News

New listing of POLTREG

The company POLTREG S.A. was newly listed on the GPW Main Market on 23 November 2021.
POLTREG S.A. is the 426^th company listed on the Main Market and the 12^th new listing on the Main Market in 2021.

Key information

*at the issue price of series M shares, i.e., PLN 75 

Issuer’s history
The Issuer was incorporated on 7 September 2016 and entered in the Register of Companies of the National Court Register on 15 September 2016. The registered office of PolTREG S.A. is Gdańsk (80-855), ul. Wały Piastowskie 1/1508 (Poland). The country of incorporation of the Issuer is the Republic of Poland. The Issuer conducts operations in the form of a joint stock company under the laws of Poland.

Issuer’s business
The Issuer is a biotechnology company and its core business is the development of a polypharmacology platform as a basis for the development of innovative therapies using T-regulatory cells (lymphocytes) (TREGS) as well as the development of combination therapies based on treatment with TREGS and antibodies, among others. Such therapies are a new development in endocrinology, opening up a new area of medical science: immuno-endocrinology (e.g., TREGS in combination with rituximab, an anticancer and immunosuppressive drug). The Company is also researching and developing the use of more advanced antigen-specific and genetically modified CAR-TREGS (collectively referred to as Treg 2.0), which may form the basis of therapies under development in the future as they allow a patient’s TREGS to be modified in the laboratory in the absence of certain characteristics or, if it is possible to modify them, increase efficacy for a particular disease. 
The therapeutic area in which the Company’s therapies will be used is autoimmune diseases, i.e., diseases in which the immune system attacks its own body. Depending on the classification, this category includes more than 100 diseases; most of them are chronic diseases with complications increasing over time. These are incurable diseases where the available treatment only delays the progression of the disease (e.g., there are no disease-modifying drugs for type 1 diabetes at all, i.e., drugs preventing irreversible changes in the patient’s body). The TREGS therapies and combination therapies using TREGS developed by the Company give rise to expectations of therapies which modify the course of the disease and improve the patient’s condition. The therapies the Company is working on are cell therapies which involve the use of human cells; they are classified in the currently most advanced group of drugs known as living drugs. These also include CAR-T therapies, i.e., immunotherapies with genetically modified T lymphocytes, as well as mesynchymal stem cell therapies. Cellular therapies are a rapidly growing area of medical science and an opportunity to create effective, ground-breaking targeted therapies. T-regulatory lymphocytes (TREGS) are a special population of immune cells. Although they make up less than 1% of leukocytes in peripheral blood, TREGS regulate the immune response so that pathogens are rapidly eliminated and own tissues remain protected from autoimmunity. As such, TREGS play a role in many pathological and physiological processes occurring in the human body, such as autoimmunity, chronic infections, allergies, interaction with bacterial flora, organ transplantation, maternal-fetal tolerance, and anti-tumour response. The reduction of the quantity of TREGS, or their malfunction, may trigger autoimmune diseases. The solutions and technologies developed by the Company make it possible to increase the quantity of TREGS in a patient without losing the regulatory activity of such cells, and may even increase such activity. The solutions consist in taking the patient’s blood, isolating TREGS from the blood, their proliferation in the laboratory without changing their properties (from 0.5 million to 2-4 billion cells in 10 days), and then administering the TREGS preparation to the patient. The Company is a global pioneer in this area: it has carried out the world’s first administration of TREGS in humans and its therapy for the treatment of type 1 diabetes in children using TREGS is, to the Company’s knowledge, the most advanced in clinical development. 
Origins of the Issuer and advancement of the projects: Work on the use of TREGS in the treatment of type 1 diabetes began as early as 2006 at the Medical University of Gdańsk and was conducted, among others, by the founders and key shareholders of the Company: Professor Piotr Trzonkowski, PhD; Professor Małgorzata Myśliwiec, PhD; and Professor Natalia Marek-Trzonkowska, PhD. The research conducted in subsequent years demonstrated the effectiveness of the solutions developed, which led to the incorporation of the Issuer as a spin-off from the Medical University of Gdańsk with the mission of conducting further stages of clinical research, developing new therapies and commercialising the solutions. As at the Prospectus Date, the Company continues to cooperate with the Medical University of Gdańsk in the development of the TREGS therapy. The Issuer has also established scientific cooperation with the University of Gdańsk. The Company’s founders, who have been working on the application of TREGS in the treatment of autoimmune diseases for 15 years, still belong to the Company’s core team which consists of approximately 20 people and will eventually number approximately 40 people after the launch of a new laboratory and preparation for subsequent phases of clinical trials. The Issuer is in the process of implementing an investment aimed at creating a modern research and development centre designed to develop and apply the TREG method in innovative therapies for autoimmune diseases. The Company is currently implementing two major groups of research and development projects at various stages of advancement (therapy of type 1 diabetes in children and multiple sclerosis) which provide a platform for the development of effective and innovative therapies for various autoimmune diseases as well as a project to develop the Treg 2.0 platform. Two phases of clinical research have been completed for therapy of type 1 diabetes in children. The Company is currently preparing for complementary Phase II/III trials in accordance with the EMA guidance provided in Scientific Advice. In addition, the Company is preparing a Phase I/II clinical trial of type 1 diabetes in children in pre-diabetic form as well as a long-term safety analysis of TREGS therapy in patients participating in previous phases of trials. Phase I clinical trials of multiple sclerosis therapy have been completed. The Company is preparing to conduct Phase I/IIa clinical trials for primary progressive multiple sclerosis and relapsing-remitting multiple sclerosis.

Public offering
The final number of shares offered in the Offering and the final number of shares offered to Individual Investors and Institutional Investors were determined on 26 October 2021. 
The final number of shares offered to Institutional Investors: 1,065,932 shares.
The final number of shares offered to Individual Investors: 266,482 shares.
The Final Price of Offered Shares was set at PLN 75.00. 

Allotment of shares
On 8 November 2021, the Management Board of the Issuer allotted 1,332,414 New Series M Shares offered by the Issuer in the Offering. 
The maximum number of New Shares was allotted in the Offering, including: 

• 1,486 Individual Investors were allotted 266,482 New Shares and the average reduction rate of Individual Investor subscriptions was 24.218%, 
• 26 Institutional Investors were allotted 1,065,932 New Shares. 

As the number of New Shares offered to Institutional Investors was equal to the number of New Shares subscribed for by the Institutional Investors, no reduction of subscriptions was made.
The value of the public offering is PLN 99,931,050.

Purpose of the issue
The purpose of the offering of the series M Shares is to raise funds necessary to pursue the key strategic objectives of the Company until Q1 2025. These objectives include research and development work related to the next phases of research on therapies for treating type 1 diabetes in children and therapy for multiple sclerosis, which the Company is working on, as well as the development of Treg 2.0.