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Last close As at 02/06/2023
NOK122.20
▲ 2.20 (1.83%)
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NOK4,203m
Ultimovacs is forging ahead with its busy clinical pipeline as the first patient is treated in the fifth Phase II study, LUNGVAC. The LUNGVAC trial (NCT05344209) is investigating the company’s lead cancer vaccine candidate, UV1, in combination with immune checkpoint inhibitor (ICI) pembrolizumab (Keytruda) in patients (n=138) with advanced or metastatic non-small cell lung cancer (NSCLC). Top-line results are expected from the study by end CY24. The company had communicated that first patient enrolment was expected in Q322; however, we do not see this slight delay as having a significant impact on the overall trial timelines. NSCLC remains one of the largest solid tumour indications where unmet medical needs still exist, and with pembrolizumab sales estimated to reach c US$5bn by 2028 in this indication (source: EvaluatePharma), we feel Ultimovacs may be able to capture a segment of this sizeable market. We continue to value Ultimovacs at NOK7.2bn or NOK209/share.
Ultimovacs |
First patient in Phase II LUNGVAC study |
Clinical trial update |
Pharma and biotech |
25 October 2022 |
Share price performance Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
Ultimovacs is forging ahead with its busy clinical pipeline as the first patient is treated in the fifth Phase II study, LUNGVAC. The LUNGVAC trial (NCT05344209) is investigating the company’s lead cancer vaccine candidate, UV1, in combination with immune checkpoint inhibitor (ICI) pembrolizumab (Keytruda) in patients (n=138) with advanced or metastatic non-small cell lung cancer (NSCLC). Top-line results are expected from the study by end CY24. The company had communicated that first patient enrolment was expected in Q322; however, we do not see this slight delay as having a significant impact on the overall trial timelines. NSCLC remains one of the largest solid tumour indications where unmet medical needs still exist, and with pembrolizumab sales estimated to reach c US$5bn by 2028 in this indication (source: EvaluatePharma), we feel Ultimovacs may be able to capture a segment of this sizeable market. 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.
NSCLC represents up to c 85% of all lung cancer in the United States with significant clinical burden for patients. The LUNGVAC trial is a multicentre, randomised, open-label trial assessing the safety and efficacy of UV1 in two sub-populations of NSCLC patients with adenocarcinoma (c 40% of cases) or squamous tumours (c 30% of cases). Patients must also express programmed death-ligand 1 (PD-L1), a key predictive biomarker for response to ICI therapy, in at least half of their tumour cells. The company recently reported efficacy in patients treated with the UV1/pembrolizumab combination, even in patients with low levels of PD-L1. While read across between indications may not correlate directly, we view this as an encouraging sign for the LUNGVAC combination regimen.
The primary endpoint for the LUNGVAC study will be progression-free survival with key secondary endpoints including overall survival, response rate, duration of response and safety. Top-line data readouts are anticipated by end 2024 but management will provide further guidance in the company’s Q422 report.
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Sareum’s FY22 results (to end-June 2022) provided both a financial and operational update on the company’s progress with its developmental pipeline. Encouraging progress has been made with SDC-1801 and the company has filed an exploratory clinical trial application (CTA) to initiate a UK-based Phase Ia/b study. Subject to regulatory approval, management intends for Phase Ia of the trial to commence in Q4 of CY22. Additionally, the company continues to progress its preclinical pipeline through the development of its immunoncology asset SDC-1802 as well as explore strategic options for its clinical oncology asset SRA737. With a gross cash balance of £4.3m at the end of FY22, Sareum expects to have sufficient funding to take SDC-1801 through the Phase Ia portion of the study. We see regulatory approval to initiate the SDC-1801 Phase Ia trial as the next major catalyst for Sareum.
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