Currency in NOK
Last close As at 09/06/2023
NOK82.40
▲ −34.60 (−29.57%)
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NOK2,834m
Ultimovacs’ lead therapeutic vaccine candidate, UV1, continues to display positive signs of clinical efficacy, this time in the form of long-term patient survival from the ongoing Phase I (NCT03538314) study in advanced unresectable and metastatic malignant melanoma patients. The trial is investigating UV1 in combination with Merck’s immune checkpoint inhibitor (ICI) pembrolizumab (Keytruda) in the first-line setting. The three-year overall survival (OS) rate from patients in cohort one of the study was 71% (12/17). This result builds on the consistently high OS rates already observed from the trial: 85% (17/20) after one year and 80% (16/20) after two-year follow-up. We believe these latest data not only highlight the clinical utility of UV1 in melanoma patients, but also provide encouraging signs for further indications which UV1 is being investigated in the clinic. We continue to value Ultimovacs at NOK7.2bn or NOK209/share.
Ultimovacs |
UV1 encouraging three-year survival data |
Clinical trial update |
Pharma and biotech |
6 October 2022 |
Share price performance Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
Ultimovacs’ lead therapeutic vaccine candidate, UV1, continues to display positive signs of clinical efficacy, this time in the form of long-term patient survival from the ongoing Phase I (NCT03538314) study in advanced unresectable and metastatic malignant melanoma patients. The trial is investigating UV1 in combination with Merck’s immune checkpoint inhibitor (ICI) pembrolizumab (Keytruda) in the first-line setting. The three-year overall survival (OS) rate from patients in cohort one of the study was 71% (12/17). This result builds on the consistently high OS rates already observed from the trial: 85% (17/20) after one year and 80% (16/20) after two-year follow-up. We believe these latest data not only highlight the clinical utility of UV1 in melanoma patients, but also provide encouraging signs for further indications which UV1 is being investigated in the clinic. We continue to value Ultimovacs at NOK7.2bn or NOK209/share.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(120.6) |
(3.98) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(164.7) |
(5.09) |
0.0 |
N/A |
N/A |
12/22e |
0.0 |
(213.5) |
(6.24) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(219.1) |
(6.40) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As a reminder, the UV1-103 study is a US-based Phase I trial evaluating the safety, tolerability and clinical response of the UV1 combination treatment regimen. The study consists of two patient cohorts, cohort one (n=20) and cohort two (n=10), each receiving different doses of UV1 adjuvant (37.5 µg versus 75 µg). The UV1-103 trial had previously met its primary endpoints for safety and tolerability and the latest data from cohort one patients demonstrate the long-term clinical efficacy of UV1. Of note, the three-year OS rate from the KEYNOTE-006 study investigating pembrolizumab as a monotherapy in first-line patients with metastatic melanoma was 51%. This further underpins our view that cancer vaccines, in combination with ICIs, are critical to delivering therapeutic benefits.
Efficacy data from the two patient cohorts combined (n=30) have so far reported objective response rates of 57%, complete response rates of 33%, median progression-free survival of 18.9 months and OS rates after 12 and 24 months of 87% and 73%, respectively. Three-year follow-up data from the combined patient group are expected in H223 and the study will continue to assess OS in patients for up to five years.
Additionally, these latest OS data provide encouraging signs for the ongoing Phase II INITIUM (NCT04382664) trial investigating UV1 in combination with ICIs nivolumab and ipilimumab as a first-line treatment in patients with advanced malignant melanoma. Patient enrolment was completed in June 2022, with top-line PFS data expected in H123, which we see as a significant catalyst.
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During FY22 Quadrise signed agreements progressing the three key projects with MSC Shipmanagement (MSC), its client in Morocco and Valkor in Utah, following which it expects trials to start soon. Successful delivery on these existing projects should enable Quadrise to become revenue generating during FY23 (H1 CY23), subject to the timely completion of commercial project agreements.
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