Arecor’s 2025 results: progress on AT278 and a push into oral peptides
Arecor Therapeutics has delivered a year of strategic refocusing and tangible progress in its two core areas: diabetes and oral peptide delivery. The headline is clear – AT278, its ultra-concentrated, ultra-rapid insulin, is edging towards Phase 2 with regulatory clarity and a device partner on board, while the newer oral GLP-1 programme moved from concept to early data and IP filing. Financially, non-dilutive cash from a royalty sale strengthened the balance sheet and extended the cash runway into 2027, albeit with the usual going-concern caveats you’d expect from a clinical-stage biotech.
Below I break down what changed, why it matters, and what to watch next.
AT278 ultra-concentrated insulin moves toward Phase 2 with Sequel
AT278 is the only 500U/mL, ultra-rapid insulin in development. That concentration matters. Today’s pumps typically use 100U/mL insulin – which doesn’t work well for people needing higher daily doses or for longer wear times. AT278’s combination of higher strength and faster action is designed to unlock 7-day wear and future miniaturised pumps.
- FDA feedback: A positive Type C meeting confirmed the proposed first-of-its-kind Phase 2 design – AT278 delivered via an Automated Insulin Delivery (AID) system in people with type 1 and type 2 diabetes.
- Device partner: Co-development deal with Sequel Med Tech to combine AT278 with Sequel’s twiist AID system. Each party is committing up to $1.3 million to Phase 2-enabling work, which is “progressing to plan”.
- Timing: Phase 2 is anticipated to start in 2H 2026, subject to FDA approval and additional funding. Post year end, Arecor and Sequel confirmed their intent to expand into a broader co-development and commercialisation partnership.
Jargon buster:
- AID system: an automated insulin delivery pump that adjusts insulin using continuous glucose data.
- PK/PD: how a drug moves through the body (pharmacokinetics) and its effect on the body (pharmacodynamics).
- IND: Investigational New Drug application – the FDA’s green light to start a US clinical trial.
Why AT278 could be a category unlock
The 2026 ADA guidelines set AID systems as the preferred method of insulin delivery for type 1 and for type 2 on multiple daily injections. But anyone needing more than 100 units per day can’t get a full 3-day wear with current 100U/mL insulins, and 7-day wear becomes even more challenging. AT278 directly targets this bottleneck.
- Initial target segments in the US: around 2 million people across those on over 100U/day and those already using pumps.
- Initial US addressable market: over $3 billion per annum, with Arecor expecting to capture a meaningful share (exact share not disclosed).
- Clinical status: two prior Phase 1 studies showed superiority vs current gold-standard rapid insulins in both type 1 and high-BMI type 2 populations.
My take: securing the device route early is smart – pump compatibility and usability will be decisive for adoption. The Phase 2 trial design is ambitious, but if it generates strong Time-in-Range and wear-time data, it will build both clinical and economic arguments for payers and pump partners.
Oral GLP-1 platform: early wins, 2026 data coming
Arecor is applying its formulation know-how to crack oral delivery for peptides, starting with semaglutide (the GLP-1 class). Today’s oral semaglutide has bioavailability below 1%. Arecor’s aim is to materially improve this.
- 2025 progress: initial positive in-vitro stability for semaglutide formulations and a new patent filing claiming compositions that improve oral bioavailability of complex peptides.
- 2026 plan: run non-clinical pharmacokinetic studies to choose the best path to boost bioavailability.
My take: this is earlier stage but strategically interesting. Success here would be highly translatable to other peptides and could open multiple partnering options. For now, investors should watch for the 2026 PK readouts.
Royalty sale to Ligand boosts cash and trims dilution
In September, Arecor sold certain royalty and milestone rights tied to AT220 and AT292 to Ligand Pharmaceuticals for up to $11 million. This was non-dilutive and immediately helpful to the runway.
- Cash received upfront: £5.186 million (equivalent to $7 million).
- Milestones: up to a further $4 million; £0.5 million has already been received in 2026 and another £0.5 million is expected during 2026.
- Accounting: gain-on-sale of intangible assets of £4.968 million recognised in 2025.
Opinion: a sensible bridge that funds AT278 work without issuing equity in a tough market. It also strengthens the hand for negotiating a broader AT278 device-commercial deal.
Core Arestat partnering and IP: steady execution
- Three new Arestat formulation collaborations signed with total pre-licence revenue of over £1 million.
- Seven new patents granted across key territories, including protection for AT247 and AT278 in Europe, the US and Canada, plus a new filing for oral peptide compositions.
These are useful option-creating moves – small now, but they keep the partnering funnel active and enhance long-term defensibility.
Financial review: profit on paper, cash runway to 2027
Discontinued operations at Tetris Pharma are now out of the core picture, which helps focus resources on the higher-value pipeline.
| Metric (continuing operations unless stated) | 2025 | 2024 |
|---|---|---|
| Revenue | £1.714 million | £1.643 million |
| Total revenue incl. discontinued | £3.1 million | £5.1 million |
| Other operating income | £5.534 million | £0.267 million |
| Profit/(loss) before tax | £0.994 million | £(5.093) million |
| Adjusted EBITDA | £(3.506) million | £(4.665) million |
| R&D spend | £2.694 million | £3.041 million |
| Cash and short-term investments | £6.130 million | £3.257 million |
| Upfront cash from Ligand | £5.186 million | £- |
| Discontinued operations loss after tax | £0.268 million | £5.073 million |
The swing to a small statutory profit was driven by the royalty-sale gain. Under the bonnet, adjusted EBITDA stayed negative at £3.5 million, as you’d expect at this stage. Management guides to a base-case cash runway into May 2027 (April 2027 in a downside), and states the business expects to raise additional funding by May 2027. The auditor again references a material uncertainty around going concern – standard for small clinical biotechs, but still a risk marker.
Positives and pressure points
- Positives: FDA-aligned Phase 2 design; device partner in place; non-dilutive funding secured; cash nearly doubled year-on-year; IP broadened; partnering momentum maintained.
- Pressure points: Phase 2 still requires additional funding; adjusted EBITDA remains negative; overall revenue small; execution risk on the broader Sequel deal; clinical and regulatory risk as AT278 moves beyond PK/PD into AID outcomes.
What this means for investors
Arecor has sharpened its story. AT278 is the value driver, with a credible route to market through AID partners and a clear patient need that current 100U/mL insulins struggle to meet. The oral peptide platform is an attractive call option with 2026 data catalysts. The Ligand deal provided timely, non-dilutive cash and leverage for negotiations.
The next 12 months are about de-risking execution – locking in a broader Sequel deal, filing the IND and starting the Phase 2, while generating PK results on oral GLP-1. Funding remains a watch item into 2027, but the company has bought itself time to deliver those milestones.
Key milestones to watch in 2026
- Formalisation of a broader co-development and commercialisation agreement with Sequel for AT278.
- Completion of Phase 2-enabling work and IND submission for the AT278/AID study.
- Start of the Phase 2 clinical trial in 2H 2026 (subject to FDA clearance and funding).
- Receipt of the remaining expected $0.5 million milestone from Ligand during 2026.
- Non-clinical pharmacokinetic data for the oral GLP-1 platform and clarity on the bioavailability path.
- Additional Arestat collaborations or licences and any updates to IP coverage.
Bottom line
This is a cleaner, more focused Arecor. If AT278 proves its worth inside an AID system and the Sequel partnership expands as guided, the commercial opportunity is compelling. It is still a clinical-stage risk profile with a funding need on the horizon, but the company has lined up the right pieces for a pivotal 2026-2027. For investors comfortable with biotech development risk, the catalysts are now in view.
