Thanks.

Kazia Therapeutics’ paxalisib program data garners increased target share price of A$2.83 from Edison

Edison has increased its valuation to A$375 million or A$2.83 per basic share from A$346 million or A$2.68 per basic share mainly due to rolling forward its Net Present Value (NPV).

Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) has received an increased target price share from Edison Group, rising to A$2.83 from A$2.68 a share following the release of interim data for its 30-patient Phase II trial of paxalisib in newly diagnosed glioblastoma multiforme (GBM) patients.

Final data from the trial as well as initial data for paxalisib in the treatment of brain metastases (BMs) is expected before the end of this year. Additionally, the Phase I trial for EVT801 – a treatment targeting solid tumours – is expected to begin enrolment by year-end.

Glioblastoma is the most common and aggressive brain tumour and accounts for approximately half of all gliomas. According to the US National Cancer Institute, there are approximately 23,820 cases per year of brain and other nervous system cancers in the US and another 64,600 in Europe, according to the International Agency for Research on Cancer.

The survival rate of GBM is especially poor with a five-year survival rate of only 5.1% and a median overall survival (OS) of just 10 months.

Kazia released interim data from 29 patients from its trial in newly diagnosed GBM patients. The data showed progression-free survival (PFS) of 8.4 months and OS of 17.5 months.

These results are an improvement over the historical PFS and OS data from temozolomide, a mainstay of GBM treatment.

The following excerpts are from Edison Group’s research report.

Initial data incoming for BM

The Edison Group considers BMs one of the most interesting indications for which paxalisib could potentially be used and the drug is being investigated for this indication in three clinical studies: one Phase I and two Phase IIs, sponsored by Sloan-Kettering, Alliance Group and Dana-Farber respectively.

Some initial data from these studies are expected in Q4 CY21.

EVT801 Phase I program

EVT801 is an oral small molecule that targets vascular endothelial growth factor receptor 3 (VEGFR3), which Kazia licensed from Evotec in April.

Kazia expects to initiate the Phase I program by the end of the year. Phase I will enrol up to 90 patients with advanced solid tumours that are resistant to existing therapies.

Valuation: A$2.83 per basic share

Edison has increased its valuation to A$375 million or A$2.83 per basic share from A$346 million or A$2.68 per basic share mainly due to rolling forward its Net Present Value (NPV). This was partially offset by lower net cash and slightly higher expenses.

Kazia reported net cash of A$27.6 million at June 30, 2021. Edison’s estimated financing requirement for the company is A$60 million (including A$30 million in FY23), up from A$50 million previously due to increases in R&D spending.

Paxaslib

Paxalisib is a PI3K and mTOR inhibitor being studied in several clinical trials involving cancer in the brain. The drug is in a 30-patient Phase II study of patients with newly diagnosed GBM and unmethylated MGMT promotor, with final data expected in Q4 CY21. Paxalisib is being used as an adjuvant following initial resection, radiation treatment and temozolomide.

Therapeutic options are limited. Since 2005, only three new treatments have been approved for GBM: temozolomide, bevacizumab and tumour-treating fields. The standard of care for newly diagnosed GBM is a combination of surgery, radiation and temozolomide with recurrence occurring due to resistance to temozolomide.