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Research: Healthcare
Oxford Cannabinoid Technologies (OCT) has shared its FY23 results and summarised its ongoing activities. OCT completed preclinical research for OCT461201 (programme 1) and in July 2023 the first healthy volunteer was dosed in the Phase I safety study; results are expected in Q3 CY23. Management believes this programme will be Phase II ready by Q4 CY23, and plans to target neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN) and visceral pain in irritable bowel syndrome (IBS). OCT also completed preclinical research for OCT130401 (programme 2) and announced the company’s expansion into oncology (programme 4). As we push out our launch timelines for programme 1 to FY30 (FY29 previously; FY27 estimated by management) to reflect the current halt in development, update net cash and roll forward the model, our valuation adjusts to £25.3m or 2.6p per share (£26.1m or 2.7p/share previously). In line with management guidance, we have updated our cash runway to Q424 (Q124 previously) but emphasise the imminent need to raise funds to advance clinical activities.
Written by
Oxford Cannabinoid Technologies |
Clinical headway rests on funding |
FY23 results |
Pharma and biotech |
12 September 2023 |
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Oxford Cannabinoid Technologies is a research client of Edison Investment Research Limited |
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Oxford Cannabinoid Technologies (OCT) has shared its FY23 results and summarised its ongoing activities. OCT completed preclinical research for OCT461201 (programme 1) and in July 2023 the first healthy volunteer was dosed in the Phase I safety study; results are expected in Q3 CY23. Management believes this programme will be Phase II ready by Q4 CY23, and plans to target neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN) and visceral pain in irritable bowel syndrome (IBS). OCT also completed preclinical research for OCT130401 (programme 2) and announced the company’s expansion into oncology (programme 4). As we push out our launch timelines for programme 1 to FY30 (FY29 previously; FY27 estimated by management) to reflect the current halt in development, update net cash and roll forward the model, our valuation adjusts to £25.3m or 2.6p per share (£26.1m or 2.7p/share previously). In line with management guidance, we have updated our cash runway to Q424 (Q124 previously) but emphasise the imminent need to raise funds to advance clinical activities.
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.
OCT461201 Phase I trial under way
The first-in-human, randomised, double-blind, placebo-controlled, dose-escalation trial is ongoing, with the first participant dosed in July 2023. The study will recruit 32 healthy volunteers to assess safety and tolerability. Patients are split into four cohorts of eight and randomised (3:1) to receive OCT461201 (six patients per cohort) or placebo (two patients per cohort); results are on track for Q3 CY23. We expect the subsequent Phase II trial to involve CIPN and IBS patients, but OCT may use the Phase I results as a platform to explore additional indications.
Financing required for clinical advancement
With net cash at £2.3m at end-FY23 and the current hold on clinical activities (except OCT461201), we expect OCT to raise funds in H224, with an anticipated cash burn rate of £2.9m in FY24 (£11.3m previously). We forecast a total fund raise of £40m through FY26 (£15m in both FY24 and FY25; £10m in FY26), modelled as illustrative debt. We highlight that the fund raise remains critical to the clinical advancement of OCT’s clinical assets, including the Phase II trial for OCT461201.
Valuation: £25.3m or 2.6p per share
Our valuation adjusts to £25.3m or 2.6p/share (£26.1m or 2.7p/share previously). The decline is driven by pushing out our product launch timelines for programme 1 to FY30, and the combined effect of model roll forward, revision of FY24 estimates and updated net cash balance. We value OCT based on a risk-adjusted net present value (rNPV) using a 12.5% discount rate, including OCT461201 in IBS and CIPN.
An expandable pipeline comprised of four programmes
OCT is focused on the development of new chemical entities (NCEs), phytocannabinoids (synthetic plant-derived cannabinoids) and cannabinoid derivatives. The company has a drug development pipeline comprised of four programmes, targeting pain and oncology indications (Exhibit 1).
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Exhibit 1: OCT’s drug development pipeline |
|
|
Source: Oxford Cannabinoid Technologies website |
OCT461201 (programme 1): this lead asset is a cannabinoid receptor type 2 (CB2) selective NCE agonist. OCT is focused on neuropathic pain associated with CIPN and visceral pain in IBS, as initial indications, which have treatment markets projected to be worth $1.17bn by 2028 and $4.7bn by 2030, respectively. Preclinical work was completed in Q4 CY22, providing encouraging indicators of efficacy in neuropathic pain and IBS animal disease models (further details in our initiation note). Management has stated that results from the Phase I trial are expected in Q3 CY23, and that the project should be Phase II ready by Q4 CY23, consistent with prior guided timelines.
OCT130401 (programme 2): OCT’s second asset is an inhaled phytocannabinoid drug/device combination. It has been designed for the treatment of trigeminal neuralgia, a severe neuropathic facial pain indication colloquially referred to as the ‘Suicide Disease’ as it is associated with sudden chronic pain in the head and face, and has been likened to feeling a sharp shooting pain or electric shock in the jaw, teeth and gums. We note that orphan designation has been granted for this asset, enabling seven years of market exclusivity in the United States, and 10 years in Europe and Japan, if successful with regulatory approval. OCT believes that the inhaler-style of the drug/device should support patient compliance, offering fast delivery and action. Preclinical research for OCT130401 was completed during FY23, and the company plans to conduct a Phase I trial in Australia, subject to additional funding, and hence this Phase I-ready programme is currently on hold.
Programmes 3 and 4: the company’s third and fourth assets come from OCT’s library of cannabinoid derivatives, comprised of proprietary and in-licensed compounds (475 synthetic derivatives of cannabinoids (CBD, THC)). These have been chemically optimised to improve properties such as bioavailability, and the company is in the process of filing for patent protection for these assets. While management has not yet disclosed the neuropathic pain indication for OCT960609 (programme 3), it has confirmed the asset is a dual CB1/CB2 agonist, and early studies suggest it may have a better profile than THC in terms of analgesia and behavioural alterations. For programme 4, OCT announced in July 2023 that this asset, an immunotherapy agent, will target solid tumours, diversifying the company’s pipeline beyond pain indications. We note that programmes 3 and 4 will also be put on hold once they reach preclinical and lead stages, respectively, so that OCT can focus on the clinical development of programme 1.
Financials
In FY23, the company reported an operating loss of £7.0m, a 27.8% y-o-y increase compared to £5.5m in FY22, noting the lower operating loss of £2.5m in H223 as compared to £4.5m in H123. The higher operating loss in FY23 was primarily led by higher research costs at £4.3m (vs £2.9m in FY22), mainly related to preclinical activities for OCT461201 (£2.0m) and OCT130401 (£1.9m), along with minor allocations to other development programmes. Administrative expenses were up 15.1% y-o-y to £2.7m, which included £1.4m in salaries. Reflecting the higher operating expenses, OCT recorded operating cash outflows of £6.9m in FY23 as compared to £5.4m in FY22.
We note that OCT ended FY23 with a net cash balance of £2.3m, which management expects to provide a cash runway into April 2024. This implies that OCT will likely cut down its research and administrative expenses during the year to create some operational headroom before an anticipated capital raise in H224. As a reminder, we assume a £15m capital raise in FY24, which we have modelled as illustrative debt. In line with management guidance, we have reduced our FY23 estimates for research costs to £1.0m (£8.5m previously), assuming all development activities (except the Phase I trial of OCT461201) remain on hold until the imminent capital raise. We expect OCT to move ahead with the Phase II trial for OCT461201 and other clinical/preclinical activities only after an expected capital raise in H224. As a reminder, our trial timelines forecast product launch in FY30, which differs from OCT’s communicated timeline of FY27, as we have been more conservative in our assumptions. To reflect the current cash crunch, we have also reduced our FY24 estimates for administrative expenses to £1.9m (£2.8m previously).
After incorporating the above-mentioned changes (along with minor changes based on the FY23 results), our operating cash burn for FY24 stands at £2.9m, which we believe will be H224-loaded and should provide a cash runway into Q424, in line with management guidance. We have also introduced FY25 estimates, with an expected operating loss of £9.9m, including £7.5m in research costs. We project that the company will resume its development activities in FY25, after raising capital in H224.
Valuation
To incorporate the cash constraints and current halt in development activities, we have pushed out our launch timelines for OCT461201 in both IBS and CIPN indications to FY30 (vs FY29 previously). We note our trial timeline forecasts for product launch differ from OCT’s communicated timeline of FY27, as we have been more conservative in our assumptions. We now expect the Phase II trial to conclude in FY26 (FY25 previously), prior to which we expect OCT to take on all R&D expenses. Reflecting these changes, we now project the company to secure a licensing deal in FY27 as compared to FY26 previously. More details on assumed licensing deals are covered in our initiation note.
Our valuation for OCT adjusts to £25.3m or 2.6p per share (£26.1m or 2.7p/share previously), mainly due to the pushed out launch timelines, along with the combined impact from rolling forward the model, estimate changes and an updated net cash balance. As a reminder, our valuation is primarily based on an rNPV of the company’s lead asset, OCT461201.
We continue to estimate the need for a £40m fund raise across FY24–26, which is shown as illustrative debt in our model. If these funds are raised through an equity issue, OCT would need to issue an additional 4,545m shares (at the current share price of 0.88p), which would dilute our per share valuation to 1.2p per share, from 2.6p per share currently.
Exhibit 2: OCT NPV valuation
Product |
Indication |
Clinical stage |
Launch |
Peak sales ($m) |
Value |
Probability |
rNPV |
rNPV/share (p) |
|
OCT461201 |
IBS |
Phase 1 |
FY30 |
1,612 |
20.2 |
10% |
15.9 |
1.66 |
|
CIPN |
Phase 1 |
FY30 |
932 |
9.0 |
10% |
7.1 |
0.74 |
||
Net cash at end FY23 |
|
|
|
|
2.9 |
100% |
2.3 |
0.24 |
|
Valuation |
|
|
|
|
32.2 |
|
25.3 |
2.64 |
|
Source: Edison Investment Research. Note: WACC = 12.5%.
Exhibit 3: Financial summary
£000s |
2022 |
2023 |
2024e |
2025e |
||
Year-end April |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
0 |
0 |
0 |
0 |
Cost of Sales (Research costs) |
(2,891) |
(4,304) |
(1,000) |
(7,500) |
||
Gross Profit |
|
|
(2,891) |
(4,304) |
(1,000) |
(7,500) |
Administrative expenses |
(2,320) |
(2,670) |
(1,869) |
(2,430) |
||
Exceptional items |
(292) |
(64) |
0 |
0 |
||
EBITDA |
|
|
(5,054) |
(6,935) |
(2,862) |
(9,930) |
Depreciation |
(23) |
0 |
0 |
0 |
||
Amortisation |
(36) |
(39) |
(7) |
0 |
||
Operating profit (before amort. and excepts.) |
|
|
(5,113) |
(6,974) |
(2,869) |
(9,930) |
Share-based payments |
(292) |
(64) |
0 |
0 |
||
Exceptionals |
0 |
0 |
0 |
0 |
||
Operating Profit |
(5,503) |
(7,038) |
(2,869) |
(9,930) |
||
Net Interest |
0 |
4 |
9 |
59 |
||
Profit Before Tax (norm) |
|
|
(5,113) |
(6,970) |
(2,860) |
(9,871) |
Profit Before Tax (reported) |
|
|
(5,503) |
(7,034) |
(2,860) |
(9,871) |
Tax |
791 |
1,089 |
443 |
1,528 |
||
Profit After Tax (norm) |
(4,322) |
(5,881) |
(2,417) |
(8,343) |
||
Profit After Tax (reported) |
(4,712) |
(5,945) |
(2,417) |
(8,343) |
||
Average Number of Shares Outstanding (m) |
960.4 |
960.4 |
960.4 |
960.4 |
||
EPS - normalised fully diluted (p) |
|
|
(0.49) |
(0.61) |
(0.25) |
(0.87) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
46 |
7 |
0 |
0 |
Intangible Assets |
46 |
7 |
0 |
0 |
||
Tangible Assets |
0 |
0 |
0 |
0 |
||
Other assets |
0 |
0 |
0 |
0 |
||
Current Assets |
|
|
11,772 |
4,488 |
17,108 |
23,796 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
2,607 |
2,191 |
2,301 |
2,416 |
||
Cash |
9,166 |
2,297 |
14,807 |
21,380 |
||
Other |
0 |
0 |
0 |
0 |
||
Current Liabilities |
|
|
(2,025) |
(584) |
(613) |
(644) |
Creditors |
(2,025) |
(584) |
(613) |
(644) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
||
Other current liabilities |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
0 |
0 |
(15,000) |
(30,000) |
Long term borrowings |
0 |
0 |
(15,000) |
(30,000) |
||
Other long term liabilities |
0 |
0 |
0 |
0 |
||
Net Assets |
|
|
9,793 |
3,912 |
1,495 |
(6,848) |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(5,373) |
(6,868) |
(2,490) |
(8,427) |
Net Interest |
0 |
4 |
0 |
0 |
||
Tax |
0 |
170 |
443 |
1,528 |
||
Capex |
3 |
0 |
0 |
0 |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
||
Financing |
0 |
0 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
(5,371) |
(6,694) |
(2,048) |
(6,899) |
||
Opening net cash/(debt) |
|
|
14,581 |
9,166 |
2,297 |
(193) |
Other |
0 |
0 |
0 |
0 |
||
Closing net cash/(debt) |
|
|
9,166 |
2,297 |
(193) |
(8,620) |
Source: Company reports, Edison Investment Research
|
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Research: Healthcare
Mendus has announced that the FDA has granted Fast Track designation to its lead cancer vaccine, vididencel, as a potential maintenance therapy in acute myeloid leukaemia (AML). This regulatory decision was based on interim results from the ADVANCE II trial (reported in December 2022), which showed encouraging survival data to support vididencel as a monotherapy in AML maintenance, as well as a desirable safety profile. Benefits of Fast Track designation include more frequent interactions with the FDA for an expedited approval process and a ‘rolling review’ for its market application. We believe that Fast Track designation represents a key milestone, enabling a potentially accelerated route to market, provided clinical results continue to be positive. Updated data (relapse free survival and overall survival) from the ADVANCE II trial are expected in Q424. Mendus is also preparing for an additional Phase II combination trial with Onureg, which is on track to commence by end-2023.