Allergy Therapeutics PLC (AIM:AGY, FRA:HHU) said it has enough cash to fund the current clinical trials of its grass allergy and peanut allergy vaccines with just a small amount of debt.
The next milestones for investors to look forward to include results from the Grass MATA MPL G309 exploratory field trial in the autumn, the pre-application meeting with the US Food and Drug Administration (FDA) for VLP Peanut, followed by the start in 2022 of the VLP Peanut Phase I PROTECT study in the US.
Chief executive Manuel Llobet said a read-out of the VLP Peanut trial is expected in the second half of 2023, but the design of the trial should allow the company to make interim reports of its progress.
“Overall, the next year provides multiple key inflection points with clinical and regulatory progress, and we look forward to providing the market with further updates,” he said.
There was £40.3mln of cash in the AIM-listed company’s coffers at the June end of its financial year.
The company said this will be sufficient, under current assumptions, to fund the two grass trials as well as the peanut Phase I trial, with a small amount of additional debt.
If the grass trials are successful, the only further trial that will be required before submission of the Biological Licence Application (BLA) is the completion of the safety database, it added.
The board is continuing to review the group's funding requirements and options for the future "including, but not limited to, a potential path to a Nasdaq dual listing".
The year to end-June saw Allergy Therapeutics report a net profit of £2.9mln on revenues of £84.3mln.
Research & development expenditure was stepped up to £12.9mln, from £9mln the year before, as the group invested in its pipeline with execution of the Grass MATA trial and scaling-up manufacturing for batches of the VLP Peanut vaccine candidate ahead of the upcoming study.
Llobet said the group is improving the quality of its portfolio by streamlining a number of non-differentiated older products to maintain its focus on short course subcutaneous immunotherapy (SCIT) and innovative allergy treatments.
This, alongside the ongoing impact of COVID-19, means that revenues in the new year are expected to grow at low single-digit levels at constant rates, while profit margins before R&D costs will temporarily be squeezed as operating costs are expected to be around 20% higher than 2021 due to delayed 2021 commercial projects, further investment in infrastructure and increased R&D activities, and some delayed costs from 2021.
Research and development expenditure next year is expected to be in the region of £4m more than 2021, reflecting completion of the grass study and beginning of the peanut trial.
“Allergy Therapeutics has performed well in 2021, driving our European commercial business and progressing our clinical programmes amid challenging conditions. Our commercial and pipeline products demonstrate our commitment to allergy and immunology solutions to help people worldwide,” Llobet said.
“Engaging with our stakeholders is key to our success as a business. They trust us to deliver safe and effective products on time, to stand by our values and to operate our business with high standards of quality and integrity.”