Allergy Therapeutics share price, company news, analysis and interviews

Allergy Therapeutics (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced that the first subject has been dosed in the pivotal Phase III G306 trial, to evaluate the efficacy and safety 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.

• Innovative short-course grass pollen immunotherapy with best-in-class potential

• If successful, Grass MATA MPL will be the first subcutaneous and aluminium‑free short-course allergy immunotherapy approved in the US

• Topline safety & efficacy data for Grass MATA MPL expected Q4 2023

• Safety, tolerability and efficacy data for VLP peanut expected 2023

Grass MATA MPL incorporates MicroCrystalline Tyrosine (“MCT^®“) adsorbed allergoids, and the innovative adjuvant Monophosphoryl-lipid A (“MPL”). This innovative technology only requires patients to receive six injections prior to the grass allergy season to be protected.

The pivotal Phase III G306 trial is a multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to confirm the efficacy and safety of Grass MATA MPL. The clinical trial will be conducted in the US and Europe at approximately 120 clinical trial sites. Data readout is planned for Q4 2023.

Previously announced top-line results from the G309 exploratory field trial showed meaningful and statistically significant reductions in symptoms due to grass pollen allergy and in the use of relief medications after six SCIT injections with Grass MATA MPL during peak grass pollen season.

In addition, the first subjects have been screened and are poised to receive the Group’s innovative, short-course peanut allergy vaccine candidate, VLP Peanut in the Phase I PROTECT trial. The first-in-human study is evaluating the safety and tolerability of VLP Peanut in healthy and peanut allergic adult subjects and exploring preliminary proof of efficacy. Plans remain on track for data in 2023.

Update on production and funding

Further to the announcement on the 28^th October, work is continuing on cost control and tight capital management following the impact of the pause in production. This includes reviewing all funding options and managing the working capital of the Group.

Manuel Llobet, CEO of Allergy Therapeutics, commented: “The start of our pivotal Phase III G306 trial investigating the efficacy and safety of our Grass MATA MPL marks the culmination of our efforts to bring this innovative treatment to millions of patients affected by grass allergies in both the US and Europe. We were encouraged by the results of our short-course grass pollen immunotherapy in the highly successful G309 exploratory field trial and look forward to advancing the development of this innovative treatment. The start of the VLP Peanut PROTECT trial is a significant milestone and a testament to the hard work of the Allergy Therapeutics team, developing innovative approaches that have the potential to transform the way we treat and manage allergies.”

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 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 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.

Allergy Therapeutics plc is an international commercial biotechnology company 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 and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.

Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m² of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which employs c.600 employees, is listed on the London Stock Exchange (LON: AGY).

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has today announced the appointments of Anthony Parker and Zheqing (Simon) Shen as Non-Executive Directors of the Company, with immediate effect. Anthony represents Southern Fox Investments Limited and Simon represents ZQ Capital Management Limited acting through its affiliate SkyGem Acquisition Limited, both significant shareholders of the Company.

Anthony has worked in investment banking and fund management for over thirty years and, as Founder and Partner of Beagle Partners LLP, which advises Southern Fox, has managed or advised on multiple UK innovation technology investments. He is Founder and Chairman of Argonaute RNA Ltd, a UK-based research company developing safe and reliable methods of temporarily silencing target genes in different tissue cells. Prior to this, Anthony held senior roles at ING Barings and was an equity analyst for Cazenove & Co. He holds an Investment Management Certificate from the Institute of Investment Management and Research.

Simon founded the investment and advisory firm, ZQ Capital, in 2015. Prior to that he spent more than a decade as an investment banker advising international companies on their capital markets activities. He was Managing Director and Head of China Financial Institutions Group at Barclays from 2011 to 2015, following earlier roles at Goldman Sachs, Lehman Brothers and McKinsey & Company. He has a BA in mathematics and economics from Wesleyan University.

Peter Jensen, Non-Executive Chairman of Allergy Therapeutics, commented: “On behalf of the Board I would like to welcome Anthony and Simon. Southern Fox and ZQ Capital have been long-standing and supportive shareholders of Allergy over many years, and I have no doubt Anthony and Simon will be invaluable members of the Board, bringing extensive business and innovation sector experience.”

Additional Disclosures

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules of Companies.

Mr Anthony Michael Parker (aged 60) holds, or has held, the following current and former directorships and partnerships in the past five years:

Mr Parker holds 275,000 ordinary shares in the capital of the Company. Mr Parker does not hold any options, rights to subscribe or other interests in such shares.

Mr Zheqing (Simon) Shen (aged 43) is, or has been, a director or partner of the following companies or partnerships during the past five years:

Mr Shen holds 90,000 ordinary shares in the capital of the Company. In addition, ZQ Capital, through its affiliate Skygem Acquisitions Limited holds 173,650,037 ordinary shares in the capital of the Company and also holds warrants over 16,666,666 ordinary shares. Mr Shen is managing partner and founder of ZQ Capital Mr Shen does not hold any other shares in the capital of the Company, nor any options, rights to subscribe or other interests in such shares.

Save as set out above, no further information regarding Anthony Parker or Zheqing (Simon) Shen is required to be disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies.

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced the appointment of Martin Hopcroft to the role of Interim Chief Financial Officer (CFO). Martin will report into Chief Executive Officer, Manuel Llobet.

Martin brings significant financial experience across multiple industries. He served as CFO of Novasep SA, a supplier of pharmaceuticals and biopharmaceuticals, and during his tenure Novasep won a major contract with AstraZeneca to support the large-scale production of the active substance of its adenovirus vector-based COVID-19 vaccine. Martin previously served as CFO of formerly listed Cambian Group plc, a provider of specialist residential and educational services for children and young adults, and of Consort Medical plc, a medical devices company.

The appointment of Martin Hopcroft follows the announcement on 26 May 2022 that Nick Wykeman, CFO, will leave Allergy Therapeutics on 30 November 2022 to pursue non-executive roles. The Group is continuing its search for a permanent CFO and will make a further announcement in due course.

Manuel Llobet, Allergy Therapeutics Chief Executive Officer, commented: “Martin is a highly experienced executive and it is my pleasure to welcome him to Allergy Therapeutics’ senior management team. I also want to take this opportunity to again thank Nick Wykeman for his work and dedication over the past six years and I wish him the very best for his future.”

Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergen immunotherapy, has announced that it will resume production at the Freeman facility, part of its Worthing, UK manufacturing site, on 14^th November.

The Group announced a short-term voluntary pause in production following an internal review of its current operating processes. This pause was part of the Group’s previously communicated ongoing programme to improve the robustness of its quality systems and build capacity across its manufacturing facilities but was accelerated when it became clear that the capacity was unable to cope with the commercial demand.

The pause in manufacturing occurred during a period of peak production prior to the start of the pollen season in the spring. As a consequence, whilst it is too early to determine the exact impact, it is currently estimated that revenue will be between approximately 13% and 18% lower than market expectations of circa £80m at current exchange rates for the year ended 30 June 2023. Business expenses for the same period are currently expected to reduce by around £3m.

Work is continuing to further minimise the impact through cost control and tight working capital management and delay in non-critical capital spend.

At the expected reduced levels of underlying profit, excluding research and development costs, the terms of the NatWest revolving credit facility would not allow use of the facility.

Manuel Llobet, CEO at Allergy Therapeutics, stated: “We took the difficult decision to temporarily pause production at the Freeman facility to continue delivering the highest standards of quality systems. We are now pleased to have a clear timeline to resume our UK manufacturing activities.”