As Medlab Clinical moves into 2023, the expected commencement of a Phase III trial for NanaBis (the company’s cannabinoid based analgesic therapy) in cancer-induced bone pain will be the focus for investors. Management made considerable progress towards Phase III in 2022, by switching to a purely synthetic cannabinoid formulation and gathering encouraging real-world data on NanaBis use. We believe these actions should maximise the potential for NanaBis in both a regulatory and a commercial setti...
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 redu...
MEDLAB ANNOUNCES FAVOURABLE INTERIM READOUT OF NANABIS™ REAL-WORLD EVIDENCE (RWE) MEDCARE STUDY N=1,172 Australian pain patientsDatapoints collected from commencing NanaBis™ (baseline) up to month 1255% improvement in pain relief75% of patients reduced their opioid use31% Improvements in Quality of Life as it relates to pain interference92% of patients with bone metastasis from cancer had reduced their pain severity and pain interference (Quality of Life) scores at 6-monthsNew “ENHANCE” study expects to onboard March 2023 Sydney, Jan. 12, 2023 (GLOBE NEWSWIRE) -- Medlab Clinical Ltd ...
Medlab Clinical has announced that it has cleared the Securities Exchange Commission’s (SEC’s) comments on its Nasdaq listing and is now preparing to finalise its application with its US broker, Alliance Global Partners. After this announcement, we expect Medlab will remain on track to meet its listing target timeline of Q1 CY23, which coincides with the anticipated investigational new drug (IND) submission for NanaBis in the US (to start Phase III trials). Due to the high activity and liquidity...
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 appro...
Medlab Clinical has released its unaudited cash flow report for Q123 and provided an update for the period. The company’s cash position was bolstered by the receipt of A$0.3m from sales of NanaBis and NanoCBD (under the Doctors Special Access Scheme) as well as a A$3.6m government R&D grant. In the absence of the grant, the company’s net cash outflow from operating activities for the quarter was A$3.5m. At the current burn rate and with a net cash position of A$5.3m (A$5.2m at end-FY22), we esti...
Medlab Clinical has announced it has received ethics approval to conduct two new observational clinical trials in Australia for its lead developmental programmes, NanaBis and NanoCBD. The studies aim to investigate the long-term efficacy, tolerability and safety profiles of the products in the target populations. In our view these studies are an important milestone in the clinical progression of NanaBis and NanoCBD as, assuming positive readouts, the results will help generate data packages to s...
As part of its transformation into a pureplay biotech, Medlab is preparing an IND submission for NanaBis and plans to begin clinical trials with both NanaBis and NanoCBD in the next 12 months. In FY22, Medlab’s total revenue from continued operations increased 35.3% y-o-y, however, total group revenue was up 5.3%% y-o-y, due to the licensing of the nutraceutical business in October 2021. The net cash outflow from operating activities in FY22 was A$9.3m, in line with our estimates. We see a poten...
Medlab Clinical has released its cash flow report for Q422 and the full FY22 period. Net cash outflow from operating activities in FY22 was A$9.0m, roughly in line with our estimate of A$9.3m. The company reported cash operating revenues for the year of A$6.2m, however it expects to record a A$3.5m research and development grant post the period end (in September/October 2022). Total cash outflow for FY22 was A$8.2m, which was lower than our estimate of A$9.3m as the company received A$750k and w...
Following the company’s transformation to a pureplay biotech, Medlab Clinical has focused on the development of key asset NanaBis, a 50:50 micellar formulation of CBD and THC, in the treatment of cancer-induced bone pain. Based on recommendations from the FDA, Medlab has switched to using synthetic active pharmaceutical ingredients (APIs) in NanaBis and is imminently expected to approach the regulators for approval of a Phase III trial. We expect a recently compiled drug master file (DMF) for Na...
In its former shape, Medlab used the cash flows from selling innovative nutraceuticals to fund pharmaceutical research. With lead product NanaBis (NanoCelle encapsulated 50:50 THC:CBD for pain) preparing to enter a Phase III trial in pain, management has decided to fully focus on therapeutics development and divested its nutraceuticals portfolio in November 2021. As a pure-play biotech, Medlab is also focused on optimising its R&D portfolio, which has many initiatives. Historically, Medlab has e...
In its former shape, Medlab used the cash flows from selling innovative nutraceuticals to fund pharmaceutical research. With lead product NanaBis (NanoCelle encapsulated 50:50 THC:CBD for pain) preparing to enter a Phase III trial in pain, management has decided to fully focus on therapeutics development and divested its nutraceuticals portfolio in November 2021. As a pure-play biotech, Medlab is also focused on optimising its R&D portfolio, which has many initiatives. Historically, Medlab has e...
Medlab (ASX:MDC) receives Government grant to apply NanoCelle® to an RNA nasal vaccine in collaboration with University of NSW (UNSW) and Macquarie University (MQ) to fight COVID-19 future potential epidemics NSW Government grant received on 23rd December 2021 to develop a “no-jab” vaccine solutionMedlab collaborates with UNSW and MQ University (two leading global academic and R&D institutions)This NanoCelle® non-invasive nasal delivered vaccine is considered a “first in class” medicine delivery systemThis Government Grant & Academic collaboration solidify Medlab’s transition to a true Biot...
Nanocelle® Patent Granted in Usa Medlab receives Granted Patent Protection for NanoCelle® in the USA by US Patent & Trademark Office (USPTO) SYDNEY, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Medlab Clinical Ltd (ASX: MDC) is extremely pleased to announce the USPTO has granted patent protection for NanoCelle® “Transmucosal and transdermal delivery systems” (Patent No. 11160753) in the United States of America. This announcement follows just three weeks after announcing the ‘Notice of Allowance’ received by the USPTO. (October 06, 2021). Medlab has now filed and granted global Patent protecti...
DEPRESSION PATENT FOR OROTATE APPROVED & GRANTED BY US PATENT OFFICE SYDNEY, Oct. 11, 2021 (GLOBE NEWSWIRE) -- Medlab Clinical LTD (ASX:MDC) is pleased to announce the Orotate patent, specifically to addressing depression in United States of America has been granted. The United States Patent and Trademark Office (USPTO) has applied a Patent term to 28 MAY 2037 with a US patent number 11,135,181. Previously Medlab announced [5 Jul 2021] final trial readouts for its phase 2 Depression trials.Orotate use as a drug substance was key to the investigative product “NRGBiotic™”. The company has...
NANOCELLE “ISSUE OF ALLOWANCE” BY US PATENT OFFICE SYDNEY, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Medlab Clinical LTD (ASX.MDC) is pleased to announce NanoCelle® the company’s proprietary delivery platform has been issued a “Notice of Allowance” by the USPTO (United States Patent and Trademark Office). Pursuant to the Notice of Allowance, fees associated with the patent have been paid and MDC is expecting to receive GRANT Status with US patent numbers and expiry dates within the next 4 weeks. Dr Sean Hall, CEO of MDC said “after approximately 4 years, this is an exceptional o...
Full Article at IIR has reaffirmed its Recommended rating for PIA after undertaking a review post the appointment of a new Portfolio Manager, Harding Loevner. The full report can be found on the IIR website. On 26 July 2021, Pengana International Equities Limited (PIA) announced a fully franked dividend of 1.35 cents per share for the June quarter. This represents an 8% increase on the March quarter dividend and takes the total dividends declared for FY21 of 5.1 cents per share, fully franked....
US Patent Office issues Notice of Allowance status for NRGBiotic™ for treating, preventing, or Ameliorating depression or a Depressive disorder. SYDNEY, July 27, 2021 (GLOBE NEWSWIRE) -- Medlab Clinical Ltd (ASX.MDC), an Australian biotech using delivery platforms to enhance medicines is very pleased to announce the United States Patent Office (USPTO) has issued a Notice of Allowance for Application number 15/523,271 for the formulation known as NRGBiotic™, currently available in Australian Pharmacies. The Notice of Allowance refers to a USPTO designation that the Patent is allow...
Edison Investment Research Limited Edison Investment Research Limited: Medlab Clinical (MDC): Initiation - Novel drug delivery and cannabinoids against pain 12-Jul-2021 / 21:00 GMT/BST London, UK, 13 July 2021 Medlab Clinical (MDC): Initiation - Novel drug delivery and cannabinoids against pain Medlab's proprietary platform, NanoCelle, is a patented nanomicellar formulation that can improve the delivery of drugs. Medlab's lead product is NanaBis, a combination of THC and CBD (1:1) cannabinoids encapsulated in NanoCelle particles, which enable a convenient buccal spray formu...
Medlab is a drug delivery biotechnology company with a proprietary platform, NanoCelle, which is a patented nanomicellar formulation that can improve the delivery of drugs. With the growing appreciation of the medicinal properties of cannabis, Medlab’s lead product became NanaBis, a THC:CBD (1:1) cannabis extract encapsulated in NanoCelle particles, which enable a convenient buccal spray delivery. The most recent breakthrough was Medlab’s announcement that it had successfully produced a syntheti...
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