Allergy Thera. Regulatory News (AGY)

Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

Positive primary and secondary endpoints of G306 pivotal Phase III trial investigatingGrass MATA MPL are highly consistent

- Highly significant secondary efficacy endpoints with an acceptable safety and tolerability profile observed for Grass MATA MPL

- Scientific advice meetings with relevant health authorities anticipated in Q1 2024 to discuss plans for progression to a marketing authorisation application

13 December 2023 Allergy Therapeutics plc (AIM: AGY), the integrated commercial biotechnology company specialising in allergy vaccines, today provides an update on the data analysis of its pivotal G306 Phase III trial of 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.

As previously communicated, the active treatment group demonstrated a highly statistically significant reduction in Combined Symptom & Medication Score (CSMS) (p?0.0024) compared to placebo over the peak pollen season. This allowed the Group to stop the study for success and no second season cohort was required.

Further analysis of the dataset shows:

· Statistical significance was also seen in the eDiary secondary endpoints, including CSMS during the entire grass pollen season, and daily medication and daily symptom scores

· A strong, statistically significant induction of the protective biomarker IgG4 was seen during the grass pollen season between active and placebo (p ?0.0001)

· 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

The large dataset, including primary and secondary endpoints, is being collated for use in regulatory discussions on the route to market authorisation application. The Group is pleased that the secondary endpoints strongly align, and all data analysed demonstrates the beneficial effect of the Grass MATA MPL 27,600 SU product.

The first scientific advice meeting with regulators is anticipated to occur in late Q1 2024, where discussions will lay out a pathway forward to permit progression to the marketing authorisation application process.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are very pleased that the primary and secondary endpoints from this trial strongly align, and all data analysed demonstrate the beneficial effect of our Grass MATA MPL product. These data, alongside the results from our earlier G309 field study, provide a strong, significant and consistent data package for our discussions with relevant health authorities."

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

- ENDS -

For further information, please contact:

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

+44 (0)1903 845 820

Panmure Gordon

Emma Earl, Mark Rogers, Freddy Crossley, Corporate Finance

Rupert Dearden, Corporate Broking

+44 (0) 20 7886 2500

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

+44 20 3709 5700

allergytherapeutics@consilium-comms.com

Notes for editors:

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.

About Allergic Rhinitis

Allergic rhinitis and/or rhinoconjunctivitis is a type I allergic disease to common aeroallergens such as pollen, mould spores and house dust mite residue. Seasonal allergic rhinitis is most commonly caused by allergy to pollen from tree, grasses or weeds, while perennial allergic rhinitis is most commonly associated with allergy to dust mite residue, mould spores or animal dander2

About Grass MATA MPL

Grass MATA MPL is being developed as a pre-seasonal subcutaneous immunotherapy product for the treatment of allergic rhinitis and/or rhinoconjunctivitis.

Grass MATA MPL contains an extract of 13 grass pollens modified with glutaraldehyde (allergoid) to reduce the reactivity with immunoglobulin E (IgE) antibodies without a reduction in other important immunological properties, such as T-cell reactivity. The allergoid is adsorbed to L-tyrosine as a depot adjuvant system formulation. Monophosphoryl lipid-A (MPL), is included as an adjuvant to increase the immunogenic effect of the immunotherapy and to enhance the switch from an allergen specific helper T-cell Type 2 (Th2) to helper T-cell Type 1 (Th1) like immune response.

More information about the Phase III G306 Grass MATA MPL trial can be found on ClinicalTrials.gov under the identifier NCT05540717.