REG - Allergy Therapeutics - Trading update for the year ended 30 June 2024

Allergy TherapeuticsAnnouncement

22/07/2024 07:15

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RNS Number : 1697X  Allergy Therapeutics PLC  22 July 2024

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company" or the "Group")

 

Trading update for the year ended 30 June 2024

 

-     Financial turnaround progressing with expected revenue growth in the
second half, marking the first period of half year growth since 2021

-     H2 revenues expected to be £21.6m (H2 2023: £21.2m) giving full
year revenues of £55.2m (2023: £59.6m)

-     Significant cost reductions made - overheads expected to be
significantly lower than prior year

-     Phase I/IIa VLP Peanut PROTECT trial remains on target with healthy
and peanut allergic patients receiving subcutaneous doses with no unexpected
safety signals

-     Pivotal Phase III Grass MATA MPL trial (G306) successfully meets
primary endpoint and positive discussions with regulators on pathway to
marketing authorization application (MAA) submission

-     Cash position of £12.9m at 30 June 2024 (2023: £14.8m) following
ongoing funding from amended shareholder loan facility

 

 

22 July 2024: Allergy Therapeutics plc (AIM: AGY), the integrated commercial
biotechnology company specialising in allergy vaccines, today announces its
trading update for the year ended 30 June 2024 ahead of its Full Year Results
to be announced in late-September.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:
"Our financial recovery comes alongside notable clinical progress, reflecting
the hard work and dedication of our team. Our commitments to enhance
manufacturing capabilities and improve supply chain efficiencies are paying
off. The Group's VLP Peanut vaccine candidate, with its promising safety and
efficacy, continues development at pace and brings hope to peanut allergy
patients. Meanwhile our Grass MATA MPL immunotherapy candidate, with its
ability to reduce grass allergy symptoms, is on the cusp of its first
regulatory filing. We are committed to advancing these innovative treatments
to improve the quality of life of people living with allergies."

 

Financials

 

Revenue for H2 is expected to have increased by 2% to £21.6m (H2 2023:
£21.2m), representing the first period of half year growth seen since 2021

 

Revenue for the year ended 30 June 2024 is expected to be 7% lower at
£55.2 million (2023: £59.6 million) as a consequence of the previously
reported impact of manufacturing capacity allocated to investigational
medicinal product batches for use in clinical trials, and the ongoing
programme of continuous improvement across the supply chain and quality
systems paving the way for increased capacity.

 

Effective cost controls implemented during the year have significantly reduced
the cost base of the Group. The operating loss pre-R&D is expected to be
lower than the prior year.

 

The unaudited cash balance at 30 June 2024 was £12.9 million (30 June
2023: £14.8 million) after drawing down £22.5 million from the amended
loan facility.

 

The Group expects that additional funding will be required from around late
August onwards for trading, working capital, capital expenditure and
continuing research and development programmes. The major shareholders have
provided sustained funding to the Group over the last 18 months, most recently
via the participation in the uncommitted £40m loan facility established in
December 2023 of which £22.5m has been drawn leaving £17.5m remaining. The
shareholders are aware of the Group funding needs over the next 12 months and
remain supportive of the business

Clinical Update

 

Grass MATA MPL Programme

 

Grass MATA MPL, the Group's short-course subcutaneous allergen-specific
immunotherapy (SCIT) candidate that aims to address the cause of symptoms of
allergic rhinoconjunctivitis due to grass pollen, continues its development
and plans are progressing, as previously communicated, to first register the
product with the Paul Ehrlich Institut (PEI) under the TAV programme in
Germany.

 

The pivotal Phase III G306 trial completed in Q4 2023 and met the primary
endpoint where the active treatment group demonstrated a highly statistically
significant reduction in Combined Symptom & Medication Score (CSMS) of
-20.3% (p≤0.0002) compared to placebo over the peak pollen season.

 

In addition, a strong, statistically significant induction of the protective
biomarker IgG4 was seen during the grass pollen season between active and
placebo (p ≤0.0001) and there was a statistically significant overall
improvement in the quality-of-life score, according to the Rhinoconjunctivitis
Quality of Life Questionnaire (RQLQ) (p ≤0.0003). No unexpected safety
events were observed with Grass MATA MPL 27,600 SU.

 

Positive regulatory discussions were held with the PEI early in 2024 regarding
the results of the pivotal G306 Phase III trial, as well as the data in
support of CMC requirements and the subsequent regulatory pathway to national
registration. During these meetings, key trial data from the pivotal G306
Phase III trial were shared, alongside supporting CMC data that the Group
plans to use as the basis for the proposed marketing authorisation application
(MAA). Feedback was constructive and the PEI confirmed that, subject to the
usual regulatory approval procedures and detailed data analysis, the Group may
proceed with an MAA. As previously announced, the Group intends to submit an
MAA to PEI in Q4 2024 and this remains on track.

 

The completion of the G309 and G306 field studies represents a significant
milestone in plans for registration in the US. Following an earlier successful
end of phase II meeting with the FDA, the subsequent studies were designed to
support a pathway forward to BLA in the US with both G309 and G306 studies
including US subjects and it is also planned to include US subjects in the
upcoming five-year long paediatric study (G308), which is expected to begin
later in 2024.

 

A specific requirement for the FDA will involve a further study, known as
G307, to meet the required total number of US subjects treated using the
product intended for registration and the Group is planning for meetings with
the FDA to agree a route forward.

 

VLP Peanut Programme

 

The clinical development for the Group's innovative, short-course peanut
allergy vaccine candidate, VLP Peanut, via subcutaneous injection is
progressing as planned.

 

The ongoing Phase I/IIa VLP Peanut PROTECT trial is evaluating the maximum
safe and tolerated dose of the Group's peanut allergy vaccine candidate and
includes assessment of biomarker efficacy in peanut allergic patients.

 

Patients who are allergic to peanuts had previously completed skin-prick
testing in the PROTECT trial and to date they have now completed three
incremental subcutaneous dose levels over two months with no safety signals
observed.

 

Healthy subjects in the PROTECT trial have received a 400-fold dose increase
of VLP Peanut, providing strong confidence that the VLP technology within the
vaccine candidate is safe and well tolerated at high cumulative doses. This is
essential for further clinical development of VLP Peanut as the trial's
external safety review committee agreed that the doses administered so far
have been safe and well tolerated and dose increments in next cohorts can
proceed as planned to similarly high doses in peanut allergic patients, to
establish the dose range to be considered for the upcoming Phase IIb study.

 

The PROTECT trial continues to run as planned and data observed thus far
supports the hypo-allergic safety profile of VLP Peanut which is a key step in
realising its potential as a transformative option for peanut allergy
sufferers. Efficacy suggestive biomarker analysis is expected to be available
in Q4 2024.

 

 

This announcement contains inside information for the purposes of the UK
Market Abuse Regulations.

 

-  ENDS -

For further information, please contact:

 

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

+44 (0)1903 845 820

 

Cavendish Capital Markets Limited (Nominated Adviser and Broker)

Geoff Nash /Giles Balleny/Seamus Fricker / Rory Sale

Nigel Birks/Tamar Cranford Smith - Sales

+44 (0)20 7220 0500

 

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

+44 (0)20 3709 5700

allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

About Allergy Therapeutics

 

Allergy Therapeutics is an international commercial biotechnology company,
headquartered in the UK, focussed on the treatment and diagnosis of allergic
disorders, including aluminium free immunotherapy vaccines that have the
potential to cure disease. The Group sells proprietary and third-party
products from its subsidiaries in nine major European countries and via
distribution agreements in an additional ten countries. Its broad pipeline of
products in clinical development includes vaccines for grass, tree, house dust
mite and peanut. For more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com) .

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