Arecor Therape Regulatory News (AREC)

Arecor Therapeutics plc

("Arecor" or the "Group")

YEAR END TRADING UPDATE

- Patient enrolment complete in AT278 clinical trial and on track for key data readout in 1H 2024

- First commercial launch of product incorporating Arestat?, AT220, triggering milestone payment and now generating royalties

- New revenue-generating technology partnership agreements signed

- Total Income of £5.6 million (2022: £3.5 million) including grant income

- Total Group revenue of £4.6 million (2022: £2.4 million) representing c.90% growth

- Tetris Pharma product sales increased to £2.9 million (2022: £1.0 million) with a focus on the commercial roll-out of Ogluo®

- Cash and cash equivalents balance of £6.8 million, ahead of market expectations

Cambridge, UK, 1 February 2024: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today's therapies to enable healthier lives, provides a business update and announces that its audited final results for the 12 months ended 31 December 2023 will be issued during the week commencing 22 April 2024.

Sarah Howell, Chief Executive Officer at Arecor, said: "With a first commercial product incorporating Arestat? launched in late 2023 and now generating royalties, license milestones triggered on partnered products, a stream of new pharma technology partnerships and continued momentum with our diabetes portfolio clinical development, we continue to realise the potential of our Arestat? platform and, in doing so, are building a significant biopharmaceutical company. We are encouraged by the continued success of the Tetris Pharma roll-out of Ogluo® across the UK and Europe, which is reflected in strong sales performance as awareness and access to this key diabetes product increases. Looking forward, with further partnerships anticipated from our in-house proprietary specialty hospital portfolio, in addition to key Phase I clinical data for AT278 expected in 1H 2024, we look forward to continued growth and value creation for 2024."

Trading for the full year ended 31 December 2023

The strong commercial performance across the Group is reflected in the increased revenue for the full year of £4.6 million or c. 90% growth compared to £2.4 million recognised in the prior year. Total Income of £5.6 million (2022: £3.5 million) included grant income from the Innovate UK 2021 award. The Group closed its financial year with cash and cash equivalents of £6.8 million (2022: £12.8 million).

Revenue, total income, closing cash and cash equivalents balances are unaudited, with the Group's audited results to be issued during the week commencing 22 April 2024.

Licensed programmes - validating the value of the Arestat? platform to patients and growing a diversified revenue stream

Commercialisation by Arecor's partner of the first product incorporating Arestat? technology, AT220, was a significant milestone for the Group, further demonstrating the strength of its technology and its value to partners and ultimately patients. The first commercial sale in November triggered a license milestone payment and Arecor is now receiving royalties on product sales with initial royalties for the short period post launch included in 2023 revenues.

In addition to AT220, Arecor has two further partnered programmes under license - Hikma's development of ready-to-use injectable medicine AT307, and Inhibrx's development of alpha-1 antitrypsin deficiency therapy AT292 (INBRX-101), which continue to advance well under our partners' control and have both generated license milestone payments to Arecor within FY 2023.

Last month, Inhibrx and Sanofi announced that the companies have entered into a definitive agreement under which Sanofi will acquire all the assets and liabilities associated with INBRX-101. That announcement is a further endorsement of the Group's Arestat? platform and highlights both the value of this novel therapy for patients and its future commercial potential. The Group believes that Sanofi is well placed to complete the late-stage development of this novel medicine and, ultimately, bring it to patients in need.

In December, the Group announced a co-development and exclusive licence option agreement with a leading global medical products company for a high-value, ready-to-dilute oncology product from Arecor's proprietary Specialty Hospital pipeline. The agreement involves further co-development and regulatory work which is now underway. The agreement includes an option for the partner to exercise a license to further develop and commercialise the product, with Arecor eligible to receive potential developmental milestones.

Technology partnerships - new revenue-generating collaborations

Our portfolio of technology partnerships with leading pharmaceutical and biotechnology companies, to enhance their proprietary products across a range of indications and stages of development, continues with five new agreements signed in 2023 and earlier this year. These continue to validate the strength and the need for the Arestat? technology platform, provide near term revenue generation and also significant upside recurring revenue potential from future licensing.

In November, the Group signed a further collaboration with an existing partner, Lilly, to develop a novel liquid formulation of one of Lilly's key products with enhanced properties. That was followed last month with the expansion of an ongoing, exclusive formulation study collaboration with the pharmaceutical division of one of the world's largest chemicals marketing and pharmaceuticals companies, to develop a differentiated, ready-to-use liquid formulation of the company's product, AT351. In both collaborations, the Group's partners are funding the development work with options to acquire the rights to the new proprietary formulations and associated intellectual property under Arecor's technology licensing model. Both illustrate partner companies' confidence in the Group's expertise and its value as a partner of choice in the development of enhanced safe, efficacious and more convenient treatments that improve patient outcomes.

Further technology partnerships, the out-licensing of programmes from those partnerships, together with new licenses from the Group's proprietary pipeline, are anticipated to continue driving revenue growth in 2024.

Diabetes - creating a disrupter insulin

Diabetes has reached pandemic levels, with approximately 537 million adults living with diabetes worldwide. There are still significant unmet needs in diabetes care and the Group is focussed on developing much faster acting and more concentrated, rapid acting insulins, to improve treatment options and outcomes for this growing patient population within the existing $6.4 billion meal-time insulin market. The Group's Phase I clinical study of ultra-concentrated, ultra-rapid acting insulin candidate AT278 in the type 2 diabetes population, has completed patient enrolment and is on track to deliver results in 1H 2024. AT278 has the potential to be a critical enabler in the development of next generation miniaturised and longer wear insulin delivery systems, which are a significant area of focus for the major insulin device companies today.

Tetris Pharma - continued success of Ogluo® roll-out

The Group's specialty pharmaceutical business, Tetris Pharma, continues to build sales momentum through the commercial roll-out of its ready-to-use glucagon auto-injector pen for severe hypoglycaemia, Ogluo®. The increase in Tetris Pharma product sales to £2.9 million (2022: £1.0 million) was driven by Ogluo®, which now represents the majority of product sales. The appointment last month of Dr. Helen Parris as Senior Vice President, Commercial and General Manager of Tetris Pharma, is an important catalyst to continue to drive Tetris Pharma revenue.

This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 ("UK MAR").

-ENDS-

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Notes to Editors

About Arecor

Arecor Therapeutics plc is a globally focused biopharmaceutical group transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary formulation technology platform, Arestat?, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver enhanced formulations of their therapeutic products. The Arestat? platform is supported by an extensive patent portfolio. For further details please see our website, www.arecor.com