Arecor Therape Regulatory News (AREC)

Arecor Therapeutics plc

("Arecor" or the "Group")

BUSINESS UPDATE

- Strong pipeline of revenue-generating collaborations with major pharmaceutical and biotech companies with further deals anticipated during H2 and beyond

- Significant progress across proprietary diabetes focused portfolio with AT278 scheduled to complete within Q4 2023

- Good partner progress across licensed portfolio

Cambridge, UK, 20 July 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today's therapies to enable healthier lives, today provides a business update and announces that its interim results for the six months ended 30 June 2023 will be issued in mid-September.

Arecor is pleased to report strong progress across the business in the first half of 2023, with advances across its in-house and partnered programmes and continued success in the roll-out of Ogluo® in key territories. Arecor looks forward to providing a full update on performance and outlook at the time of its interim results. The Group's unaudited cash position at 30 June 2023 was £8.2 million.

Sarah Howell, Chief Executive Officer at Arecor, said: "We have continued to make significant progress across all areas of the business, strengthening the foundations for future growth across our in-house proprietary products and partnered programmes and supported by a revenue contribution from our commercial subsidiary, Tetris Pharma. Later this year we expect key data for AT278 and anticipate further value inflection points within our licensed product portfolio. With further partnerships and collaborations expected, we are continuing towards our ambition of building a significant self-sustaining biopharmaceutical company."

The Group has continued to make strong progress across its proprietary diabetes focused portfolio. The second Phase I clinical trial of AT278 in Type 2 diabetic patients is scheduled to complete within Q4 2023. AT278 is an ultra-rapid, ultra-concentrated (500U/mL) insulin candidate that has been designed to accelerate the absorption of insulin post injection, despite a 5-fold increase in concentration compared with 100U/mL insulins available to patients today. It has the potential to become the gold standard treatment for the growing population of people with diabetes with high daily insulin needs as the first and potentially only concentrated, yet rapid acting insulin. A truly rapid acting, concentrated insulin is also a critical step towards the advancement of the next generation of longer wear and miniaturised insulin delivery devices. Positive results from the Group's second Phase I clinical trial investigating ultra-rapid acting insulin product candidate, AT247, presented at the American Diabetes Association (ADA) 83rd Scientific Sessions meeting in June 2023, clearly demonstrate faster insulin absorption than current, gold-standard, rapid acting insulins and reinforce AT247's potential to enable a fully closed loop artificial pancreas - a life changing treatment approach for people living with diabetes.

The Group maintains a strong pipeline of revenue-generating collaborations with major pharmaceutical and biotech companies with further deals anticipated in H2 and beyond. In June 2023, the Group entered into a revenue-generating agreement with a leading biopharmaceutical company to support development of a biosimilar product. This collaboration follows an earlier technology partnership between the two companies, further demonstrating the strength and relevance of the Group's technology platform and expertise. This was the second agreement signed in the first half of 2023, after an additional formulation agreement with an existing Top 5 pharma partner in February, bringing the total number of new technology partnerships signed to 10 since IPO. These partnerships deliver revenue and offer significant upside potential from licensing under milestone and royalty bearing agreements.

The Group's three licensed programmes, under milestone and royalty-based agreements or equivalent, have also advanced. Arecor continues to expect the first product incorporating its Arestat™ technology, AT220, to be commercialised by its partner under a royalty-generating license agreement in a multi-billion dollar market, with US FDA approval anticipated in H2 2023.

In addition, Hikma continues to progress AT307, a ready-to-use ("RTU") injectable medicine after its milestone-triggering transfer from Arecor in January 2023. The Group was also pleased to note, in April 2023, that its partner Inhibrx initiated a registration-enabling trial of INBRX-101, an Arestat™ formulated optimized recombinant human AAT-Fc fusion protein, for treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD).

Tetris Pharma, the speciality pharmaceutical company acquired by Arecor in August 2022, continues the European commercial roll out of its key diabetes product, Ogluo® (glucagon prefilled autoinjector pen), adding Denmark and Norway in May 2023, to existing markets in Austria, Germany and the UK, and sales continue to grow. During the remainder of H2 2023, Tetris Pharma will focus on accelerating market adoption of Ogluo® and roll-out across key territories. With this continued focus on growing and maximising the value of Ogluo® in the UK and Europe, Dr Shafiq Choudhary, Founder and Managing Director, will be leaving the business later this year following a handover period. The Management Team and Board of Arecor thank Shafiq for his contribution and commitment since the acquisition.

The momentum we are seeing and the increasingly pan-European focus of our commercial efforts provide the Group with continued confidence in Ogluo®. Sales of Gvoke® in the US also remain strong with continued quarter on quarter growth and, while the market dynamics clearly differ, the US experience provides further support for the Group's belief in the growth potential of the product in the UK and Europe.

The Group has continued to strengthen its patent portfolio to protect its Arestat™ technology platform and proprietary pipeline products, with six new patent grants this year, most recently, in June 2023, announcing key patents from the European Patent Office and the China National Intellectual Property Administration, protecting novel formulations of AT278 and AT247. The Group's intellectual property (IP) portfolio currently comprises 36 patent families, including >75 granted patents in Europe, the US and in other key territories.

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