Did the EIC Accelerator Pay Off for Hamlet's Bladder Cancer Drug?

In 2026 a drug derived from a protein in human breast milk entered a Phase III trial for bladder cancer, the stage that can lead to market approval. Hamlet Pharma, a Lund company listed on Spotlight Stock Market and renamed Hamlet BioPharma in 2023, has worked on that drug, Alpha1H, for years. In January 2020 the European Commission picked it in the EIC Accelerator pilot's 8 January 2020 cut-off, where Hamlet Pharma AB of Lund is the only company listed for the HAMLET-BC project, with a grant and no equity. The EU contribution was €2,197,144.59 towards a total cost of €3,138,778 for a project that ran from 1 June 2020 to 30 November 2022, according to CORDIS.

The project set out to "finalise Phase I/II clinical safety and efficacy studies and advance development of Alpha1H towards a Phase III trial (i.e. ready for licensing deal or IPO)". The clinical half of that sentence has largely come true. The commercial half has not: as of early October 2026 Hamlet has signed only a non-binding letter of intent with a partner it does not name, has never reported a krona of sales, and ended its 2025/26 financial year with SEK 5.1 million in cash.

Where Hamlet Stands Now

Hamlet is an active, listed drug developer with no revenue. On 17 September 2026 it announced that patients were being enrolled and treated in its Phase III trial at Motol hospital in Prague. The trial's entry on ClinicalTrials.gov (NCT07804056) confirms an actual start date of 17 September 2026 and a recruiting status: a randomised, open-label study of Alpha1H as a treatment before surgery for low- to intermediate-risk papillary bladder tumours, with 194 participants planned, one listed site in Prague, event-free survival as the primary end point and completion estimated for July 2029.

The company says the study received "regulatory approval from the European Medicines Agency (EMA)" on 29 June 2026, in a release repeated by the news agency Finwire. That wording is loose. Under EU rules, "EU Member States and EEA countries assess applications for clinical trial authorisations at national level", while the EMA runs the submission system, according to the EMA. The registry entry carries an EU trial number (2026-525531-16-00), so the trial was authorised through that system; it is not an EMA approval of the drug.

The Technology: A Milk Protein That Kills Tumour Cells

HAMLET stands for "Human Alpha-lactalbumin Made LEthal to Tumour cells". Alpha-lactalbumin, a protein in human breast milk, kills tumour cells when it is partly unfolded and bound to oleic acid, a fatty acid, according to the company's papers and the CORDIS objective. Alpha1H is the synthetic successor: a 39-amino-acid peptide from the protein, bound to oleic acid, which can be made in bulk at drug quality. In a paper in Nature Communications in June 2021, the team reported an interim analysis of a single-centre, placebo-controlled, double-blind Phase I/II trial in which the drug, instilled into the bladder, "triggers massive shedding of tumor cells and the tumor size is reduced but no drug-related side effects are detected".

Non-muscle invasive bladder cancer is today treated by cutting tumours out through the urethra, followed by chemotherapy or BCG immunotherapy instilled into the bladder, and the HAMLET-BC report puts recurrence at 50% even after complete removal. Hamlet's pitch is a treatment given in the weeks between diagnosis and surgery, when patients usually get nothing, which the company says has "currently there are no therapy options available". A later paper in Cancer Medicine in 2024 reported a complete or partial response in 88% of tumours treated with an 8.5 mM dose, against 47% at 1.7 mM, with no drug-related side effects except local irritation. Both papers are written by Svanborg's group with the Prague clinicians who ran the trial; no independent group has reported clinical results.

What HAMLET-BC Promised, and What CORDIS Shows

The EIC money did not all go to Hamlet. CORDIS lists Linnane Pharma AB of Malmö as a linked third party with a net EU contribution of €201,979.16, leaving €1,995,165.43 for Hamlet. Hamlet's own 2021/22 year-end report gives a different split, saying 252 KEUR of the grant "belongs to Linnane Pharma". Linnane is not an outsider: a February 2025 release calls it a major Hamlet shareholder in which Svanborg is the majority shareholder. Hamlet bought Linnane Projects AB, a tuberculosis project, from Linnane in 2023, proposed in 2025 to license patent rights for a related substance, BAMLET, to Linnane in a related-party deal put to shareholders, and in March 2026 named Linnane as co-developer of Alpha1H in its letter of intent with a German partner. How the future proceeds from Alpha1H would be shared between Hamlet's shareholders and Linnane is not public.

On delivery, the record is strong for the clinic and thin for the market. The project's final periodic report lists the completion of the Phase I/II study, a dose-escalation extension with "a dramatic increase in the tumor response", large-scale GMP production with a new manufacturing partner, and ongoing talks with European and US regulators. Hamlet's 2021/22 report describes a 24-month project; CORDIS shows 30 months. The Commission called the results "exceptional" in its final review, according to Hamlet, which said in April 2023 that a final payment of "about 300 000 EUR" would follow; its 2021/22 report had put the outstanding amount at 110 KEUR. The review itself is not public.

1. Finalise the Phase I/II safety and efficacy studyDeliveredInterim results in Nature Communications (2021); final report filed, per the CORDIS report.
2. Dose-finding studiesDeliveredDose escalation to 8.5 and 17 mM, published in Cancer Medicine (2024).
3. GMP production of Alpha1H at scaleDeliveredNew production partner during the project; Phase III-quality drug released to trial sites in June 2026.
4. Advance Alpha1H to a Phase III trialLateFDA cleared the IND in July 2023; Phase III began in September 2026, almost four years after the project ended.
5. Licensing deal for Alpha1HNot achievedOnly a non-binding letter of intent (March 2026); no definitive agreement announced.

What Hamlet Has Achieved Since the Award

The regulatory steps came after the EIC project closed. The US Food and Drug Administration cleared Hamlet's investigational new drug application in July 2023 and granted Fast Track designation in November 2023, which allows more frequent contact with the agency. In August 2025 Hamlet announced the completion of what it calls a Phase II study of about 60 patients, with 80% of tumours responding and a 59% average reduction in tumour size in the high-dose group. Those final figures are the company's; it said they would be published in peer-reviewed journals. The only earlier Alpha1H trial on ClinicalTrials.gov, NCT03560479, is registered as a Phase I/II study at Motol University Hospital with 52 patients estimated; its record was last updated in August 2020 and its status is shown as unknown.

In June 2026 Hamlet signed a clinical trial agreement with the University of Iowa to test Alpha1H in carcinoma in situ, an aggressive form of the disease; the release says the research is funded in part by Hamlet. A July 2026 update said due diligence by the German company was complete and commercial negotiations were under way. No partner has been named.

The company also changed shape. It absorbed SelectImmune Pharma, another Svanborg company, in a merger announced in March 2023, took the name Hamlet BioPharma in August 2023, and now also develops non-antibiotic treatments for urinary tract infections and bladder pain. The register data aggregated by North Data shows both names under organisation number 5565688958 at the Lund address, with no insolvency notice. Sources differ on the company's age: its 2015 listing prospectus gives 29 March 1999 as the date of incorporation, while the company profile on the MFN news service says it was founded in 2015. The chief executive post has changed hands often: Martin Erixon from June 2022, a successor announced in June 2023 who left in October 2023, Svanborg herself from February 2025, and the former finance chief Jakob Testad after the December 2025 annual meeting, as planned in November 2025.

The Money

Hamlet has never reported net sales. Its yearly loss rose from SEK 7.7 million in 2020/21 to SEK 55.6 million in 2025/26, and the EU grant, booked as other operating income of SEK 9.3 million and SEK 10.0 million in the two years it mainly covered, softened the early figures. The 2025/26 year-end report shows an EBITDA loss of SEK 45.6 million, equity of SEK 19.7 million and cash of SEK 5.1 million on 30 June 2026. The company says it has spent about SEK 300 million to date on three successful Phase II studies.

The money has come from Spotlight shareholders in small slices: a SEK 46.7 million rights issue in February 2024, in which the main owner said she could not take part; SEK 26.8 million from 15 private investors and family offices in a directed issue in December 2024; a units issue of just over SEK 30 million in 2025; and SEK 8.5 million and SEK 25.7 million from warrants in March and August 2026. A further 6,976,744 warrants could bring in about SEK 69.8 million in January 2028 if the share price makes them worth exercising. None of these announcements names a venture capital fund or a pharmaceutical company among the investors, and the company does not appear in any of the 326 entries on the 17 pages of the EIC Fund portfolio.

Why Europe Should Care

Cancer is one of the EU's declared health priorities. Europe's Beating Cancer Plan, with a €4 billion budget, covers "prevention; early detection; diagnosis and treatment; quality of life of cancer patients and survivors". Bladder cancer fits the treatment pillar: the HAMLET-BC objective on CORDIS cites a recurrence rate of 70% and treatment costs of more than €4.9 billion a year in Europe, figures supplied by the company. A low-toxicity drug that shrinks tumours before surgery would matter to patients who now face repeated operations. It is also a European candidate, developed in Lund and tested in Prague.

The Verdict

Hamlet BioPharma has not been asked for comment for this article. It is based entirely on public records, company statements, trial registries and EU project data, linked throughout.