Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company" or the "Group")

Allergy Therapeutics granted marketing authorisation for Grassmuno^® (Grass MATA MPL) by the German regulatory authority, the Paul Ehrlich Institut

-     Regulatory approval in Germany follows submission of comprehensive evidence package of quality, safety and clinical efficacy supporting innovative subcutaneous immunotherapy (SCIT) designed to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen

-     First subcutaneous grass-pollen immunotherapy approved under Germany's TAV programme

-     Commercialisation in Germany anticipated Q1 2026

-     German seasonal allergy market is projected to reach ~US$1 billion by 2030¹

-     Company continues its expansion strategy for the product with potential for regulatory submissions across other major global markets

16 December 2025: Allergy Therapeutics plc (AIM: AGY), the integrated commercial biotechnology company specialising in allergy immunotherapies, today announces that the Paul Ehrlich Institut (PEI) has granted a marketing authorisation in Germany for the Group's subcutaneous grass pollen allergen immunotherapy, Grass MATA MPL, which will be commercialised in the German market as Grassmuno^®.

Grassmuno is a subcutaneous allergen immunotherapy containing a unique mixture of allergen extracts from grass pollen and the Group's novel adjuvant system, monophosphoryl lipid-A (MPL^®) and the biodegradable depot adjuvant microcrystalline tyrosine (MCT), to increase the immunotherapy's immunogenic effect. It is indicated for the treatment of moderate to severe allergic symptoms in adults caused by pollen from grasses (hay fever), such as running nose (rhinitis), allergic conjunctivitis (rhinoconjunctivitis), without asthma or with asthma that is well controlled. Treatment is administered before the grass-pollen season as a six-injection pre-seasonal course.

The approval marks the first subcutaneous grass-pollen immunotherapy to be authorised by the PEI through its TAV (Therapieallergene-Verordnung) framework and follows the submission of a comprehensive evidence package of quality, safety and clinical efficacy including the Group's pivotal Phase III G306 trial in adults. In that trial, the immunotherapy demonstrated a highly statistically significant and clinically relevant reduction in the Combined Symptom & Medication Score (CSMS) compared to placebo over the peak pollen season.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The regulatory approval of this state-of-the-art short-course aluminium-free immunotherapy is a defining moment for Allergy Therapeutics and for the future of allergy immunotherapy in Germany. Grass pollen, a common cause of seasonal allergy, significantly impacts the lives of many people and new treatment options are desperately needed. Grassmuno offers an effective, convenient treatment option for people living with a grass-pollen allergy, and its authorisation under the TAV regulation validates our clinical excellence and commitment to quality. It also validates our MATA MPL platform concept and establishes a strong foundation for our future expansion strategy for this innovative and disruptive immunotherapy with allergens such as birch and ragweed across other major global markets."

Grass pollen is a key segment within the German seasonal allergy market, which is projected to reach ~US$1 billion by 2030¹. Grassmuno is expected to be a major driver of the Group's business in Germany, its largest market, as a regulatory-approved, short-course treatment approach that can be completed before the allergy season begins. This offers the potential for people living with a grass pollen allergy to achieve protection without the burden of months-long treatment schedules.

In November 2024 the Group commenced a Phase III trial (G308) to evaluate the short- and long-term efficacy and safety of Grass MATA MPL in a paediatric population. That trial is the first long-term SCIT trial in a paediatric population and complements Allergy Therapeutics' previous studies in adults, furthering its comprehensive development strategy for the immunotherapy across different age groups.

Allergy Therapeutics continues to explore the potential for additional registration opportunities in other major global markets, following engagement with authorities regarding local regulatory requirements.

-  ENDS -

References

1.   Internal company projections

About Grass MATA MPL

Grass MATA MPL is a subcutaneous allergen immunotherapy to treat moderate to severe allergic symptoms in adults caused by pollen from grasses, such as running nose (rhinitis), allergic conjunctivitis (rhinoconjunctivitis), without asthma or with asthma that is well controlled. It is given before the start of the pollen season.

The immunotherapy contains an extract of 13 grass pollens modified with glutaraldehyde to form allergoids that reduces 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 microcrystalline tyrosine (MCT) 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.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation ("MAR") EU no.596/2014. Upon the publication of this announcement via Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain. 

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

Nigel Birks - Life Science Specialist Sales

+44 (0)20 7220 0500

ICR Healthcare

Mary-Jane Elliott / David Daley / Davide Salvi

+44 (0)20 3709 5700

[email protected]

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 immunotherapies 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. For more information, please see www.allergytherapeutics.com.