Kazia Therapeutics says it had $15.2 million in cash at the end of December 2021 having committed $11.4 million during the period to progress its pipeline.
The company said it is funded through to the fourth quarter of this calendar year.
“The second half of calendar 2021 followed a remarkable period earlier in the year, during which the company advanced its lead program, paxalisib, into an international pivotal study, and executed three substantial cross-border partnering transactions,” said chair Iain Ross.
“As such, it is appropriate that the last six months has been, by contrast, a period characterised by diligent consolidation, operational execution, and consistent delivery of our plans.
“At the forefront of these is the task of achieving readiness for a potential regulatory filing in respect of paxalisib.”
Mr Ross said the GBM AGILE pivotal study of paxalisib in glioblastoma is well-advanced. It commenced recruitment to the paxalisib arm in January 2021.
“We expect data in calendar 2023. If that data reflects our hopes and expectations for the drug, it will lead us directly into a new drug application (NDA) with the United States Food and Drug Administration (FDA), a process that we hope will see paxalisib become the first new drug treatment approved for newly diagnosed glioblastoma patients in over twenty years,” he said.
Mr Ross continued, “For the drug, we must now begin considering it as a potential commercial product.”
“Our company is, in all important respects, not much more than half a decade old, and yet it may find itself in possession of a first-class pharmaceutical product within a short period of time.
“It would be naïve to imagine that the company will not itself be transformed by the remarkable progress of its pipeline. One visible manifestation of this is the augmentation of our management team, with two highly experienced, US-based colleagues joining the company in the fourth quarter of calendar 2021. Dr John Friend, our Chief Medical Officer, and Karen Krumeich, our Chief Financial Officer, will work closely with Dr James Garner, our Chief Executive Officer, and the other members of the Kazia team to ensure that we are ready to make a success of the opportunities ahead of us.”
Mr Ross said the company plans to expand the clinical development of paxalisib to include a range of brain cancers and potentially diseases outside the central nervous system.
He also said it has started clinical development of EVT801 that it licensed from Evotec SE in April 2021.
“The speed with which we have been able to move the drug forward reflects our excitement about its potential, the enthusiasm of the clinicians with which we are working, and the extraordinary efforts of the Evotec team, who remain our close allies in the development of this very promising drug,” he said.
