.

The funds raised by the company will enable the industrial production of Bioceltix’s flagship projects: two intended for dogs – for osteoarthritis and for atopic dermatitis, and a third intended for horses suffering from degenerative joint changes. Drug production based on technology utilizing mesenchymal stem cells is already taking place in the current, medium-scale manufacturing facility operating under pharmaceutical standards, ensuring their production for R&D, clinical trials, and future pilot sales. The new facility will ultimately increase production capacity many times over.

Our current factory should provide up to 30,000 therapeutic doses of the product for osteoarthritis annually. This volume is sufficient for conducting pilot sales in selected markets, following the approval of the first product. However, we need to prepare for a rapid increase in production, and for that, we need a new factory. Our strategy, which involves selling products through an industry partner, will require large volumes explains Dr. Eng. Paweł Wielgus, a member of the company’s board. The therapeutic products we are developing are at such an advanced level that we have decided to move forward with the next milestones we have set on the company’s development path. We are approaching the commercialization of our first drug, for canine osteoarthritis. The documentation for this medicinal product will be submitted to the European Medicines Agency (EMA) in May. Increasing production capacities will allow us to secure a strong market position and build a lasting competitive advantage adds Paweł Wielgus.

The company estimates that achieving large-scale pharmaceutical production capacity by the new facility will consume about 9 million EUR in the first phase. The multi-million investment is to be financed through funds raised from the issuance of shares. The company assumes that “the subject of the offer will be shares comprising up to 20% of the company’s shares admitted to trading on the Warsaw Stock Exchange as of the date of the offer, which will be directed to investors excluding the pre-emptive right but maintaining the right of first refusal to subscribe for shares by existing shareholders of the company who meet specified criteria and on the terms set in the issuance resolution.” Bioceltix plans to conduct the offer in June this year. The remaining assumptions of the offer will soon be presented to investors and shareholders. The company has entrusted the brokerage of preparing and conducting the offer to mBank S.A. and Trigon Dom Maklerski S.A. The company’s Investor Relations and financial advisor is cc group sp. z o.o.

Strategic Project

The new facility will be located in Wrocław, and its launch is expected in the second half of 2026. The manufacturing facility will be located on approximately 1200 m2.

Our goal is to launch certified production in the new facility as soon as possible. We must take care of all important elements, so as to encompass the entire production process. In its first full year of operation, the factory should achieve a production capacity of at least 100,000 therapeutic doses of the product for osteoarthritis. The investment is designed to further increase production by simply adding more devices and gradually launching additional incubation modules. We will strive to ensure that these activities are financed from revenues, debt, or leasing. We also see the possibility of financing part of the investment from public funds. We will make every effort to make this happenexplains Paweł Wielgus.

The company is working on the concept of the new facility together with a technological partner specialized in designing infrastructure of increased cleanliness class. The facility will encompass the

complete process of manufacturing medicinal products, from sourcing raw material from donors through multiplication and packaging of stem cells, to storing products, along with quality control, analytical facilities, and research and development.

As emphasized by the management of Bioceltix, building the manufacturing facility is necessary to achieve the company’s business goals and secure a lasting competitive advantage.

It seems to us that currently no entity, on a global scale, is capable of producing in therapeutic purposes such a quantity of animal stem cells as we plan to obtain from the new facility. If everything goes according to plan, our production facility will be the largest stem cell manufacturing facility of its kind in the world. The investments for its launch are of course significant, but looking at the business potential behind it, we have no doubts about this investment – adds Paweł Wielgus, a member of the board of Bioceltix.

The time for veterinary biotechnology is very good. Everything indicates that a biological drug will be the first in the history of veterinary medicine to achieve annual sales exceeding 1 billion dollars. In addition, the approach of pet owners is evolving, as we increasingly treat them as full members of the family. We want to make the most of these trends, and our stock market plans go hand in hand with the advancement of projects – summarizes Łukasz Bzdzion, president of the board of Bioceltix.

With the issuance of shares, additional changes are being prepared in the company’s shareholder structure. The fund Infini ASI, which historically joined Bioceltix as the first financial investor, is considering joining the transaction and selling its share package.

– Above all, we are grateful to Infini for their long-term support, thanks to which we were able to achieve further goals and build added value for shareholders. Infini has been with us almost from the beginning, accompanying the company on the path from startup to regulated market. For me, it is perfectly understandable that every fund has its investment horizon. I am glad that the management of Infini is making such important decisions in a way that corresponds with the company’s development plans. I think this is also good news for the remaining shareholders emphasizes Paweł Wielgus.

Commercialization on the Horizon

The company ensures that it maintains a good pace of work in all previously developed lines of future medicinal products. In the case of the most advanced project concerning osteoarthritis in dogs, Bioceltix intends to submit registration documentation to the European Medicines Agency in May this year. This means the beginning of official discussions with the pharmaceutical market regulator, which should consequently lead to the product being allowed to trade next year. Then, BCX-CM-J would be the first veterinary medicinal product in the world containing canine stem cells. Meanwhile, the candidate for a drug for atopic dermatitis in dogs, after the success of the pilot study, is in the phase of a proper, multicenter clinical trial. The development of the BCX-CM-AD project will be supported by a grant of nearly 11 million PLN under the European Funds for a Modern Economy (FENG) program. The company has also reached an important stage in the BCX-EM project – in the clinical study, recruitment of 117 horses diagnosed with degenerative joint changes symptoms has been completed. According to the management, the fast and efficient recruitment of horses indicates a large market demand in this area. Concurrently with the development of the three flagship projects, Bioceltix has begun work on a new product intended for the treatment of atopic dermatitis in dogs. This will be a cell-free product using as an active pharmaceutical ingredient proteins and other substances produced and secreted externally by stem cells, found in the culture medium. The so-called secretome in the current technological process is waste, but the creators of Bioceltix recognize its significant therapeutic and commercial potential.

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