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
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.