REG - Poolbeg Pharma PLC - Pre-IND Meeting with the FDA for POLB 001

Poolbeg PharmaAnnouncement

26/05/2026 07:00

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RNS Number : 5748F  Poolbeg Pharma PLC  26 May 2026

 

Poolbeg Pharma plc

 

Pre-IND Meeting with the FDA for POLB 001

 

FDA feedback supports Poolbeg's proposed development pathway for POLB 001,
providing further clarity for ongoing partnering discussions

 

26 May 2026- Poolbeg Pharma
(https://protect.checkpoint.com/v2/r02/___https:/www.poolbegpharma.com/___.YXAxZTpzaG9yZWNhcDpjOm86MmI2OWFmYmU2ZGVmOGFmMjRjZjIwYTZhMWI0YzUzOTI6Nzo2M2Q2OjY1YTk2ZTY1YWRmZjg0ODYzZmE1YmExZmY4OTc5NjgwNzMxMTZlYjlhZmI1YzRhMzdhZjYyODA5YWE1NDFkNTU6cDpGOk4)
 (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical
company with a core focus on transforming the cancer immunotherapy field,
announces the positive outcome of a pre-Investigational New Drug (IND) meeting
with the U.S. Food and Drug Administration ("FDA") for POLB 001, the Company's
lead asset, a potential preventative therapy for cancer immunotherapy-induced
Cytokine Release Syndrome ("CRS").

 

In a pre-IND meeting the FDA provides feedback on the clinical development
strategy for drug candidates. This allows pharma companies to align their
strategy with the FDA's requirements. The FDA feedback received by Poolbeg was
broadly aligned with key aspects of the Company's envisioned development
pathway for POLB 001. Poolbeg believes that there is an attractive route to
market for POLB 001 and that this feedback re-affirms the appeal of the
programme to potential partners.

 

The overall clinical development strategy was discussed and there was
alignment on the proposed primary endpoint for a future Phase 3 clinical
trial. Alignment with regulatory authorities on POLB 001's development pathway
is an important milestone and provides potential partners with a higher degree
of certainty of the route to market, thereby further de-risking the programme.

 

Bruno Speder, VP of Regulatory Affairs at Poolbeg Pharma, said: "We received
constructive feedback from the FDA and achieved broad alignment on several
important aspects of the development pathway for POLB 001. We believe that
POLB 001 has the potential to address a critical unmet need in cancer
immunotherapy-induced CRS, and this feedback provides greater clarity as we
continue to advance the programme and supports our ongoing partnering
discussions."

 

Nothing in this announcement is intended to imply FDA approval, nor does it
represent FDA opinion on the efficacy, safety or approvability of the
programme. The FDA meeting was intended only to obtain regulatory guidance on
specific aspects of the proposed development and testing pathway.

 

Enquiries

 Poolbeg Pharma Plc                                           +44 (0) 207 183 1499

ir@poolbegpharma.com (mailto:ir@poolbegpharma.com)
 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 Cavendish Capital Markets Ltd (NOMAD & Joint Broker)         +44 (0) 207 220 0500
 Geoff Nash, Trisyia Jamaludin (Corporate Finance)
 Nigel Birks (Life Science Specialist Sales)
 Harriet Ward (ECM)

 Shore Capital Stockbrokers Ltd (Joint Broker)                +44 (0) 207 408 4090
 David Coaten, Harry Davies-Ball (Corporate Advisory)
 Malachy McEntyre (Corporate Broking)

 J&E Davy (Joint Broker)                                      +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Optimum Strategic Communications                             +44 (0) 208 078 4357
 Nick Bastin, Katie Flint, Elena Bates
poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

 

About Poolbeg Pharma plc

Poolbeg Pharma plc (AIM: POLB) is a clinical-stage
biopharmaceutical company with a core focus on transforming the cancer
immunotherapy field. The Company's lead asset, POLB 001, has the potential to
expand administration of cancer immunotherapies from centralised specialist
cancer centres into community hospitals by making the treatments safer through
the prevention of the life-threatening side effect, Cytokine Release Syndrome
(CRS). As such, POLB 001 could increase the number of patients that can
receive these life-saving treatments, thereby increasing the market
opportunity. Poolbeg is also advancing the development of a patient-friendly
therapy for obesity with an oral encapsulated GLP-1, offering a differentiated
approach within one of the world's largest markets. With multiple near-term
clinical value inflection points, and an experienced team with a proven track
record, Poolbeg is focussed on partnering its high value programmes that are
targeting large markets and addressing critical unmet medical needs.

 

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Forward-Looking Statements

This announcement may contain forward-looking statements and the words
"expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast",
"project" and similar expressions (or their negative) identify certain of
these forward-looking statements. The forward-looking statements in this
announcement are based on numerous assumptions and Poolbeg's present and
future business strategies and the environment in which Poolbeg expects to
operate in the future. Forward-looking statements involve inherent known and
unknown risks, uncertainties and contingencies because they relate to events
and depend on circumstances that may or may not occur in the future and may
cause the actual results, performance or achievements to be materially
different from those expressed or implied by such forward-looking statements.
These statements are not guarantees of future performance or the ability to
identify and consummate investments. Many of these risks and uncertainties
relate to factors that are beyond Poolbeg's ability to control or estimate
precisely, such as future market conditions, currency fluctuations, the
behaviour of other market participants, the outcome of clinical trials, the
actions of regulators and other factors such as Poolbeg's ability to obtain
financing, changes in the political, social and regulatory framework in which
Poolbeg operates or in economic, technological or consumer trends or
conditions. Past performance should not be taken as an indication or guarantee
of future results, and no representation or warranty, express or implied, is
made regarding future performance. No person is under any obligation to update
or keep current the information contained in this announcement or to provide
the recipient of it with access to any additional relevant information.

 

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