Kazia Therapeutics says 20-F is late as audit procedures are not complete

The late filing

Kazia Therapeutics Limited (Nasdaq: KZIA) said on October 31, 2025 that it cannot file its annual report on Form 20-F for the fiscal year ended June 30, 2025 by October 31, 2025, the prescribed due date. It filed a Form 12b-25 notice of late filing, which gives a company a short grace period when a report cannot be filed on time without unreasonable effort or expense.

The notice says more time is needed to finalize the consolidated financial statements for the year. As a result, the company's independent registered public accounting firm needs more time to complete its audit procedures on those statements. The company anticipates it will file the annual report no later than the fifteenth calendar day following the prescribed filing date. The notice gives no other cause for the delay.

Kazia answered no when asked whether it expects a significant change in results of operations from the corresponding period of the last fiscal year. The notice gives no cash, revenue or loss figures for the year. The notice is signed by Chief Executive Officer John Friend.

The company and its lead drug

Kazia Therapeutics Limited is a company limited by shares, incorporated in March 1994 and registered in New South Wales, Australia, with its registered office in Sydney. Its American depositary shares, each representing one-hundred ordinary shares, trade on the Nasdaq Capital Market under the symbol KZIA. Its 2024 annual report describes the company as an emerging oncology-focused biotechnology company.

Its lead program is paxalisib, formerly GDC-0084, an investigational, brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway. Genentech developed the compound, and Kazia took a worldwide exclusive license in October 2016. The company says paxalisib is the only PI3K inhibitor in mainstream clinical development known to cross the blood-brain barrier. It also says the drug works by a different mechanism from temozolomide, the FDA-approved standard of care, which works primarily by alkylating guanine residues in DNA.

Those are the company's own claims about its position. The same filing notes that five PI3K inhibitors have been approved by the FDA for a range of hematological malignancies and solid tumors. The filing calls the target well validated in cancer, and its argument for paxalisib is the blood-brain barrier claim, not the target itself.

The trial record and its limits

The clinical record rests on a phase I trial that Genentech completed in 47 patients with advanced recurrent grade III and grade IV glioma. The most common adverse events were oral mucositis and hyperglycemia. Using ANO criteria, 40% of patients had stable disease as their best observable response, and 26% showed a metabolic partial response on FDG-PET.

Those are early figures from a small phase I study of 47 patients. They describe that group and cannot show that the drug works in a larger population.

Regulatory designations have followed. Orphan drug designation for glioblastoma came in February 2018, and for glioma in August 2020. The FDA granted Fast Track designation for glioblastoma and Rare Pediatric Disease designation for diffuse midline gliomas in August 2020. Orphan designation for atypical rhabdoid/teratoid tumours (AT/RT) came in June 2022. On July 6, 2023, Kazia announced Fast Track designation for solid tumor brain metastases with PI3K pathway mutations, in combination with radiation therapy.

Patents and the clinical programs

Paxalisib's composition-of-matter patents are granted or pending in all key territories and, in general, expire in December 2031. The company expects it will be able to secure patent term extensions in the most substantial markets, including the US, EU, China, Japan and Korea, which would provide protection until 2036. A recently granted patent on the manufacturing process would also provide protection until 2036 in relevant territories.

The clinical work is organized in three pillars. The adult brain cancer pillar has four ongoing studies across three patient populations. The pediatric pillar has two actively recruiting studies and one recently completed study. The brain metastases pillar has three ongoing studies. Glioblastoma, which the filing calls a fast-growing and aggressive brain tumour, is the primary focus of the adult work.

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