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Research: Healthcare
Oxford Cannabinoid Technologies (OCT) has announced the completion of its Phase I trial, a single ascending dose study for its lead drug candidate, OCT461201. The results of the Phase I study demonstrated safety and tolerability across the tested doses and OCT will prepare to proceed to Phase II provided it is able to raise funds in a timely manner. We continue to expect the subsequent Phase II trial to be conducted in patients with neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN) and visceral pain in irritable bowel syndrome (IBS). Based on our current estimates, we project a cash runway to Q424.
Written by
Oxford Cannabinoid Technologies |
Poised to progress to Phase II pending raise |
Clinical update |
Pharma and biotech |
12 October 2023 |
Share price performance
Business description
Analysts
Oxford Cannabinoid Technologies is a research client of Edison Investment Research Limited |
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Oxford Cannabinoid Technologies (OCT) has announced the completion of its Phase I trial, a single ascending dose study for its lead drug candidate, OCT461201. The results of the Phase I study demonstrated safety and tolerability across the tested doses and OCT will prepare to proceed to Phase II provided it is able to raise funds in a timely manner. We continue to expect the subsequent Phase II trial to be conducted in patients with neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN) and visceral pain in irritable bowel syndrome (IBS). Based on our current estimates, we project a cash runway to Q424.
Year end |
Revenue (£m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
04/22 |
0.0 |
(5.1) |
(0.49) |
0.0 |
N/A |
N/A |
04/23 |
0.0 |
(7.0) |
(0.61) |
0.0 |
N/A |
N/A |
04/24e |
0.0 |
(2.9) |
(0.25) |
0.0 |
N/A |
N/A |
04/25e |
0.0 |
(9.9) |
(0.87) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Initial patient dosing of OCT’s Phase I trial of its lead asset (OCT461201) occurred in July 2023. This was a randomised, double-blind, placebo-controlled study using a single ascending dose protocol. The trial recruited 32 healthy volunteers from Simbec Research (part of Simbec-Orion Group) to assess the safety and tolerability of OCT461201 and provide key information on its pharmacokinetic profile to confirm its value as a potential drug. Patients were split into four cohorts of eight and randomised (3:1) to receive either OCT461201 (six patients per cohort) or placebo (two patients per cohort). The final dose for this study was administered on 20 September, followed by a formal review of the clinical data on 2 October.
With the successful completion of this Phase I trial of OCT461201, consistent with management’s previously guided timeline of Q4 CY23, the asset can advance to Phase II readiness. We continue to believe that the subsequent Phase II trials will target two indications: neuropathic pain associated with CIPN and visceral pain in IBS. We note that the CIPN and IBS treatment markets are projected to be worth approximately US$1.17bn by 2028 and US$4.7bn by 2030, respectively. We also understand that there is potential to leverage the Phase I result as a platform to explore additional indications in the future. However, we note that clinical advancement rests on the company’s ability to raise funds in a timely manner. Based on our projections, we estimate that OCT has a cash runway to Q424, as discussed in detail in our recent note.
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