GENinCode Reports 14% Revenue Growth and Advances US FDA Submission for CARDIO inCode

GENinCode final results: revenue growth is real, but this is still a high-risk scale-up story

GENinCode’s 2025 results show a business moving forward commercially, especially in the US, but not yet financially comfortable. Revenue rose 14% to £3.076 million, gross margin improved nicely, and the company landed some genuinely meaningful strategic wins around FDA progress, reimbursement and Thermo Fisher.

That said, this is not a “job done” update. Losses widened, year-end cash was only £827,000, and the company had to raise £4.7 million after the period end to keep pushing the commercial roll-out. For retail investors, the big picture is simple: the opportunity looks bigger, but so does the execution risk.

Key number	FY25	FY24
Revenue	£3.076 million	£2.701 million
Gross profit	£1.804 million	£1.426 million
Gross margin	59%	53%
Adjusted EBITDA loss	£4.866 million	£4.447 million
Loss for the year	£5.705 million	£4.434 million
Cash at year end	£827,000	£1.110 million
Operating cash outflow	£4.124 million	£5.173 million

Why the CARDIO inCode FDA submission is still the main event for GENinCode shares

The standout issue here is CARDIO inCode-Score, GENinCode’s coronary artery disease polygenic risk score, or PRS. A polygenic risk score is a genetic test that combines lots of tiny genetic signals to estimate a person’s inherited risk of disease. In plain English, it is trying to spot people who may be at higher risk of heart disease before the damage is done.

The FDA process remains the critical swing factor. GENinCode said the FDA ‘De Novo’ supervisory review has been completed, but discussions were extended to resolve outstanding deficiencies, with a new De Novo pre-market approval submission expected in Q3 2026.

That wording matters. It means this has not been waved through. The company said the remaining work relates mainly to multi-ethnic population data and the supporting statistical and medical review, with clinical studies under way through Kaiser Permanente.

My take: this is progress, but investors should not confuse progress with certainty. Management is targeting approval by the end of Q4 2026, but that is still a target, not an outcome.

Thermo Fisher collaboration and US guideline changes could unlock much bigger adoption

The best commercial news in the RNS is arguably not the current revenue number, but the infrastructure being built around future revenue. In December 2025, GENinCode signed a collaboration with Thermo Fisher Scientific to manufacture, distribute and sell CARDIO inCode-Score through Thermo Fisher’s lab network in the US and EMEA.

That is a serious partner. It gives GENinCode a route into a much bigger installed base of laboratories using Thermo Fisher’s QuantStudio 5 Dx Real Time PCR System, which should help if demand ramps.

There are two catches, though. First, the agreement is non-exclusive and runs for three years, extendable. Second, pricing and distribution terms are still under discussion, so the economics are not disclosed yet.

There is also a timely tailwind from the American College of Cardiology and American Heart Association. Post period end, those bodies updated lipid management guidelines to include coronary artery disease polygenic risk scores as a new “risk enhancer” for preventing heart disease.

That is a big deal because clinical guidelines often shape doctor behaviour and reimbursement decisions. It does not guarantee sales, but it does move the conversation from “interesting concept” to “recognised tool”.

US commercial traction is improving, but the revenue base is still small

GENinCode said it had over 45 clinics and hospital institutions onboarded by the end of 2025, rising to over 70 US institutions and clinics in the first four months of 2026. That is encouraging, and management says orders are ramping up.

Still, investors need to keep one eye on the actual revenue base. US revenue in FY25 was only £155,000, up from £143,000 in FY24. So while the story sounds exciting, the income statement shows the US opportunity is still early-stage.

Reimbursement progress helps. CARDIO inCode-Score was included in the 2025 US Clinical Lab Fee Schedule with a median price of $500 per test, and LIPID inCode has an average insurance reimbursement of $1,229. Those figures matter because diagnostic adoption often lives or dies by who pays.

GENinCode balance sheet risks: cash, dilution and the going concern warning

This is the part investors should not gloss over. GENinCode ended 2025 with £827,000 of cash and total equity of just £124,000. It then completed a £4.7 million placing in February 2026 by issuing 466,159,095 shares at 1.0 pence each.

That fundraise gives breathing room, but it came with heavy dilution. The total number of ordinary shares in issue increased from 286,882,042 at 31 December 2025 to 753,041,137 after the placing.

The company also included a formal going concern warning. In plain English, “going concern” means the business expects to keep operating for at least the next 12 months. GENinCode says it has prepared the accounts on that basis, but it also says there is a material uncertainty because revenue growth may not arrive as forecast and an extra fundraise might be needed if it does not.

That is the biggest negative in the results, in my view. Operational momentum is improving, but the business is still dependent on execution and external funding.

UK, Europe and ROCA give support, but NHS headwinds are clearly slowing progress

Europe remains the financial backbone for now. Spain generated £2.105 million of revenue in FY25, well ahead of the UK at £538,000, Italy at £187,000, Germany at £87,000 and the US at £155,000.

The NHS story is mixed. GENinCode says LIPID inCode has processed around 2,800 familial hypercholesterolaemia, or FH, tests over the past 24 months in North-East and North-Cumbria, with over 500 positive FH patients identified. That is a strong real-world proof point.

But the company is also blunt that major strategic, organisational and funding changes across the NHS have created headwinds. That explains why first four months 2026 revenue was only broadly in line with the same period last year despite all the upbeat commercial language.

ROCA also adds another angle. The company announced its first NHS commercial contract with UCLH, and says discussions are continuing with other NHS trusts. Useful progress, but revenue contribution from ROCA is not disclosed.

Is this GENinCode RNS positive for investors?

On balance, yes – but only if you view it as a progress update rather than a proof of profitability. The positives are clear: revenue growth, better gross margin, stronger US onboarding, reimbursement momentum, guideline support and a potentially valuable Thermo Fisher partnership.

The negatives are just as clear: losses are still large, US revenue is still tiny, the FDA process is unfinished, and shareholders have already taken substantial dilution. Add in the going concern warning, and this remains a speculative AIM share rather than a steady compounder.

If I were watching the next few updates, I would focus on four things. First, whether revenue growth actually accelerates in 2026. Second, whether Thermo Fisher pricing and distribution terms get nailed down. Third, whether the FDA submission lands in Q3 2026 as promised. And fourth, whether cash lasts without another raise.

That is the investment case in a nutshell. The market opportunity may be large, but GENinCode still has to convert promise into repeatable, funded, profitable growth.