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Research: Healthcare
Ultimovacs has announced that patient enrolment has been completed for FOCUS, the Phase II clinical trial assessing UV1 in combination with pembrolizumab for the treatment of head and neck cancer. The anticipated H224 top-line results, including overall survival (OS), represents a notable catalyst for the company as it comes amid several crucial readouts from Ultimovacs’s ongoing Phase II trials investigating the company’s lead cancer vaccine in various cancer indications. The INITIUM study is the next expected update (H223), assessing UV1 in combination with ipilimumab and nivolumab for the treatment of metastatic malignant melanoma.
Written by
Ultimovacs |
FOCUS - first in series of upcoming catalysts |
Clinical update |
Pharma and biotech |
4 August 2023 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced that patient enrolment has been completed for FOCUS, the Phase II clinical trial assessing UV1 in combination with pembrolizumab for the treatment of head and neck cancer. The anticipated H224 top-line results, including overall survival (OS), represents a notable catalyst for the company as it comes amid several crucial readouts from Ultimovacs’s ongoing Phase II trials investigating the company’s lead cancer vaccine in various cancer indications. The INITIUM study is the next expected update (H223), assessing UV1 in combination with ipilimumab and nivolumab for the treatment of metastatic malignant melanoma.
Year end |
Revenue |
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 |
(210.8) |
(6.13) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(277.9) |
(8.08) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
Ultimovacs has provided an update on the FOCUS trial, stating that patient enrolment has been completed (n=75) and that the last patient has been dosed. This is a Phase II randomised study being conducted across ten sites in Germany to assess the potential benefit of UV1 as an add-on to standard of care treatment with immune checkpoint inhibitor (ICI) pembrolizumab, versus pembrolizumab alone. Topline results include OS with a minimum follow-up of 12 months, as well as progression-free survival (PFS), and are expected in H224, pushed back slightly from prior guidance of H124. We note that Ultimovacs is targeting first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The head and neck cancer market is projected to be worth around $4.7bn by 2028 (according to EvaluatePharma) and, with HNSCC accounting for over 90% of these cases, we believe that the readouts from FOCUS could be a major catalyst for Ultimovacs.
FOCUS is the third of five Phase II trials evaluating UV1 in various cancer indications, in combination with various ICIs. In June 2023, Ultimovacs shared results from the NIPU study (metastatic pleural mesothelioma) and, while the study did not meet the primary endpoint of PFS, a positive trend was observed in OS for the UV1 arm; readers can access our detailed discussion on the outcome of this trial here. Full data from NIPU, including OS, will be shared in autumn. In our view, the next most significant near-term catalyst for investor attention will be readouts from the INITIUM study (metastatic malignant melanoma). Patient enrolment (n=156) was completed in July 2022 and top-line results are anticipated in H223. Slightly further on the horizon are readouts from the DOVACC (ovarian cancer) and LUNGVAC (non-small cell lung cancer) studies; top-line results from these trials are expected in H224 and H225, respectively.
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