The Ledger on Exvastat's EIC Accelerator IV Imatinib for ARDS

Acute respiratory distress syndrome (ARDS), in which fluid floods the lungs, had no authorised treatment in the EU in 2020 and was the immediate cause of death of COVID-19 patients, according to CORDIS. Exvastat, a Cambridge start-up majority-owned by the venture investor Cambridge Innovation Capital, thought it had a drug for it: imatinib, a cheap leukaemia pill, reformulated as an intravenous drug called Impentri for unconscious patients on ventilators. The European Innovation Council selected the project among the COVID-19-related winners of its March 2020 EIC Accelerator pilot cut-off, according to the Commission's list of selected companies, and paid for a Phase II trial in India. That trial was approved, opened, and treated no one: COVID-19 admissions in India collapsed in the autumn of 2021, the regulator refused to widen the trial to other pneumonia patients, and it was terminated, according to the project's final CORDIS report, which concludes that "there are no project results that can be exploited".

The company behind it no longer exists. Exvastat Ltd was dissolved by voluntary strike-off on 15 April 2025, according to Companies House, and its Irish subsidiary, Exvastat (Ireland) Limited, the name under which the EC list published the award, was dissolved on 10 March 2025, according to the Irish Companies Registration Office's open company data.

Where Exvastat Stands Now

Exvastat Ltd's filing history at Companies House ends with an application to strike the company off on 21 January 2025, a first Gazette notice on 28 January and the final notice of dissolution on 15 April 2025. Its last accounts, for 2024, filed on 8 January 2025, showed £324,719 in current assets, £231,451 in provisions for liabilities and net assets of £88,700, with two employees. The Irish subsidiary appears as terminated on North Data, with its last accounts filed for 2023, matching the CRO record.

The company's website carried the same front page from at least September 2023 to January 2025, with a February 2022 news item as its latest entry, according to Wayback Machine copies. The exvastat.com domain now redirects to another company's website. No sale of Impentri, its patents or its data to another company could be found. The European Medicines Agency's register still lists imatinib for ARDS as a positive orphan designation, with Exvastat (Ireland) Limited, a dissolved company, as its sponsor.

The Technology: A Leukaemia Drug for Leaking Lungs

Imatinib, sold by Novartis as Gleevec, inhibits several tyrosine kinases and is used to treat chronic myelogenous leukaemia and other cancers, according to CORDIS. Researchers in Amsterdam found that it also tightens the lining of blood vessels after a woman with life-threatening fluid in the lungs, treated off-label in 2008, recovered within 24 hours, according to Exvastat's website and a 2020 Scrip interview with Cavalla, reprinted by Cambridge Innovation Capital. ARDS treatment was otherwise "limited to supportive ventilatory care", the website said. Imatinib exists only as a pill, which patients in a coma cannot swallow, so Exvastat's claim was "the first stable formulation of imatinib" for intravenous use, made by the Canadian contract laboratory KABS, according to the CORDIS report of its second EU project. Cavalla told Scrip that the company held European and US patents for intravenous imatinib.

The evidence for imatinib in COVID-19 came from CounterCOVID, a Dutch trial of the oral drug in 385 hospitalised patients. It missed its primary endpoint, time to coming off oxygen (hazard ratio 0.95), but 15 of 197 patients on imatinib died by day 28 against 27 of 188 on placebo, an unadjusted hazard ratio of 0.51; after adjustment for baseline differences it was 0.52, with a confidence interval of 0.26 to 1.05 that includes no effect, according to the Lancet Respiratory Medicine paper. Exvastat's own news releases described this as a "significant 49% reduction in mortality", according to a release of August 2021. The WHO added oral imatinib to its Solidarity PLUS trial in more than 600 hospitals in 52 countries in August 2021, according to the WHO.

What the EIC Grant Promised, and What It Bought

The EIC grant agreement for Impentri was signed on 18 February 2021 for a project running from 1 October 2020 to 30 September 2022, with an EU contribution of €1,259,239.09 towards a total cost of €1,798,912.99, according to CORDIS. The objective was that Exvastat would "register and successfully finish 50% of the PhaseII trials in ARDS patients", which, it argued, together with orphan status would open an early route to market. The grant went to the UK company, not the Irish subsidiary named in the EC list, which gives Impentri a single row and names no other beneficiary. Cavalla told Scrip in June 2020 that EU grant money would be routed through the Irish subsidiary because of uncertainty about EU funding for UK projects after Brexit; CORDIS lists only Exvastat Ltd, of Huntingdon, as the beneficiary of both EU projects. The EMA records that the orphan designation was moved to the Irish company in August 2021.

Exvastat announced in May 2021 that it had started the EIC project, a trial of 84 ventilated COVID-19 patients at Indian centres, according to an archived company release. The CORDIS report records the work: drug and placebo vials manufactured and shipped after a nine-month campaign, five Indian sites recruited with five in reserve, approval from the Indian authorities in August 2021 and trial initiation the next month. Then infections in India fell and "there were negligible patients requiring hospital ICU treatment". The registration on ClinicalTrials.gov, sponsored by Exvastat Ltd, is marked withdrawn with zero patients enrolled, because the number of eligible patients was "diminishingly small".

1. Manufacture Impentri and placebo for the trialDeliveredVials shipped, per the CORDIS report.
2. Register the Phase II trial in ARDS patientsDeliveredIndian approval August 2021; registered as NCT04953052.
3. Finish 50% of the Phase II trialNot achievedZero patients enrolled; trial withdrawn.
4. Clinical data for further trials and investmentNot achievedCORDIS: "no project results that can be exploited".
5. Early market entry with orphan statusNot achievedNo marketing application; company dissolved 2025.

The project ran to its planned end date, but its central deliverable, trial data in ARDS patients, was never produced. How much of the €1.26 million was finally paid is not public. Exvastat's accounts show government grants recognised as income of £203,051 in 2020, £703,898 in 2021 and £335,262 in 2022, but these figures combine the EIC grant with Exvastat's share of the IMI grant described below.

The Second EU Grant: A Trial That Ran, and Failed

Exvastat also coordinated a larger EU project with the same name, funded by the Innovative Medicines Initiative (IMI2) from 1 July 2020 to 31 October 2022, with an EU contribution of €3,662,963, of which €536,600.50 went to Exvastat and the rest to Amsterdam UMC, the Academic Medical Center in Amsterdam, KABS and the contract research organisation Orion Santé, according to CORDIS and the IHI project fact sheet. It co-funded CounterCOVID and ran INVENT COVID, the first trial of Impentri itself, in ventilated COVID-19 patients at Dutch intensive care units.

INVENT COVID was stopped in March 2022 after 66 patients because COVID-19 admissions fell, according to its registration. The results, published in Critical Care in June 2023, found that intravenous imatinib "did not reduce EVLWi", the measure of fluid in the lungs, and did not change ventilation time or 28-day mortality: 5 of 33 patients died on imatinib against 6 of 33 on placebo. A benefit appeared only in a post hoc subgroup of 20 patients. The IMI2 project report says the reasons for the difference from CounterCOVID "are not fully understood", and that the team was considering preclinical and clinical studies in other forms of pneumonia, such as influenza. No such study could be found.

The Money

Exvastat's majority owner throughout was Cambridge Innovation Capital, registered as holding more than 50% but less than 75% of the shares since December 2016, according to the Companies House register; Cavalla held more than 25% from August 2019 until April 2021. The company announced further investment from CIC in August 2021, together with the appointment of a chief medical officer, a chief business officer and a chief financial officer, to prepare a Phase III trial "to initiate in 2022", according to the company. The amount was not disclosed; the share premium account in the accounts grew from £1,599,980 at the end of 2020 to £2,772,401 at the end of 2021, and the company raised £700,000 in convertible loan notes on 30 March 2022, according to its filed accounts at Companies House.

The accumulated loss on the balance sheet grew from £1,209,328 at the end of 2019 to £2,531,823 at the end of 2022, and cash fell from £1,540,364 at the end of 2020 to £1,042,943 at the end of 2022. The accounts disagree with themselves on 2019: the original filing showed net assets of £390,691, while the 2020 accounts restated them to £471,255. From 2023 the company filed micro-entity accounts without cash or profit figures.

Exvastat is not among the roughly 320 organisations listed across the 16 pages of the EIC Fund portfolio, which is consistent with its grant-only award.

Why Europe Cared

In 2020 the EU had no authorised treatment for the complication that killed COVID-19 patients. The EIC published a separate list of COVID-19-related winners for its March 2020 cut-off, and IMI picked Exvastat's project as one of eight from 144 applications in its COVID-19 call, according to Scrip. In May 2021 the Commission adopted a therapeutics strategy that aimed to authorise at least three new COVID-19 medicines by October 2021, according to the Commission's representation in Germany. Repurposing a well-known generic drug was a fast and plausible bet, and the problem it addressed outlasts the pandemic: ARDS caused by pneumonia, sepsis and trauma had "no approved pharmacotherapy", Exvastat's website still said in January 2025. But the EIC project was built on a single wave of COVID-19 patients in one country, and when that wave ended, the trial had no fallback that the Indian regulator would accept.

The Verdict

The timing was not the company's fault, and the EIC was right to take risks on COVID-19 therapies in 2020. But the record contains no clinical result from the EIC money, no evidence that Impentri or its orphan designation passed to a new owner, and no company left to develop it. This article is based entirely on public records and published statements, linked throughout; Exvastat's former directors and the EIC were not asked for comment.