Investor relations

Bioceltix

We develop innovative therapies for veterinary use that harness the immunomodulatory properties of mesenchymal stem cells. We target common diseases in companion animals which result in high demand for new, more effective medicinal products.

The Bioceltix business model follows global quality standards for advanced therapy medicinal products (ATMPs) for humans. All biopharmaceuticals developed by Bioceltix will be subject to independent clinical trials to verify their quality and safety. We possess cutting-edge research and production facilities, cooperate with ambitious scientists, and operate based on a clearly defined commercialisation route. Our goal is to market new, effective solutions in the field of veterinary medicine.

The market environment

Spending on therapies for companion animals grows year by year. The American Pet Products Association estimates that in the United States alone, the spending reached about USD 69 billion in the years 2016-2017. Almost 15 billion USD (about 20%) was spent on pharmaceutical therapies.

140 thousand

the number of veterinarians working in private practice in the EU and the USA

30 billion USD

spending on treatment for companion animals in the USA and the EU in 2022

28%

increase in the share of biopharmaceuticals in the entire pharmaceutical market by 2020

At Bioceltix, we harness the therapeutic potential of MSCs to develop innovative biopharmaceuticals for companion animals focusing on diseases with high demand for new, effective therapies. The pharmaceuticals, intended for use in animals and based on the immunomodulatory mechanism of action of MSCs, will be an excellent alternative to symptomatic pharmacotherapy focused mainly on alleviating pain and inflammation.

Advantages of MSC-based biopharmaceuticals

1Mesenchymal stem cells (MSCs) used as an active pharmaceutical ingredient are a viable alternative to steroidal and non-steroidal anti-inflammatory drugs.

2MSCs induce natural pathways of intracellular signal transduction, having a strong anti-inflammatory, analgesic and pro-regenerative effect.

3MSCs are a long acting API whose therapeutic effect is based on stimulating the natural processes of the body – they cause no adverse reactions

4They can actively facilitate the regeneration of the damaged tissue

Our technology for developing and manufacturing MSC-based medicinal products for veterinary use utilises the therapeutic potential of allogeneic stem cells (one donor – many recipients).

This means that:

the pharmaceutical can be batch-produced, and the patient can be treated without the need for collecting their biological material and harvesting their own cells;
the pharmaceutical will be available off the shelf at the veterinary clinic, which increases treatment comfort and reduces treatment time;
the therapy can be used for animals suffering from conditions that would make it impossible to administer anaesthetic agents and collect a piece of adipose tissue for autologous stem cell harvesting.

Our innovations

Stem cells are one of the hottest issues in contemporary medicine. Their enormous and still not fully discovered potential inspires us to perform research studies on new drugs for the veterinary market. Our plan for the coming years includes pushing Bioceltix products into the next, key stages of development:

Biopharmaceutical candidates

Target group	Product	Therapeutic area	Stage
Dog	BCX-CM-J	Degenerative joint lesions (Osteoarthritis)	Pre-clinical trials
Dog	BCX-CM-S	Autoimmune and inflammatory diseases in dogs	Pre-clinical trials
Horse	BCX-EM	Tendon damage	Pre-clinical trials
Cat	BCX-FM	Gingivostomatitis	Pre-clinical trials

Research and development projects

Target group	Product under development	Intended use	Stage
Dog	Medicine for atopic dermatitis	Atopy in dogs	R&D
Dog	Tests and targeted therapy for lymphoma and leukaemia in dogs	Diagnosis and anti-cancer treatment in dogs	R&D
Dog/Horse	WJMSC – mesenchymal stem cells isolated from the foetal tissue of dogs and horses	Diseases and injuries of the muscoskeletal system, organ failure, and neurological diseases in dogs and horses	R&D
MSC-based biopharmaceuticals	Stem cell lyophilisation	A technology for obtaining a lyophilisate from stem cells to facilitate their revival directly before their administration	R&D

Business model

The business model of Bioceltix is based on:

conducting innovative R&D projects,
cooperation with renowned scientific units,
acquisition of intellectual property under the in-licensing model,
sale of rights to developed products under the out-licensing model,
sale of products to veterinary clinics via distributors operating in particular countries.

Current Bioceltix activities

Strategic activities of Bioceltix include reorganising the cGMP-compliant manufacturing facility around an isolated, pharmaceutical line for manufacturing stem cell-based biopharmaceuticals for veterinary use. The reorganisation is co-financed as part of the Fast Track (“Szybka Ścieżka”) competition organised by the Polish National Centre for Research and Development. The cost of the project is around PLN 5 million.
We are engaged in an individual dialogue with the European Medicines Agency (EMA) via the Scientific Advice procedure – the aim of the dialogue is to secure approval of the full registration process for our first pharmaceutical, BCX-CM-J.
We are developing new solutions in veterinary medicine, expanding our portfolio and our in-licensing partnerships: – in cooperation with the renowned Ludwik Hirszfeld Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences (IITD PAN) in Wrocław, we are developing methods of using monoclonal antibodies for the diagnosis and targeted anti-cancer treatment of canine lymphoma and leukaemia.