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Research: Healthcare
Ultimovacs has been granted Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for UV1 in mesothelioma, marking another step forward for the clinical development of its lead universal, off-the-shelf cancer vaccine. This encouraging regulatory designation follows on the heels of the FDA ODD (October 2023) and Fast Track designation (February 2024) for UV1 in this same indication, which helps set the foundation for a potential Phase III programme. A key benefit of EU ODD is the potential for 10-year market exclusivity, provided UV1 achieves regulatory approval. The EMA decision was based on the recent positive data from the Phase II NIPU trial (reported October 2023) demonstrating a 27% reduction in risk of death with UV1 treatment compared to the standard of care in patients with malignant pleural mesothelioma (MPM). We await the results from the Phase II INITIUM trial in malignant melanoma (MM), the company’s lead indication, in March 2024, which is likely the next catalyst for the company.
Ultimovacs |
Another ODD boosts the off-the-shelf, universal UV1 |
Regulatory update |
Pharma and biotech |
20 February 2024 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has been granted Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for UV1 in mesothelioma, marking another step forward for the clinical development of its lead universal, off-the-shelf cancer vaccine. This encouraging regulatory designation follows on the heels of the FDA ODD (October 2023) and Fast Track designation (February 2024) for UV1 in this same indication, which helps set the foundation for a potential Phase III programme. A key benefit of EU ODD is the potential for 10-year market exclusivity, provided UV1 achieves regulatory approval. The EMA decision was based on the recent positive data from the Phase II NIPU trial (reported October 2023) demonstrating a 27% reduction in risk of death with UV1 treatment compared to the standard of care in patients with malignant pleural mesothelioma (MPM). We await the results from the Phase II INITIUM trial in malignant melanoma (MM), the company’s lead indication, in March 2024, which is likely the next catalyst for the company.
Year |
Revenue (NOKm) |
PBT* |
EPS** |
DPS |
P/E |
Yield |
12/22 |
0.0 |
(167.8) |
(4.90) |
0.0 |
N/A |
N/A |
12/23 |
0.0 |
(189.2) |
(5.50) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(225.8) |
(6.56) |
0.0 |
N/A |
N/A |
12/25e |
1,212.3 |
1,080.7 |
31.41 |
0.0 |
4.68 |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
Ultimovacs has announced that the EMA has granted ODD to UV1 for the treatment of mesothelioma. The benefits of EU ODD include up to 10 years of market exclusivity (post-approval), clinical protocol assistance and reduced regulatory fees. The EMA grants ODD to investigational therapies intended to treat a seriously debilitating or life-threatening condition affecting fewer than five in 10,000 people in the EU. As mesothelioma is an aggressive type of cancer with high mortality and limited treatment options, we believe UV1 has the potential to offer an effective solution, and the receipt of EU ODD marks a noteworthy recognition of UV1’s potential efficacy.
As a reminder, the latest clinical data were the detailed results from NIPU (n=118), which evaluated UV1 in combination with ipilimumab and nivolumab (IPI-NIVO) in MPM patients, compared to IPI-NIVO alone (standard of care). Importantly, overall survival (OS) was 15.4 months in the UV1 treatment arm versus 11.1 months for the control arm, which we view as a highly encouraging result given that OS is widely considered the gold standard of endpoints in oncology trials. UV1 treatment also showed comparable safety/tolerability to IPI-NIVO alone. We note that the US FDA has previously granted ODD to UV1 for the treatment of patients with mesothelioma, as well as Fast Track designation in the same indication.
We continue to believe that the upcoming Phase II INITIUM readouts in MM (expected March 2024) could represent the next most significant catalyst for Ultimovacs. The FDA granted Fast Track designation to UV1 as an add-on therapy to checkpoint inhibitors for the treatment of unresectable or metastatic melanoma in October 2021 and ODD for the treatment of stage IIB–IV melanoma in December 2021. Ultimovacs recently recapped an active FY23, and a detailed discussion (including INITIUM) can be found in our prior update note.
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Research: Consumer
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