Allergy Thera. Regulatory News (AGY)

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

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.