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Research: Healthcare
Ultimovacs has announced an amendment to the Phase II INITIUM trial, assessing lead cancer vaccine UV1 in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab for the first-line treatment of malignant melanoma. The amendment allows the company to commence data analysis from mid-January 2024 and share top-line results in March or April 2024. This practical and proactive approach assists in unlocking the value of the programme (out-licensing) or progressing to pivotal studies if the data are positive. Top-line results were initially expected in H123, but the timeline was pushed back twice to H223 and H124 as patients were taking longer than expected to experience disease progression. We view this as a possible positive indicator for trial success (although not definitive as it is possible that the control arm may be experiencing slower than expected progression).
Written by
Ultimovacs |
Line of sight on INITIUM top-line readout |
Clinical update |
Pharma and biotech |
2 November 2023 |
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Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced an amendment to the Phase II INITIUM trial, assessing lead cancer vaccine UV1 in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab for the first-line treatment of malignant melanoma. The amendment allows the company to commence data analysis from mid-January 2024 and share top-line results in March or April 2024. This practical and proactive approach assists in unlocking the value of the programme (out-licensing) or progressing to pivotal studies if the data are positive. Top-line results were initially expected in H123, but the timeline was pushed back twice to H223 and H124 as patients were taking longer than expected to experience disease progression. We view this as a possible positive indicator for trial success (although not definitive as it is possible that the control arm may be experiencing slower than expected progression).
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 |
(214.8) |
(6.24) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(227.9) |
(8.08) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
Management announced an amendment to the INITIUM clinical trial protocol that will enable the data analysis to be based on the minimum 18-month follow-up period of all evaluable patients. Ultimovacs has conferred with the relevant regulatory bodies and the adjustment is in light of the slower than anticipated disease progression.
The original trial protocol specified that data analysis would be conducted once cancer progression was observed in 70 of 156 patients (referred to as the number of endpoints). With patients taking longer than anticipated to experience disease progression, the regulatory authorities have agreed to allow a cut-off from mid-January 2024, with the analysis performed with less than 70 endpoints. The adjustment is not expected to affect the integrity of the statistical analysis planned for INITIUM and remains set up with 80% statistical power. With what we estimate to be approximately seven or eight fewer endpoints, Ultimovacs will need to demonstrate a slightly lower hazard ratio (HR) of 0.726 for a statistically significant result, slightly lower than the previously defined HR of 0.736 with the originally planned 70 endpoints. While this represents a marginally more difficult outcome to achieve, management emphasised the importance of maintaining the integrity of the planned statistical analysis.
The primary efficacy measure of INITIUM is progression-free survival, with secondary objectives of overall survival, objective response rate and duration of response. The first patient was enrolled in June 2020 and the trial completed enrolment in July 2022. 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. In our view, the much-anticipated results from INITIUM represent the most significant upcoming catalyst for Ultimovacs.
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Research: TMT
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