Trading update for the year ended 30 June 2024

Allergy Therapeutics PLC

22 July 2024

 

Allergy Therapeutics plc

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

Trading update for the year ended 30 June 2024

-     Financial turnaround progressing with expected revenue growth in the second half, marking the first period of half year growth since 2021

-     H2 revenues expected to be £21.6m (H2 2023: £21.2m) giving full year revenues of £55.2m (2023: £59.6m)

-     Significant cost reductions made - overheads expected to be significantly lower than prior year

-     Phase I/IIa VLP Peanut PROTECT trial remains on target with healthy and peanut allergic patients receiving subcutaneous doses with no unexpected safety signals 

-     Pivotal Phase III Grass MATA MPL trial (G306) successfully meets primary endpoint and positive discussions with regulators on pathway to marketing authorization application (MAA) submission

-     Cash position of £12.9m at 30 June 2024 (2023: £14.8m) following ongoing funding from amended shareholder loan facility

22 July 2024: Allergy Therapeutics plc (AIM: AGY), the integrated commercial biotechnology company specialising in allergy vaccines, today announces its trading update for the year ended 30 June 2024 ahead of its Full Year Results to be announced in late-September.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "Our financial recovery comes alongside notable clinical progress, reflecting the hard work and dedication of our team. Our commitments to enhance manufacturing capabilities and improve supply chain efficiencies are paying off. The Group's VLP Peanut vaccine candidate, with its promising safety and efficacy, continues development at pace and brings hope to peanut allergy patients. Meanwhile our Grass MATA MPL immunotherapy candidate, with its ability to reduce grass allergy symptoms, is on the cusp of its first regulatory filing. We are committed to advancing these innovative treatments to improve the quality of life of people living with allergies."

Financials

Revenue for H2 is expected to have increased by 2% to £21.6m (H2 2023: £21.2m), representing the first period of half year growth seen since 2021

Revenue for the year ended 30 June 2024 is expected to be 7% lower at £55.2 million (2023: £59.6 million) as a consequence of the previously reported impact of manufacturing capacity allocated to investigational medicinal product batches for use in clinical trials, and the ongoing programme of continuous improvement across the supply chain and quality systems paving the way for increased capacity.

Effective cost controls implemented during the year have significantly reduced the cost base of the Group. The operating loss pre-R&D is expected to be lower than the prior year.

The unaudited cash balance at 30 June 2024 was £12.9 million (30 June 2023: £14.8 million) after drawing down £22.5 million from the amended loan facility.

The Group expects that additional funding will be required from around late August onwards for trading, working capital, capital expenditure and continuing research and development programmes. The major shareholders have provided sustained funding to the Group over the last 18 months, most recently via the participation in the uncommitted £40m loan facility established in December 2023 of which £22.5m has been drawn leaving £17.5m remaining. The shareholders are aware of the Group funding needs over the next 12 months and remain supportive of the business

Clinical Update

Grass MATA MPL Programme

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, continues its development and plans are progressing, as previously communicated, to first register the product with the Paul Ehrlich Institut (PEI) under the TAV programme in Germany.

The pivotal Phase III G306 trial completed in Q4 2023 and met the primary endpoint where the active treatment group demonstrated a highly statistically significant reduction in Combined Symptom & Medication Score (CSMS) of -20.3% (p≤0.0002) compared to placebo over the peak pollen season.

In addition, a strong, statistically significant induction of the protective biomarker IgG4 was seen during the grass pollen season between active and placebo (p ≤0.0001) and 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.

Positive regulatory discussions were held with the PEI early in 2024 regarding the results of the pivotal G306 Phase III trial, as well as the data in support of CMC requirements and the subsequent regulatory pathway to national registration. During these meetings, key trial data from the pivotal G306 Phase III trial were shared, alongside supporting CMC data that the Group plans to use as the basis for the proposed marketing authorisation application (MAA). Feedback was constructive and the PEI confirmed that, subject to the usual regulatory approval procedures and detailed data analysis, the Group may proceed with an MAA. As previously announced, the Group intends to submit an MAA to PEI in Q4 2024 and this remains on track.

The completion of the G309 and G306 field studies represents a significant milestone in plans for registration in the US. Following an earlier successful end of phase II meeting with the FDA, the subsequent studies were designed to support a pathway forward to BLA in the US with both G309 and G306 studies including US subjects and it is also planned to include US subjects in the upcoming five-year long paediatric study (G308), which is expected to begin later in 2024.

A specific requirement for the FDA will involve a further study, known as G307, to meet the required total number of US subjects treated using the product intended for registration and the Group is planning for meetings with the FDA to agree a route forward.

VLP Peanut Programme

The clinical development for the Group's innovative, short-course peanut allergy vaccine candidate, VLP Peanut, via subcutaneous injection is progressing as planned.

The ongoing Phase I/IIa VLP Peanut PROTECT trial is evaluating the maximum safe and tolerated dose of the Group's peanut allergy vaccine candidate and includes assessment of biomarker efficacy in peanut allergic patients.

Patients who are allergic to peanuts had previously completed skin-prick testing in the PROTECT trial and to date they have now completed three incremental subcutaneous dose levels over two months with no safety signals observed.

Healthy subjects in the PROTECT trial have received a 400-fold dose increase of VLP Peanut, providing strong confidence that the VLP technology within the vaccine candidate is safe and well tolerated at high cumulative doses. This is essential for further clinical development of VLP Peanut as the trial's external safety review committee agreed that the doses administered so far have been safe and well tolerated and dose increments in next cohorts can proceed as planned to similarly high doses in peanut allergic patients, to establish the dose range to be considered for the upcoming Phase IIb study.

The PROTECT trial continues to run as planned and data observed thus far supports the hypo-allergic safety profile of VLP Peanut which is a key step in realising its potential as a transformative option for peanut allergy sufferers. Efficacy suggestive biomarker analysis is expected to be available in Q4 2024.

This announcement contains inside information for the purposes of the UK Market Abuse Regulations.

-  ENDS -

For further information, please contact:

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

[phone]

Cavendish Capital Markets Limited (Nominated Adviser and Broker)

Geoff Nash /Giles Balleny/Seamus Fricker / Rory Sale

Nigel Birks/Tamar Cranford Smith - Sales

[phone]

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

[phone]

[e-mail]

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.

 

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