Kazia Therapeutics Announces Cantrixil Phase 1 Study Part A Results

The Sydney, Australia-based Kazia Therapeutics Limited (ASX: KZA) is an innovative biotechnology company focussed on oncology. Their pipeline includes two clinical-stage drug development candidates including GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway and TRX-E-002-1 (Cantrixil), a third-generation benzopyran molecule with activity against cancer stem cells. Besides, the company is also engaged in developing therapies across a range of oncology indications.

On April 1st, 2019, Kazia Therapeutics released a poster presentation summarising the data from Part A of the ongoing Phase I study of Cantrixil in ovarian cancer, that commenced in December 2016, which will be presented today at the American Association of Cancer Research (AACR) Annual Meeting in Atlanta at 1:00 PM EST.

The study data demonstrate that Cantrixil has a safety profile very suitable for further development thus providing some preliminary evidence of efficacy at this early stage in development with further information to be received upon completion of the ongoing Part B of the study.

Part A of the study was executed in five sites in the United States and Australia and enrolled a total of fourteen patients, of which eleven received at least one dose of Cantrixil. The inference included a Maximum Tolerated Dose (MTD) of 5mg/kg that is within the predicted therapeutic range and around 56 % of the patients (five out of nine) evaluable for efficacy, achieved stable disease after two cycles of Cantrixil monotherapy. Subsequently, one of these five patients achieved a partial response when Cantrixil was administered with chemotherapy. Most of the side effects were gastrointestinal with abdominal pain and fatigue, being the most prominent yet not dose-limiting.

Currently, an expansion cohort, involving enrolment of 12 patients, is underway to get efficacy signals, after the initial data is obtained in the second half of the calendar year 2019.

Recently, the company entered into an arrangement to sell the remainder of its stake in the ordinary shares of Noxopharm Limited via a single block trade. The transaction is expected to generate proceeds of approximately $ 2.1 million, taking the total gross proceeds from their sale to around $ 2.4 million. Meanwhile, Kazia is retaining 3 million unlisted options in Noxopharm, with an exercise price of $ 0.80.

Moreover, on January 15th, 2019 the company received around $ 2,191,257.95 from the Australian Taxation Office under the R&D Tax Incentive Program for the financial year ending June 30th, 2018. All the funds will be utilised in the ongoing R&D programs with multiple data read-outs anticipated shortly.

According to the half-year report for the six months to December 31st, 2018, Kazia Therapeutics reported a massive decline of 1519.1% in the loss for the half-year attributable to the owners to around $ 6.03 million, accompanied by a reduction in the revenue from ordinary activities to $ 28.83k by 56.5% as compared to the prior corresponding period (PCP) ended December 31st, 2017. The company’s net assets were valued at ~ $ 18.37 million including cash and cash equivalents of $ 5.41 million at the end of the period. There were extensive operating activities, undertaken during the half-year, which generated ~ $ 4.36 million of net cash outflows.

The company has a market valuation of over $ 28 million with ~ 62.17 million outstanding shares. With the end of trading on April 1st, 2019, the KZA stock price closed at AUD 0.470, up 2.17% by AUD 0.010. KZA has also generated a positive YTD return of 35.29%.


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