REG - Allergy Therapeutics - Half-Year Trading Update 2024

Allergy TherapeuticsAnnouncement

14/02/2024 07:00

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RNS Number : 0420D  Allergy Therapeutics PLC  14 February 2024

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 -

 

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
(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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