Poolbeg Pharma PLC (AIM:POLB) Results for the year ended 31 December 2022

Significant milestones reached, well capitalised and positioned for future growth

London, UK 30 March 2023 – Poolbeg Pharma Plc (AIM: POLB, OTCQB: POLBF “Poolbeg” or the “Company”) a leading biopharmaceutical company focusing on infectious and prevalent diseases with a high unmet medical need, is pleased to announce its audited results for the year ended 31 December 2022.

Financial & Corporate Highlights

– Well capitalised with a cash balance of £16.2m at year end

– Poolbeg-led consortium awarded €2.3m in non-dilutive funding to progress its Oral Vaccine Platform

– Select experienced hires, bolstering the Company’s capabilities in core areas such as business development and clinical operations

Operational Highlights

· POLB 001 – potential blockbuster p38 MAP Kinase inhibitor for the treatment of severe Influenza and other acute inflammatory conditions

– Successfully completed the bacterial lipopolysaccharide (“LPS”) human challenge trial in 2022

– Positive results from the trial were published earlier this month. POLB 001 was shown to be safe and well tolerated and had a potent effect on systemic and localised inflammatory response in a dose dependent manner. This significant milestone demonstrates POLB 001’s expected utility in severe influenza and supports its continued development in other acute inflammatory conditions

– Poolbeg continues to evaluate POLB 001’s potential in additional indications to fully unlock the potential value of the molecule and strengthen Poolbeg’s position for partnering and out-licensing

· POLB 001 – Oncology

– Strategically expanded POLB 001 in January 2023 as a potential treatment option for Cytokine Release Syndrome (CRS), a side-effect associated with CAR T cell therapy. Clinical trial enabling activities are underway with trial initiation in CAR T cell patients expected in H1 2024

· Artificial Intelligence (“AI”) Programmes – a nalysis of unique disease progression data derived from human challenge trial samples

– Respiratory Syncytial Virus (“RSV”) AI programme with partner OneThree Biotech. Poolbeg embarked on a world first programme in February 2022 which yielded multiple novel RSV drug targets in November 2022. Following the discovery of these drug targets, the collaboration successfully identified a number of promising RSV drug candidates which can now be rapidly brought forward to lab-based validation

– Influenza AI programme with leading AI company, CytoReason, commenced in March 2022 and hit a major milestone in November 2022 as the construction of the computational artificial intelligence influenza disease model was completed

· Continued expansion and diversification of the pipeline

– POLB 002 – in-licensed an intra-nasally administered, RNA-based immunotherapy for pan-respiratory virus infections

– POLB 003 – in-licensed late-preclinical stage intra-muscular vaccine candidate for the prevention of Melioidosis, a predominantly tropical / subtropical disease with a high mortality rate and no approved vaccine available

– The Company continues to evaluate five other bacterial vaccine candidatesbeing developed at University College Dublin (“UCD”)under an ongoing option agreement

– Oral Vaccine Platform – licensed microencapsulation and nanoencapsulation technology aimed at triggering ‘mucosal immunity’ by delivering oral vaccines to the gut, preventing infections from taking hold in the body by counteracting them at the point of entry, both reducing transmission and preventing serious disease

– Oral Delivery of Metabolic Disease Treatments – licensed patented encapsulation technologies in metabolic syndrome related diseases, including obesity, pre-diabetes and diabetes

Jeremy Skillington, PhD, Chief Executive Officer, Poolbeg Pharma, said: “As we reflect on Poolbeg’s accomplishments in 2022, we are delighted with the progress we have made in our pipeline development, clinical programmes, and our AI drug discovery programmes. Our strong cash position, coupled with the excellent data achieved in our LPS human challenge trial for POLB 001, position us well for 2023 as we work towards our first partnering transaction. We remain committed to disciplined capital allocation, cost-effective R&D, and strategic partnerships, as we continue to pursue our goal of becoming a one-stop-shop for pharma and biotechs seeking products to in-license.”

Investor presentation

The Company will provide a live presentation relating to the results for the year ended 31 December 2022 via the Investor Meet Company platform on Thursday 30 March 2023 at 10:00 BST.

The presentation is open to analysts and all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma here . Those who already follow Poolbeg Pharma on the Investor Meet Company platform will automatically be invited.

The Company’s Annual Report and Accounts for the year ended 31 December 2022 will be posted to shareholders in due course together with the notice of the 2023 Annual General Meeting, and will be available on the Company’s website: www.poolbegpharma.com/investors/documents/

– Ends –


Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

+44 (0) 207 183 1499

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