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Currency in AUD
Last close As at 27/03/2023
AUD6.60
▲ −0.29 (−4.21%)
Market capitalisation
AUD15m
Research: Healthcare
Medlab Clinical has announced positive interim data from its real-world evidence study for NanaBis (Medcare observational study). The 12-month study comprised 1,172 patients (with both cancer and non-cancer related pain) and exhibited a good safety, tolerability and sustainability profile for NanaBis use. The enrolled patients reported a 55% improvement in pain relief, along with reduced opioid use in 75% of the patients. Importantly, 92% of the patients with cancer bone metastasis reported reduced pain severity and pain interference scores after six months. Final data are expected in July 2023 and Medlab plans to relaunch the study as the ENHANCE study in March 2023, with the objective to generate more focused data. We expect data from this study to support Medlab’s efforts in securing regulatory approval to initiate Phase III trials for NanaBis.
Medlab Clinical |
Encouraging real-world data to support NanaBis |
Medcare study update |
Pharma and biotech |
17 January 2023 |
Share price performance
Business description
Analysts
Medlab Clinical is a research client of Edison Investment Research Limited |
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Medlab Clinical has announced positive interim data from its real-world evidence study for NanaBis (Medcare observational study). The 12-month study comprised 1,172 patients (with both cancer and non-cancer related pain) and exhibited a good safety, tolerability and sustainability profile for NanaBis use. The enrolled patients reported a 55% improvement in pain relief, along with reduced opioid use in 75% of the patients. Importantly, 92% of the patients with cancer bone metastasis reported reduced pain severity and pain interference scores after six months. Final data are expected in July 2023 and Medlab plans to relaunch the study as the ENHANCE study in March 2023, with the objective to generate more focused data. We expect data from this study to support Medlab’s efforts in securing regulatory approval to initiate Phase III trials for NanaBis.
Year end |
Revenue |
PBT* (A$m) |
EPS* |
DPS |
P/E |
Yield |
06/21 |
8.1 |
(12.4) |
(6.3) |
0.0 |
N/A |
N/A |
06/22 |
6.0 |
(8.4) |
(3.1) |
0.0 |
N/A |
N/A |
06/23e |
7.7 |
(8.8) |
(3.8) |
0.0 |
N/A |
N/A |
06/24e |
7.7 |
(9.6) |
(4.2) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Medlab’s lead asset, NanaBis, is a 50:50 formulation of synthetic CBD and dronabinol (synthetic THC) being developed to treat cancer-induced bone pain. Medlab is awaiting approval to initiate Phase III studies for NanaBis, with plans to commence patient enrolment in Q4 CY23. The Phase III study will be a multi-centre (Australia, United States and United Kingdom), double-blinded, placebo-controlled study and is expected to enrol 360 patients. Medlab has prepared a drug master file and we expect the company to approach the FDA with an investigational new drug application in Q1 CY23.
Under the Medcare observational study, patients received NanaBis for an average period of 5.4 months with a median dose of six sprays a day. The enrolled patients reported a 55% improvement in pain relief, along with a 23% reduction in pain severity (p<0.0001) following six months of NanaBis treatment. Patients who completed the 12-month treatment observed average pain reduction of 27%. Results from the cancer pain cohort were even better, with a 49% reduction in average pain severity at 12 months. Of the patients previously treated with opioids, 75% reported reduced opioid usage and 60% reported a more than 50% decrease in opioid usage. Notably, 92% of patients with cancer bone metastasis reported improvement in pain severity and interference after six months of treatment. Overall, 454 patients withdrew from the programme, while at least 77 patients have continued to receive NanaBis treatment post study completion.
Real-world data from the Medcare study show efficacy of NanaBis in delivering pain reduction relief, particularly in patients with cancer-related bone pain. We expect this data to support Medlab in securing regulatory approval to conduct Phase III trials and may also help in optimising the trial design.
As a reminder, Medlab is planning a secondary listing on the Nasdaq in Q123 to raise US$7m in net proceeds to support the development of its product pipeline, including NanaBis and NanoCBD.
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Research: TMT
Boku expects to report FY22 revenue and EBITDA slightly ahead of our forecasts and closes the year with stronger than expected net cash. Total payment volume (TPV) was 20% higher y-o-y in constant currency and year-end monthly active users (MAUs) grew 28% y-o-y, helped by the growing contribution from local payment methods (LPMs). We revise our forecasts to reflect stronger revenue growth, with more limited upgrades to EBITDA as we expect gross profit upside to be invested in further expanding and supporting the company’s network of LPMs.
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