Currency in AUD
Last close As at 03/02/2023
AUD6.75
▲ −0.77 (−10.24%)
Market capitalisation
AUD17m
Research: Healthcare
Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA approval as an encouraging development as it allows Medlab to generate additional real-world data to support the anticipated Phase III clinical trial of synthetic NanaBis in FY23. Positive feedback from compassionate use may create patient advocates and key opinion leaders for the drug. In our view, this new approval provides further regulatory validation for Medlab’s NanaBis/NanaDol product and the NanoCelle platform in general. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.
Medlab Clinical |
UK compassionate use for alternative to opioids |
Regulatory update |
Pharma and biotech |
29 November 2022 |
Share price performance Business description
Analysts
Medlab Clinical is a research client of Edison Investment Research Limited |
Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA approval as an encouraging development as it allows Medlab to generate additional real-world data to support the anticipated Phase III clinical trial of synthetic NanaBis in FY23. Positive feedback from compassionate use may create patient advocates and key opinion leaders for the drug. In our view, this new approval provides further regulatory validation for Medlab’s NanaBis/NanaDol product and the NanoCelle platform in general. We maintain our valuation of Medlab at A$236.1m or A$103.5/share.
Year end |
Revenue (A$m) |
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.
As a reminder, synthetic NanaBis, a 50:50 formulation of synthetic CBD and dronabinol (synthetic THC), is awaiting approval for the initiation of Phase III studies, which we view as the next significant catalyst for the share price performance. The company has prepared a Drug Master File and we expect Medlab to approach the FDA with an Investigational New Drug application in Q4 CY22/Q1 CY23. Importantly, for US approval, the trial will enrol patients at sites in the United States, UK and Australia. The company is also developing NanoCBD, a 100% CBD formulation to treat occupational stress and mental health issues.
The NanaDol approval follows the similar UK approval for NanoCBD in April 2022 and it will be supplied through the established distribution partner, WEP Clinical. Following the approval, the company is awaiting the certification required to ship NanaDol from Australia, which will allow NanaDol to be prescribed under compassionate use by clinicians in the UK. While the data collected will not be as controlled as a Phase III clinical trial, we see this as a cost-effective method to get clinically relevant data to support future drug applications. Management expects the medicine is likely to be available for UK patients in January 2023.
NanaDol will be made available to patients in the UK through doctor prescriptions only for pain (including cancer-related bone pain), an area that the medicine is targeting. Under the current arrangement, Medlab will be charging a ‘compassionate’ price (usually a discount to the expected list price), so we expect any additional revenue generated from compassionate use to be marginal.
|
|
Research: Healthcare
The Respiri/Access Telehealth collaboration continues to make steady gains in the US with the partners announcing their fourth commercial deal to date, with Arkansas Heart Hospital (AHH), a healthcare facility focussed on cardiovascular health. The program will focus on assessing the utility of Respiri’s wheezo device in a remote patient monitoring (RPM) setting using Access Telehealth’s cloud-based RPM solution, Remotli. The target population will include cardiovascular patients also suffering from chronic obstructive pulmonary disease (COPD), a common comorbidity. The deal follows close on the heels of the recent agreement signed with Minnesota Lung Center, although we note that, unlike the former, the AHH deal forgoes the requirement for an initial pilot study. Patient recruitment is expected to commence with immediate effect. As with the previous deals, we expect the monitoring services to be eligible for reimbursement under the Centers for Medicare and Medicaid Services’s (CMS’s) Current Procedural Terminology reimbursement codes for RPM. The market has reacted positively to the news, with the stock closing 18% higher.
Get access to the very latest content matched to your personal investment style.