Arecor Therape Regulatory News (AREC)

Arecor Therapeutics plc ("Arecor" or the "Company")

2025 Business Update

Cambridge, UK, 9 February 2026: Arecor Therapeutics plc (AIM: AREC), a biopharmaceutical company focused on drug development and enhanced delivery in diabetes and other cardiometabolic diseases, provides a business update (unaudited) for the 12 months ended 31 December 2025. The Company's audited results will be issued during April 2026.

Highlights

AT278

Significant development and commercial progress has been made with Arecor's ultra-concentrated (500U/mL), ultra-rapid-acting insulin, most notably with the US Food and Drug Administration (FDA) and through partnering with insulin pump innovators as the preferred route to market.

In early September 2025 the Company had a positive Type C meeting with the FDA on a first-of-a-kind Phase 2 clinical study design for AT278, in combination with an Automated Insulin Delivery (AID) system in people with both type 1 and type 2 diabetes with high daily insulin needs. Positive feedback and guidance on this innovative clinical trial design was a major achievement for Arecor and a significant step towards a successful Phase 2 study.

That same month, Arecor and Sequel, a company developing state-of-the-art insulin delivery devices, announced a collaboration committing up to $1.3 million each to fund development work in preparation for the pivotal Phase 2 trial combining AT278 with Sequel's twiist™ AID system, which has been launched in the US.

The collaboration was discussed recently in a fireside panel discussion with Dr Sarah Howell (Arecor), Dr Alan Lotvin (Sequel), and Dr Thomas Blevins, a Key Opinion Leader in the field of Diabetes and Endocrinology - see the recording here.

Positive negotiations are in progress on a broader co-development and commercialisation partnership for the Phase 2 trial and beyond and are a current key focus for management.

Oral peptide delivery platform

This R&D programme is aiming to improve the bioavailability of peptides when delivered orally. The initial focus is to develop an oral GLP-1 (semaglutide) with improved bioavailability. Rybelsus®, a current approved oral semaglutide, has a bioavailability of <1%.

Non-clinical pharmacokinetic (PK) studies to inform the optimum approach to improve bioavailability are underway and will be on-going through 2026. During Q4 25, Arecor filed a patent application with the European Patent office, claiming novel compositions to improve the oral bioavailability of complex peptides.

Success with oral GLP-1 would be highly translatable to the oral delivery of a broad range of peptides, offering a significant commercial opportunity.

Financials

Total revenue for the year including discontinued operations is £3.1 million (2024: £5.1 million) with the decrease due to the cessation of operations at Tetris Pharma. This includes revenue for continuing operations* of £1.7 million (2024: £1.6 million). Cash and cash equivalents of £6.1 million (2024: £3.2 million) above expectations mostly due to favourable performance at Tetris.

* Continuing operations exclude Tetris Pharma, with the cessation of operations in September 2025.

Sarah Howell, Chief Executive Officer of Arecor, said:

"During 2025, we focused our strategy on two core product areas, AT278 for diabetes and the oral delivery of peptides, both of which are high growth multi-billion-dollar markets where our technology gives us an edge. The combination of AT278 with a device such as Sequel's twiist™ AID system addresses key unmet needs for people living with diabetes and is a compelling proposition for this growing market.

"We are also continuing to generate insights and data to inform next development steps for our oral peptide delivery platform, which has a low resource burden but a large commercial upside opportunity. These developments are supported by a solid financial position."

-ENDS-

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Notes to Editors

About Arecor

Arecor Therapeutics plc is a clinical stage biopharmaceutical company focused on drug development and delivery in diabetes and other cardiometabolic diseases. The Company is applying its proprietary technology platform, Arestat®, to develop a portfolio of proprietary products, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. Its lead product is AT278, the only ultra-concentrated (500U/mL) ultra-rapid acting insulin. Arecor is also developing a novel oral delivery platform for peptides (e.g. GLP-1 receptor agonists) targeting the obesity and diabetes markets. The Company is listed on AIM (AIM: AREC) and is based in Cambridge, UK. For further details please see www.arecor.com.

Arecor® and Arestat® are registered trademarks of Arecor Limited.

About AT278

AT278 is a novel proprietary formulation of an existing insulin, designed to accelerate the absorption of insulin post injection even at very high concentrations (500U/mL). With its best-in-class profile, it has the potential to disrupt the market for insulin treatment as the first concentrated, yet very rapid acting insulin for the growing population of people with diabetes with high daily insulin needs as well as to act as a critical enabler in the development of next-generation, miniaturised longer wear automated insulin delivery (AID) systems.