Last close As at 05/08/2026
GBP0.23
— 0.00 (0.00%)
Market capitalisation
GBP32m
Research: Healthcare
Sareum has announced that it has filed a clinical trial authorisation (CTA) application for its lead asset, SDC-1801, with the UK Medicines and Healthcare products Regulatory Agency. The announcement marks a key milestone for the company and paves the way for the clinical transition of its flagship TYK2/JAK1 inhibitor targeting the autoimmune space. Subject to regulatory approval, the Phase Ia trial is expected to start in Q4 CY22 and will evaluate the safety and tolerability of SDC-1801 in healthy subjects. If successful, Sareum will initiate a Phase Ib study in psoriasis (PS) patients in 2023. The £4.3m cash balance at the end of June should be sufficient to take SDC-1801 through Phase Ia clinical trials, with the company continuing to assess funding options to further clinical development.
Written by
Sareum Holdings |
SDC-1801 CTA filed in the UK |
Regulatory update |
Pharma and biotech |
29 July 2022 |
Share price performance
Business description
Analysts
Sareum Holdings is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||
Sareum has announced that it has filed a clinical trial authorisation (CTA) application for its lead asset, SDC-1801, with the UK Medicines and Healthcare products Regulatory Agency. The announcement marks a key milestone for the company and paves the way for the clinical transition of its flagship TYK2/JAK1 inhibitor targeting the autoimmune space. Subject to regulatory approval, the Phase Ia trial is expected to start in Q4 CY22 and will evaluate the safety and tolerability of SDC-1801 in healthy subjects. If successful, Sareum will initiate a Phase Ib study in psoriasis (PS) patients in 2023. The £4.3m cash balance at the end of June should be sufficient to take SDC-1801 through Phase Ia clinical trials, with the company continuing to assess funding options to further clinical development.
Year end |
Revenue (£m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/18 |
0.0 |
(1.5) |
(0.06) |
0.0 |
N/A |
N/A |
06/19 |
0.0 |
(1.5) |
(0.05) |
0.0 |
N/A |
N/A |
06/20 |
0.04 |
(1.0) |
(0.03) |
0.0 |
N/A |
N/A |
06/21 |
0.0 |
(1.5) |
(0.05) |
0.0 |
N/A |
N/A |
Source: Company data
The CTA filing of SDC-1801 is a key step in its development plan, particularly given previous delays due to a combination of external (COVID-19) and internal (formulation-related) factors. The most recent example was Sareum’s decision to develop SDC-1801 in capsule form versus the original dry powder suspension in an effort to optimise the formulation and/or administration, which pushed back clinical plans by six months. Sareum has now communicated that it has completed all prerequisites for the clinical trial (including synthesis of the drug substance and capsules in accordance with good manufacturing practice) and that quality control checks are ongoing.
The Phase Ia/Ib study was designed in collaboration with a specialist contract research organisation. The first part of the study (Phase Ia) will be a dose-escalation trial assessing the safety and tolerability of SDC-1801 in healthy volunteers. The trial will also evaluate the effect of SDC-1801 on certain biomarkers of autoimmune disease that could predict efficacy when tested in patients. The study is expected to commence in Q4 CY22, contingent on approval of the CTA filing. If successful, it will be followed by a Phase Ib study enrolling patients with PS (120 subjects across Phase Ia/Ib studies). We note that category leader TYK2 inhibitor deucravacitinib (Bristol Myers Squibb) is expected to receive the FDA’s verdict in September 2022 for moderate to severe PS, which could have a strong read across for SDC-1801.
Sareum’s cash balance at the end of June 2022 was £4.3m, which it estimates is sufficient to complete the Phase Ia clinical trial, although it will require additional funding to further progress the pipeline. Sareum is actively seeking partnerships/out-licensing opportunities and we expect further news on this front in the next few months.
|
|
Research: TMT
As a regionally focused specialist asset manager, Mercia does not expect to experience the same highs and lows in valuations seen in more international growth markets. Mercia offers a defensible UK regional proposition, well aligned to the government’s levelling-up and SME agendas, with its venture portfolio supplemented by private equity and debt funds, investing across the digital media, software, life sciences and engineering sectors. With recurring fee income from FUM of £758m at 31 March 2022, Mercia has demonstrated that its model is sustainably profitable net of central costs. This allows management to offer a progressive dividend policy, with an FY22 dividend yield of 2.7%. Management’s strategy is to grow FUM organically, supplemented by M&A, further building recurring fee income. Mercia’s shares trade at a steep discount to NAV and on an FY22 P/E of just 5x.