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Research: Healthcare
Ultimovacs has confirmed that top-line results for the Phase II INITIUM trial (investigating lead candidate UV1 in combination with ipilimumab and nivolumab as first-line treatment for malignant melanoma, n=156) will be reported as planned in March 2024. This is a positive indicator that the trial is progressing, in our view, as the timeline had previously been pushed back twice (to H223 and H124) due to patients taking longer than expected to experience disease progression. Management has also confirmed that, while 70 progression events have not yet occurred, 18 months of follow-up for the last enrolled patient has been completed, thus enabling data analysis to commence. We view the latest announcement as an encouraging sign and believe that the upcoming INITIUM readout could be a significant catalyst for investor attention.
Written by
Ultimovacs |
INITIUM: March 2024 top-line timeline confirmed |
Clinical update |
Pharma and biotech |
17 January 2024 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has confirmed that top-line results for the Phase II INITIUM trial (investigating lead candidate UV1 in combination with ipilimumab and nivolumab as first-line treatment for malignant melanoma, n=156) will be reported as planned in March 2024. This is a positive indicator that the trial is progressing, in our view, as the timeline had previously been pushed back twice (to H223 and H124) due to patients taking longer than expected to experience disease progression. Management has also confirmed that, while 70 progression events have not yet occurred, 18 months of follow-up for the last enrolled patient has been completed, thus enabling data analysis to commence. We view the latest announcement as an encouraging sign and believe that the upcoming INITIUM readout could be a significant catalyst for investor attention.
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.
As per the announcement, top-line results for INITIUM will be shared in March 2024, consistent with the latest guided timeline for this trial. The study protocol was amended in Q423 to permit a readout after all patients have been followed for 18 months, or after 70 patients have progressed or died. While 70 disease progression events have not yet occurred, the 18-month follow-up has been reached for the last patient enrolled, allowing data analysis to commence in accordance with the agreed protocol amendment. Overall, patients have been followed up for a range of 18–42 months, with an estimated median observation time of c 24 months; it was noted that patients will be followed for survival for two years after the primary endpoint analysis has been completed. We highlight that the adjusted study protocol is not expected to affect the integrity of the statistical analysis planned for INITIUM, which remains set up with 80% statistical power. As melanoma is Ultimovacs’ priority indication for UV1 and since proof-of-concept has been demonstrated in this indication in the Phase I UV1-103 trial (in combination with pembrolizumab), we believe the much-anticipated results from INITIUM may represent the most significant upcoming catalyst for the company.
We remind readers that the Ultimovacs’ primary asset is its universal cancer vaccine UV1, currently being assessed in five Phase II and two Phase I studies. The INITIUM trial is assessing the efficacy and safety of UV1 in combination with nivolumab and ipilimumab (IPI-NIVO), compared to IPI-NIVO alone (the current standard of care), as a potential first-line treatment for patients with unresectable or metastatic malignant melanoma. The primary efficacy measure is progression-free survival, with overall survival, objective response rate and duration of response as secondary objectives. We note that 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 Orphan Drug Designation for the treatment of stage IIB–IV melanoma in December 2021.
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Research: Real Estate
Having previously updated on Picton Property Income’s H124 results, we are re-instating forecasts following the cessation of merger discussions with UKCM. In a challenging environment, H124 financial performance was resilient, supporting fully covered DPS. Meanwhile, the company continues to believe that there are strategic and financial benefits to combining complementary businesses, particularly within an internal management structure, including economies of scale and enhanced earnings.