Allergy Therapeutics
plc
("Allergy
Therapeutics", the "Group" or the "Company")
Half-Year Trading Update
2024
14 February 2024: Allergy
Therapeutics plc (AIM: AGY), the fully integrated commercial
biotechnology company specialising in allergy vaccines, is today
providing a trading update for the six months ended
31 December 2023 ahead of its Half Year Results which will be
announced in March 2024.
Financials
The Group expects revenue for the
six months ended 31 December 2023 to be £33.6 million
(2022: £39.9 million) representing a reduction of 16% on a
reported and constant* currency basis. This decrease in revenue is
attributed to the allocation of manufacturing capacity to
investigational medicinal product batches for use in clinical
trials, as previously reported. In the second half of the financial
year, sales are expected to be slightly higher than the previous
year. Consequently, as previously announced, overall sales for the
full year ending on 30 June 2024 are expected to be slightly lower
than the corresponding period ending 30 June 2023. The
programme of continuous improvement across the
supply chain and quality systems paving the way for increased
capacity is ongoing and is a multi-year project.
The cash balance as of
31 December 2023 was £13.5 million (30 June
2023: £14.8 million). Pursuant to the amendment to the
existing secured loan facility announced on 27 December 2023,
subsequent to the period end the Company has drawn down £4 million
from the £7.5 million committed facility ("Committed Facility")
with a further undrawn committed facility of £3.5 million remaining
as at 13 February 2024. The secured loan facility also includes an
uncommitted amount of £32.5 million. The Company currently
anticipates that further funding will be required (in addition to
the balance of the Committed Facility") during Q4 of the 2024
financial year.
Research and development pipeline
Grass MATA MPL
The Group's pivotal G306 Phase III
trial of Grass MATA MPL, its short-course subcutaneous
allergen-specific immunotherapy (SCIT) candidate, has successfully
met its primary endpoint, as previously announced on 14 November
2023. The trial aimed to address the underlying cause of symptoms
associated with allergic rhinoconjunctivitis due to grass pollen.
Further analysis of the dataset showed highly significant secondary
efficacy endpoints, with an acceptable safety and tolerability
profile as announced on 13 December 2023.
The first scientific advisory
meeting with regulators is anticipated to occur in late Q1 2024,
where discussions will confirm the pathway forward for potential
progression to the marketing authorisation application
process.
VLP Peanut
As previously communicated, the
Group completed dosing in healthy volunteers in the first two
cohorts of the Phase I PROTECT trial ("PROTECT trial") for its
novel virus-like particle (VLP)-based peanut allergy vaccine
candidate ("VLP Peanut") in September 2023. The Group has recently
submitted the first PROTECT results of the skin-prick testing part
for publication in The Journal of Allergy and Clinical
Immunology.
Following the 25-fold increase in
dose-escalation that was tolerated in the first part of the VLP101
study, and with the external safety review committee approval to
proceed to subcutaneous dose escalation in peanut allergic
subjects, the Group is actively recruiting for the phase I/IIa
stage of the study. There are a total of four cohorts with eight
patients within each. This part of the study includes analysis of
various biomarkers, one of which is the study of the activation of
basophils via the basophil activation test (BAT). Key researchers
have recently confirmed that BAT is a powerful diagnostic tool to
predict allergic status that is closely correlated to food
challenge outcomes [1]. This work is being conducted in
collaboration with the Johns Hopkins University Dermatology,
Allergy and Clinical Immunology Reference Laboratory supported by
the Johns Hopkins allergy laboratory in Baltimore with BA. Other
efficacy markers are expected to provide evidence of
preliminary efficacy during the second part of the VLP101 PROTECT
study, prior to embarking on the subsequent Phase IIb stages of the
clinical programme.
No safety signal has been observed
in healthy subjects to date and the
complete results of the PROTECT trial are anticipated to be
available later in 2024.
*Constant currency uses prior year
weighted average exchange rates to translate current year foreign
currency denominated revenue to give a year-on-year comparison
excluding the effects of foreign exchange movements
1.
Santos AF, Bergmann M, Brough HA, et al. Basophil Activation Test
Reduces Oral Food Challenges to Nuts and Sesame. J Allergy Clin
Immunol Pract. 2021;9(5):2016-2027.e6.
doi:10.1016/j.jaip.2020.12.039
This announcement contains inside
information for the purposes of the UK Market Abuse
Regulations.
- ENDS
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For
further information, please contact:
Allergy Therapeutics
+44 (0)1903 845 820
Manuel Llobet, Chief Executive
Officer
Shaun Furlong, Chief Financial
Officer
Panmure Gordon (Nominated Adviser and
Broker)
+44 (0)20 7886 2500
Freddy Crossley, Emma Earl,
Corporate Finance
Rupert Dearden, Corporate
Broking
ICR
Consilium
+44 (0)20 3709 5700
Mary-Jane Elliott / David Daley /
Davide Salvi
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.