Arecor Therape Regulatory News (AREC)

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

Arecor Therapeutics plc

("Arecor" or the "Company")

Co-development Agreement with US Insulin Pump Device Company for AT278

and

Sale of Royalty and Technology Access Fees for up to $11 million

​

- AT278 (500U/mL) is the only ultra-concentrated and ultra-rapid acting insulin in development designed to enable the next generation of longer-wear and miniaturised automated insulin delivery (AID) systems

- Arecor and Sequel Med Tech, LLC to commit up to $1.3 million each to fund development work in preparation for pivotal Phase 2 trial for AT278-Insulin Pump programme

- Strategic intent is to progress to a broader co-development and commercialisation partnership for Phase 2 trial and beyond

- Non-dilutive funds raised through the monetisation of Arecor's royalty rights related to AT220 and milestone andtechnology access fees related to AT292

- Cash runway extended to 1H 2027

Cambridge, UK, 25 September 2025: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company focused on drug development and delivery in diabetes and other cardiometabolic diseases, has signed a co-development agreement with Sequel Med Tech LLC ("Sequel"), a company developing state-of-the-art insulin delivery technologies, to combine AT278 (500U/mL) with Sequel's twiist™ Automated Insulin Delivery (AID) system powered by Tidepool, and a royalty financing agreement with Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) ("Ligand") which will raise non-dilutive capital of up to $11 million (£8.2 million).

Sarah Howell, CEO of Arecor Therapeutics said:

"The co-development agreement for AT278 and the non-dilutive fund raising via the monetisation agreement are both major strategic achievements for Arecor. The Sequel agreement marks a key milestone, furthering our ambitions to realise AT278's significant benefits for people living with diabetes as well as building substantial value for our shareholders. The funding realised through the monetisation of specific royalty rights enables us to accelerate AT278's clinical development and extends our cash runway to 1H 2027 without diluting our shareholders."

Co-Development Agreement

To preserve long-term value within Arecor, the Company has pursued a strategic co-development partnership with an insulin pump innovator. Sequel's advanced AID technology aligns with Arecor's commitment to transformative drug delivery solutions. Its twiist™ AID System's iiSure™ technology leverages acoustic sensing to precisely measure each insulin dose, delivering superior dosing accuracy and detecting occlusions up to nine times faster than other automated insulin delivery systems. This high level of precision makes it an ideal complement to AT278's ultra-concentrated, ultra-rapid insulin product.

Under the terms of the agreement, Arecor and Sequel will co-fund all trial-enabling development activities for the AT278-AID System development programme to achieve Phase 2 trial-ready status. Each company will commit up to $1.3 million to accelerate and fund all Phase 2 clinical trial-enabling development work. This will include regulatory interactions and filings with the US Food and Drug Administration (FDA), clinical trial batch manufacturing and AID System compatibility work. Work will commence immediately and is expected to be completed during 1H 2026, culminating in the filing of an IND (Investigational New Drug). If approved, the programme would be ready to enter a pivotal Phase 2 clinical study during 2H 2026.

Longer term, both companies have confirmed their strategic intent to enter a broader, co-development and commercialisation partnership. This would enable the further development and future commercialisation of AT278 in a next generation AID system, serving a key unmet patient need in a high value market.

Sarah Howell, CEO of Arecor Therapeutics added:

"Sequel has expertise in the development and commercialisation of AID Systems, exemplified by the recent launch of the innovative twiist™ AID System. The pairing of AT278 - the only ultra-concentrated (500U/mL), ultra-rapid insulin in development - with the twiist™ AID system, enables longer wear, even for those people with diabetes (PwD) who require high daily doses of insulin, as well as future miniaturisation opportunities. This combination will unlock powerful benefits for more PwD and provide more choice in how they manage their diabetes. 

"We are proud to be bringing devices and therapeutics together in a collaboration which addresses a real unmet need in a high value market, helping people with diabetes better manage their blood glucose whilst significantly lowering the daily burden of disease management."

Alan Lotvin, CEO of Sequel Med Tech commented:

"We take a comprehensive approach to diabetes management, exploring every opportunity to improve systems that make life easier for people living with diabetes. Our collaboration with Arecor presents a unique opportunity to deliver a truly next-generation solution by integrating our twiist™ AID system - powered by precision iiSure™ technology - with Arecor's AT278, the only highly concentrated ultra-rapid acting insulin.

iiSure™ technology enables twiist™ to be the first system that directly measures the volume of insulin delivered with each microdose and includes 4 checkpoints along the way to help ensure accurate delivery -something no other AID system can do. This precision is especially critical when working with highly concentrated insulin. Together, this combination has the potential to expand the benefits of AID to all individuals on intensive insulin therapy and provide additional options for PwD, helping them achieve tighter glucose control and improved outcomes."

Market Opportunity

This partnership, including commercialisation outside the US, presents significant growth potential for Arecor. The Company estimates the total addressable US insulin revenue market opportunity for AT278 is very attractive at c.$2.9 billion with additional upside through commercialisation in Europe and other territories. This is driven by two high unmet-need market segments: 1) People with diabetes who require high daily insulin doses and prefer pumps yet currently lack a suitable pump option and 2) People with diabetes seeking the convenience of an extended-wear device with insulin capacity for 7+ days.

In the Arecor management's opinion, AT278 has the potential to be the only insulin that can enable and catalyse the next generation of longer wear and miniaturised AID systems, simplifying care, reducing care burden and broadening access to people living with Type 1 or Type 2 diabetes.

Arecor's strategic priority has been to pursue high-value R&D opportunities that have the potential to generate significant value for shareholders. Near term, the management anticipates that AT278, the ultra-concentrated, ultra-rapid acting insulin candidate, and the development of a novel oral delivery of peptides platform technology, offer the best opportunities to fulfil this aim. This partnership with Sequel Med Tech is a significant step forward in realising the benefits of AT278 for patients as well building significant value for shareholders.

Monetisation of Royalty and Technology Access Fee Streams

Arecor has sold the global royalty rights related to AT220, an Arestat®-enhanced biosimilar product marketed by a global pharmaceutical company, and all potential milestone and technology access fees related to AT292 (licensed to Inhibrx, now Sanofi's Efdoralprin alfa) (the "Royalty Financing Agreement") to Ligand.

Under the terms of the agreement, Ligand will pay Arecor up to $11.0 million (£8.2 million). This includes a $7.0 million upfront cash payment and an additional $4.0 million, which will be payable upon the achievement of certain commercial milestones related to AT220 and AT292, of which $1.0 million is expected to be received during 2026.

As part of the transaction, Ligand will receive warrants over 1,002,739 ordinary shares of 1 pence each in the Company ("Ordinary Shares") which will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares of the Company. The exercise price for the warrants will be 67.39 pence, being the 30-day volume-weighted average price at the date of the agreement. The warrants are exercisable over 10 years.

Arecor's strategic priority has been to pursue high-value R&D opportunities that have the potential to generate significant value for shareholders. Near term, the management anticipates that AT278, the ultra-concentrated, ultra-rapid acting insulin candidate, and the development of a novel oral delivery of peptides platform technology, offer the best opportunities to fulfil this aim. The royalty financing agreement provides immediate, non-dilutive capital, allowing the initiation of AT278 Phase 2-enabling activities without delay, and strengthens Arecor's balance sheet by extending the cash runway to 1H 2027. 

Sarah Howell, CEO of Arecor said:

"The royalty financing agreement with Ligand is also an important step forward. This financing extends our cash runway to 1H 2027, strengthening the balance sheet for future potential partnering discussions."

Todd Davis, CEO of Ligand said:

"We are excited to partner with Arecor on this compelling opportunity to invest in two partnered assets with significant commercial potential. This unique investment exemplifies the types of deals our team aims to pursue, focusing on highly differentiated, de-risked assets that are marketed by strong partners."

-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 enhanced therapeutic products. Its lead product is AT278, the only ultra-concentrated (500U/mL) ultra-rapid acting insulin which is now being co-developed with Sequel Med Tech, a company developing state-of-the art insulin delivery technologies. 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

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.

About Sequel Med Tech

Headquartered in Manchester, New Hampshire, US, Sequel is developing the next generation of transformative drug-delivery advancements. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel was co-founded by visionary Dean Kamen, serial entrepreneur Pablo Legorreta, seasoned medical device executive Bill Doyle and healthcare leader Alan Lotvin, MD. Sequel's focus is to bring the latest developments in science and technology to the marketplace, helping drive more accessible drug delivery. For more information, please visit www.sequelmedtech.com.

About AT220

Under a license agreement entered into in 2015, Arecor developed a novel and differentiated, Arestat®-enhanced formulation of its global pharmaceutical company partner's undisclosed product, AT220. The product was first commercialised by Arecor's partner in November 2023, generating royalties for Arecor under a worldwide license agreement.

About AT292

AT292 is an Arestat®-enhanced, optimised recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency, developed by Arecor under a license agreement entered into by Arecor and Inhibrx in 2020. In 2024 Sanofi acquired Inhibrx's assets and liabilities associated with AT292, now "SAR447537". A registration-enabling clinical trial of SAR447537 is underway.