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Today, on 2nd May 2019, the biotechnology company AdAlta Limited (ASX:1AD) announced that it is well on track with the development of AD-214 (a lead program) for Idiopathic Pulmonary Fibrosis, following the successful completion of a confirmation run for manufacturing of AD-214. The confirmation run has seen for the first time AD-214 cell-line expression at a 50 L scale (upstream) and purification (downstream) combined into a single manufacturing process. This confirmation run has enabled AdAlta to demonstrate that the process for the production of AD-214 materials has been developed and AD-214 can be made at a larger scale.
The companyâs Chief Operating Officer, Dallas Hartman, stated that they are pleased with the development of the manufacturing process for AD-214, and are looking forward to completing the demonstration run over the next few months, which will deliver the materials for the companyâs four-week non-human primate toxicology study.
It is anticipated that AD-214 materials will be available at the end of June, following which the company will commence its four-week non-human primate Good Laboratory Practice (GLP) toxicology study in July 2019, which is expected to be completed later this year. AdAlta also remains on track to deliver Good Manufacturing Practice (GMP) material for its Phase 1 human study, which is expected to commence in January 2020. The completion of the confirmation run follows the announcement in January 2019, of improved cell line expression results for AD-214 of 3 grams per litre (3g/L), up from the 1g/L reported in October 2018.
The groupâs Chief Executive Officer, Sam Cobb, confirmed that the processes can be pulled together and AD-214 can be made on a larger scale, which is crucial as they continue to progress their lead candidate AD-214 towards the clinic. They expect to complete the four-week non-human primate toxicology study for AD-214 in the second half of 2019, which will then lead the company into the clinic in early 2020.
In a previous update, AdAlta announced quarterly cash flow statement, where manufacturing development results were ahead of expectations, with the cell-line yield at 3 grams per litre (3g/L). The group entered into a collaborative partnership with UK-based research organisation, Excellerate Bioscience, to advance the development of its i-body pipeline, involving identification of a unique efficacy, safety and duration. This will help verify which are the best-in-class ones for binding to drug targets, specifically G protein-coupled receptors (GPCRs).
The company reported a cash position of $3.05 million as on 31st March 2019 and expects an R&D tax refund of around $3 million in the September 2019 quarter based on the 2019 R&D expenditure.
At the time of writing (on 2nd May 2019, AEST 1:30 PM), the stock of AdAlta Limited was trading at $0.180, down 2.703% with a market capitalisation of ~$21.76 million. Today, it touched dayâs high at $0.185 and dayâs low at $0.180, with a daily volume of 10,661. Its 52 weeks high price stands at $0.400 and 52 weeks low price at $0.165, with an average volume of 34,894. Its absolute returns for the past one year, six months and three months are -36.21%, -30.19%, and -31.48%, respectively.
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