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Research: Healthcare
Ultimovacs has announced that the US FDA has granted orphan drug designation (ODD) to its cancer vaccine, UV1, for the treatment of mesothelioma. This is a positive development as the orphan designation is based on initial clinical data from the investigator-led Phase II NIPU clinical trial, which did not meet its primary end point of progression-free survival (PFS) in June 2023; however, it indicated a positive trend in overall survival (OS) in the UV1 arm. While the company is gearing up to share updated dataset (especially OS data) for NIPU at the upcoming ESMO Congress from 20–24 October, we believe the ODD indicates UV1’s potential in mesothelioma and might be helpful in further discussions with the US FDA. In our view, the upcoming readouts from the ongoing Phase II trials, including the next INITIUM (malignant melanoma) top-line results in H124, represent major catalysts for the company.
Written by
Ultimovacs |
UV1 ODD a sign of positive things to come |
Regulatory update |
Pharma and biotech |
10 October 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 the US FDA has granted orphan drug designation (ODD) to its cancer vaccine, UV1, for the treatment of mesothelioma. This is a positive development as the orphan designation is based on initial clinical data from the investigator-led Phase II NIPU clinical trial, which did not meet its primary end point of progression-free survival (PFS) in June 2023; however, it indicated a positive trend in overall survival (OS) in the UV1 arm. While the company is gearing up to share updated dataset (especially OS data) for NIPU at the upcoming ESMO Congress from 20–24 October, we believe the ODD indicates UV1’s potential in mesothelioma and might be helpful in further discussions with the US FDA. In our view, the upcoming readouts from the ongoing Phase II trials, including the next INITIUM (malignant melanoma) top-line results in H124, represent major catalysts for the company.
Year end |
Revenue |
PBT* (NOKm) |
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.
The latest ODD for UV1 for mesothelioma is encouraging given the top-line results for the NIPU trial (mesothelioma; n=118) in June were initially received negatively. It also broadens the scope of the existing ODD for UV1 in malignant melanoma, received in December 2021. Ultimovacs reported initial clinical data from the Phase II NIPU study investigating the company’s cancer vaccine, UV1, as a second-line treatment of malignant pleural mesothelioma (MPM) in June 2023. We note that the NIPU study is sponsored by Oslo University Hospital with support from BristolMyers Squibb and Ultimovacs. While the study did not meet its primary endpoint of PFS following assessment conducted by a central independent review committee, local assessments at the study hospitals performed by specialist radiographers measured a statistically significant improvement in PFS. Importantly, a positive trend in overall survival was observed in the UV1 arm of the NIPU study.
We expect Ultimovacs to present more mature and updated overall survival (OS) data at the upcoming European Society for Medical Oncology Congress in late October, which, if favourable, might further confirm the OS benefit in the UV1 arm. We emphasise that NIPU study assesses UV1 in second-line treatment for MPM, where standard-of-care is not yet established, with fewer treatment options, mainly related to palliative care. Hence, it represents an important therapeutic opportunity for the company.
Apart from NIPU trial, Ultimovacs is conducting additional Phase II studies in patients with malignant melanoma (INTIUM), head and neck cancer (FOCUS), ovarian cancer (DOVACC) and non-small cell lung cancer (LUNGVAC). The topline data from the malignant melanoma and head and neck cancer trials are anticipated within a year’s timeframe and represent the next key catalysts for the company.
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Research: Healthcare
Immix has announced encouraging updated clinical data for NXC-201, a B cell maturation antigen (BCMA) targeting CAR-T therapy, which is being developed by majority-owned subsidiary Nexcella, in both multiple myeloma (MM) and amyloid light chain amyloidosis (ALA). The updated data for MM patients indicate an overall response rate (ORR) of 95%, notably higher than comparable CAR-T trials for MM, and for ALA show a 100% ORR in heavily pre-treated patients. The therapy has the potential to be the first outpatient CAR-T therapy, which would address many of the current CAR-T challenges with cost and access. With its recent $9.6m raise, we estimate Immix has an operating cash runway into Q424, from Q224 previously. Adjusting for the pro-forma cash of $22.2m, our valuation for Immix increases to $90.7m or $4.2/share (from $81.1m or $5.0/share).