PolTREG appoints Dan Shelly as Chief Business Development Officer

Gdansk, Poland – 21 February 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing cell therapies for a wide range of autoimmune diseases, announces today it has appointed Prof. Daniel Shelly, PhD, MBA, into the role of Chief Business Development Officer, to help PolTREG build the strategic, commercial, research and pharmaceutical partnerships that will enable the company to successfully commercialise its strong pipeline of cell therapies for diseases such as Type-1 Diabetes (T1D), Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS).

“I am elated we were able to attract Dan to help us deliver the promise of Treg cell therapies for a wide range of autoimmune diseases. PolTREG has the most comprehensive pipeline of cell therapies for autoimmune diseases, including Type-1 Diabetes and Multiple Sclerosis, and Dan’s arrival will enable us to continue to deliver the milestones that will bring our lead assets closer to market,” said Prof. Piotr Trzonkowski, Chief Executive Officer of PolTREG.

Dr Shelly is an astute veteran of the life science industry, with a deep understanding of biology and the Treg cell therapies that PolTREG is developing. He has a proven track record of closing business development deals for a wide range of biotech companies, including most recently several early-stage evaluation deals for Prescient Therapeutics Ltd., a clinical stage oncology company developing personalised medicine approaches to cancer, using CAR-T technologies. He was Director of Global Business Development and Strategic Partnerships for the global non-profit PATH, where he was the Co-Lead for the COVID-19 task force. He is an adjunct associate professor at the University of Cincinnati, where he teaches biologics discovery, pharmaco-economics and biotech business, publishes in scientific journals, and is a frequently invited speaker and thought leader at international cell therapy conferences. Dr Shelly has a comprehensive understanding of the clinical development pathway, with direct experience of regulatory submissions, and is skilled in clinical assetvaluation and due diligence.

PolTREG boasts the most advanced pipeline for Treg cell therapies in autoimmune disease, with its lead candidate, PTG-007, in mid-stage clinical studies in T1D and MS. In addition, the company expects to start First-in-Human clinical trials of its CAR-Tregs for two neurodegenerative diseases - MS and ALS – in early 2025.

Complementing PolTREG’s innovative clinical pipeline is the recent opening of one of Europe’s largest CGMP cell therapy manufacturing facilities. The facility, one of the most advanced of its kind, will have over 2,100 sqm of laboratory space, including 15 operational production lines, a capacity that can be significantly further expanded. The facility already can deliver life-improving cell therapies anywhere in Europe within 24 hours post production.

PolTREG was the first company in the world to administer Treg therapies to patients and the first to start receiving revenues from its lead product. So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland.

About PolTREG
PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. The company will launch Phase 2 trials for PTG-007 to treat Multiple Sclerosis (MS) in the second half of 2024, for RRMS and PPMS. PolTREG also has engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical stage. PolTREG  has completed four clinical trials with more than 100 patients treated with Tregs.

For more information please visit www.poltreg.com.

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Important information
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

Attachments

• 20240216 PolTREG PR Dan Shelly - approved
• Daniel Shelly

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