Kazia Therapeutics

DR JAMES GARNER

CEO & MANAGING DIRECTOR

(ASX:KZA)

◾ Company Name: Kazia Therapeutics ◾ Company ASX code: KZA ◾ Key areas: Biotech - oncology ◾ Key Personnel: Dr James Garner, CEO & Managing Director | Dr John Friend, Chief Medical Officer | Karen Krumeich, Chief Financial Officer ◾ Locations: New South Wales, Australia ◾ Market Cap as of 15/09/22: $35.16M ◾ 52 Week share price as of 15 September: $0.195 - $1.650 ◾ Company Website: kaziatherapeutics.com

COMPANY PROFILE

Kazia is a late-stage oncology company, with two potential cancer drugs in human trials.

Their lead program is paxalisib, a brain-penetrant inhibitor of the PI3K/ Akt/mTOR pathway, which is being developed to treat several forms of brain cancer, including glioblastoma and the rare and aggressive childhood brain cancer, diffuse intrinsic pontine glioma (DIPG).

Despite all efforts, the prognosis for patients with brain cancer has improved little in the past two decades.

For glioblastoma, the most common and most aggressive form of brain cancer, average life expectancy from diagnosis is around 15 months, and less than 5% of patients are still alive after five years.

Not only is it a huge unmet clinical need – glioblastoma affects approximately 130,000 patients per annum worldwide – it is conservatively estimated to represent a US$1.5 billion annual commercial market.

If paxalisib can also be approved for other forms of brain cancer, that is expected to create additional opportunities for the product.

Kazia is casting a wide net in its clinical trials to explore the potential for the drug in a range of treatment areas – unlike the majority of biotech players who tend to put all their eggs in one basket.

The company currently has eight clinical trials underway, including GBM AGILE, a pivotal study in glioblastoma, which is due for completion in another 12 months’ time.

The company also recently announced positive interim results from a phase I clinical trial of paxalisib in combination with radiotherapy for the treatment of brain metastases – namely a 100% overall response rate which means every evaluable patient has had some meaningful response.

That particular trial could lead to a potentially huge opportunity for Kazia and treat an enormous unmet need, with around 200,000 patients diagnosed with brain metastases each year in the United States alone. The next step is for the study to recruit another 12 patients, with final data expected in 2023.

A clinical trial of the combination of paxalisib with ONC201 (Chimerix, Inc) in the treatment of DIPG and diffuse midline gliomas (DMGs) commenced recruitment in November 2021 under the sponsorship of the Pacific Pediatric Neuro-Oncology Consortium (PNOC), with initial data anticipated in in the first half of 2023.

It remains very clear the company has plenty of opportunities in the pipeline for paxalisib. The drug was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020.

It was also granted Rare Paediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for AT/RT – another childhood brain cancer - in June 2022.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno- oncology agents.

A phase I study for EVT801 commenced recruitment in November 2021, with interim data expected in 2H CY2022 or 1H CY2023.

The company launched a new Scientific Advisory Board (SAB) in July 2022, comprising four leading experts in brain cancer which it says reflects the late stage of development of paxalisib in brain cancer and has been designed to support imminent initiation of precommercial activities for the drug.

KEY INVESTMENT HIGHLIGHTS

JUNE 12, 2022: Compelling preclinical data supporting the efficacy of paxalisib with ONC201 in the treatment of DIPG leads to new clinical trial. JULY 6, 2022: Paxalisib awarded Rare Pediatric Disease Designation (RPDD) by US FDA for treating rare, aggressive childhood brain cancer, atypical rhabdoid/teratoid tumors. AUGUST 8, 2022: Phase I clinical trial of paxalisib in combination with radiotherapy shows a complete/partial response rate of 100%.