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Research: Healthcare
Ultimovacs has received FDA Fast Track designation for its lead cancer vaccine, UV1, as a potential treatment for mesothelioma and builds on the Orphan Drug designation (ODD) already received in this indication. The designation offers a potentially accelerated route to market (if the clinical data continue to be supportive) as Ultimovacs progresses its universal vaccine in combination with checkpoint inhibitors across five indications. This regulatory decision was based on the positive results of the Phase II NIPU trial (reported October 2023), which showed a 27% reduction in risk of death with UV1 treatment compared to control. While management carefully evaluates an optimal path forward (Phase III programme) in mesothelioma, the most significant near-term catalyst remains the Phase II INITIUM results in malignant melanoma (expected March 2024). The company is scheduled to release FY23 earnings on 14 February and will likely provide an update then.
Written by
Ultimovacs |
FDA Fast Track boosts confidence in UV1 |
Regulatory update |
Pharma and biotech |
6 February 2024 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has received FDA Fast Track designation for its lead cancer vaccine, UV1, as a potential treatment for mesothelioma and builds on the Orphan Drug designation (ODD) already received in this indication. The designation offers a potentially accelerated route to market (if the clinical data continue to be supportive) as Ultimovacs progresses its universal vaccine in combination with checkpoint inhibitors across five indications. This regulatory decision was based on the positive results of the Phase II NIPU trial (reported October 2023), which showed a 27% reduction in risk of death with UV1 treatment compared to control. While management carefully evaluates an optimal path forward (Phase III programme) in mesothelioma, the most significant near-term catalyst remains the Phase II INITIUM results in malignant melanoma (expected March 2024). The company is scheduled to release FY23 earnings on 14 February and will likely provide an update then.
Year |
Revenue (NOKm) |
PBT* |
EPS** |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(164.7) |
(5.09) |
0.0 |
N/A |
N/A |
12/22 |
0.0 |
(167.8) |
(4.89) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(191.5) |
(5.57) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(235.9) |
(6.86) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
The latest clinical data for UV1 were the detailed results from the Phase II NIPU trial (n=118), which investigated UV1 in combination with ipilimumab and nivolumab (IPI-NIVO) in patients with malignant pleural mesothelioma, compared to IPI-NIVO alone (current standard of care). A key highlight was the overall survival data, the gold standard of endpoints in oncology trials, reported as 15.4 months in the UV1 treatment arm versus 11.1 months for the control arm. Treatment with UV1 was also determined to have a comparable safety profile to IPI-NIVO alone.
Fast Track designation has now been granted to UV1 in combination with IPI-NIVO for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival. Benefits of Fast Track designation include more frequent interactions with the FDA to expedite the approval process, as well as a rolling review for its market application. We believe this marks an important recognition of UV1’s potential efficacy. While the NIPU trial was based on UV1 treatment in the second-line setting, management is evaluating the best way to optimise the potential for UV1 in patients with mesothelioma, which we believe could include a Phase III programme focused on the first-line setting that would represent a greater commercial opportunity. We note that the FDA had previously granted ODD to UV1 for the treatment of patients with mesothelioma. We believe this provides a strong foundation for further clinical development in this challenging indication and expect an update from management on a potential Phase III programme once more material decisions have been made.
Ultimovacs’ lead indication for UV1 is malignant melanoma and the upcoming Phase II INITIUM readouts (March 2024) could represent a significant catalyst. 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.
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Research: Industrials
In FY23 Information Services Corporation (ISC) remained on a positive trajectory of securing new contracts and customers, despite prevailing macroeconomic headwinds and a subdued Canadian property market. We expect this momentum to continue in FY24, bolstered by the Services division, the key organic engine of the group. Management has reaffirmed FY23 revenue and adjusted EBITDA guidance of C$207–212m (Edison: C$210m) and C$71–76m (Edison: C$75m), respectively. In addition, FY24 guidance has been introduced; our FY24e adjusted EBITDA estimate of C$90m falls within the guided range of C$83–91m, while our conservative FY24e revenue estimate of C$230m is marginally below the guided C$240–250m range. We will update our estimates following the release of FY23 results in early March.