Poolbeg Pharma (POLB ), a clinical stage infectious disease company, announced audited results for the year ended 31 December 2022 (FY22).
Poolbeg advanced development of its flagship POLB 001 candidate for severe influenza and other acute inflammatory conditions. Poolbeg successfully completed an LPS human challenge trial for POLB 001 during the period, and published positive results from the trial earlier this month.
Data from the LPS human challenge trial indicated POLB 001 was "safe and well tolerated and had a potent effect in systemic and localised inflammatory response in a dose dependent manner."
Poolbeg also expanded POLB 001 into oncology 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.
Poolbeg's AI initiatives made news last year. In partnership with OneThree Biotech, Poolbeg identified several RSV drug candidates using AI analysis in November 2022, which are being brought forward to lab-based validation.
And in partnership with CytoReason commenced in March 2022, Poolbeg announced the construction of a computational AI influenza disease model.
The company's development pipeline also includes POLB 002 - an RNA-based immunotherapy for pan-respiratory virus infections, and POLB 003 - a late-preclinical stage intra-muscular vaccine candidate for the prevention of Melioidosis. Five other bacterial vaccine candidates are also being developed at University College Dublin under an ongoing option agreement.
In November 2022, a Poolbeg-led consortium was awarded €2.3m to progress Poolbeg's Oral Vaccine Platform, helping Poolbeg finish the year with a cash balance of £16.2m. Jeremy Skillington, PhD, CEO, commented on the results:
"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."
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Poolbeg entered FY23 with strong momentum after expanding its pipeline significantly and hitting major development milestones in FY22. Post-period, Poolbeg announced a successful LPS human challenge trial for its flagship POLB 001 candidate, which confirmed POLB 001 is highly effective in inhibiting hyperinflammatory response that can be life threatening in severe influenza and other acute inflammatory conditions.
POLB 001 is a potential blockbuster small molecule immunomodulator being developed to address the unmet medical need arising from severe influenza and other inflammatory conditions. Unlike other influenza treatments, POLB 001 targets the host's immune response rather than the viral infection itself. Due to its mode of action, it is strain agnostic and unaffected by seasonal variants. Furthermore, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks.
Poolbeg is focused on identifying additional indications for POLB 001's to fully unlock the molecule's potential and strengthen Poolbeg's position for partnering and out-licensing. To this end. Poolbeg announced in January 2023, an expansion of POLB 001 into oncology, as a potential treatment option for CRS that is experienced by up to 95% of cancer patients receiving CAR T cell therapy.
Clinical trial enabling activities are underway to progress towards trial initiation in CAR T cell patients in 2024.
Poolbeg has been developing POLB 001 in accordance with its capital-light business model. Poolbeg aims to develop and bring products through to early human proof of concept in the clinic, then partner with large pharma and biotech companies that continue the pipeline to production and distribution. Thus, Poolbeg profits from the relatively inexpensive human trial process, now enhanced with their partners' AI analysis, and then exits at the scale-up stage.
The company is currently in discussions with potential partners for POLB 001, with an agreement likely to be signed in 2023.
Beyond POLB 001, Poolbeg made significant progress in advancing its POLB 002 and POLB 003 candidates, as well as its AI initiatives through partnerships with CytoReason and OneThreeBiotech.
Poolbeg is targeting initial results from its collaboration with CytoReason in Q2 2023, as well as results from its GLP-1 oral vaccine trial by Q4 2023. The partnership with OneThreeBiotech successfully identified multiple RSV drug candidates using AI analysis, which are being brought forward to lab-based validation.
In the wake Covid-19, global biopharma has refocused on developing vaccines and treatments targeting infectious diseases, which has become one of the fastest growing pharma markets, expected to exceed US$250bn by 2025.
Poolbeg is well-positioned and well-funded to address this market with a cash balance of £16.2m at year end. The loss for the year amounted to £4.7m and comprises R&D expenses of £2.2m, administrative expenses of £3.1m, and other income and tax rebates of £0.6m. As Poolbeg nears the finish line on several disruptive projects, its heavy investment in R&D and patented IP is expected to generate profits in the near term. Markets agree as POLB stock is now up 84% in the last 6 months. POLB shares were up 5.8% on today's report.
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