Kazia Therapeutics(US:KZIA)2022-09-01 20:07Financial Performance - Kazia concluded FY2022 with a cash balance of $7.4 million, down from $27.6 million at the end of FY2021[18]. - Total assets decreased to $35 million in FY2022, compared to $58 million in FY2021[18]. - The consolidated entity reported a loss of $24,647,815 for the year ended June 30, 2022, compared to a loss of $8,421,960 for the previous year, indicating a significant increase in losses[108]. - Total revenue for the year ended June 30, 2022, was $15,182,711, compared to $15,182,711 in 2021[178]. - The net loss after income tax for the year was $24,647,815, compared to a loss of $8,421,960 in 2021, indicating a significant increase in losses[178]. - Cash and cash equivalents decreased to $7,361,112 from $27,586,760, representing a decline of approximately 73%[180]. - Total liabilities decreased to $16,320,475 from $20,236,320, a decline of approximately 19%[180]. - Net assets fell to $18,638,287 from $37,850,719, indicating a decrease of about 51%[180]. - The company reported a total comprehensive loss of $24,613,200 for the year, compared to a loss of $8,420,092 in the previous year[178]. - Cash flows from operating activities resulted in a net cash outflow of $22,762,663, significantly higher than the previous year's outflow of $9,110,516[185]. Research and Development - The company invested $22 million in R&D during FY2022, representing over 80% of total expenditures for the year[18]. - Kazia's lead program, paxalisib, has shown encouraging results in its Phase II study for glioblastoma, with significant efficacy data reported[29]. - The Phase II study of paxalisib in glioblastoma has completed recruitment, and the GBM AGILE pivotal study is ongoing, with final data anticipated in 2H CY2023[62]. - Positive signals have been observed in a study of paxalisib combined with radiotherapy for brain metastases, with every evaluable patient showing a radiological response[29]. - Kazia is preparing for a potential regulatory filing for paxalisib, with a pivotal study success rate of over 90% for commercial product approval[64]. - The GBM AGILE pivotal study's paxalisib arm has completed recruitment, with final analysis expected in 2H CY2023[128]. - The company is conducting a Phase II study of paxalisib in combination with trastuzumab for HER2+ breast cancer brain metastases, with initial interim efficacy data expected in 2H CY2022[123]. - The company is also developing EVT801, a selective inhibitor of VEGFR3, which is currently in a phase 1 study that began recruitment in November 2021[108]. Clinical Trials and Drug Development - Paxalisib is involved in eight ongoing clinical trials across four distinct disease areas, with promising outcomes reported in studies of brain metastases[17]. - The first stage of the GBM AGILE pivotal trial for paxalisib has achieved full recruitment, with final data expected in 2H CY2023[15]. - Two new clinical trials for paxalisib have commenced: one at Weill Cornell Medicine and another in collaboration with the Pacific Pediatric Neuro-Oncology Consortium[28]. - The GBM AGILE study has screened over 1,000 patients, exceeding Kazia's expectations for recruitment pace[63]. - The Phase II genomically-guided study of paxalisib in brain metastases has progressed to an expansion stage for breast cancer[124]. - Interim data from a Phase I study of paxalisib in combination with whole brain radiotherapy shows a 100% overall response rate (ORR) among 9 evaluable patients[126]. Strategic Partnerships and Market Opportunities - Kazia has licensed the Greater China region to Simcere Pharmaceutical to expedite paxalisib's entry into China, marking a strategic partnership[69]. - Kazia's focus on brain metastases represents a significant market opportunity, with over 200,000 patients developing brain metastases annually in the U.S.[54]. - The US market typically accounts for 45-50% of the commercial value of a new cancer drug, highlighting the economic importance of this territory[72]. - Kazia's strategy includes implementing an 'at-the-market' (ATM) facility to provide interim access to capital during market downturns[21]. Corporate Governance and Financial Management - Kazia has launched a new ESG framework to enhance corporate responsibility and sustainability practices[80]. - The company is committed to high standards of corporate governance, respecting frameworks of both ASX and NASDAQ[86]. - The company has no dividends paid, recommended, or declared during the current or previous financial year, indicating a focus on reinvestment into R&D[108]. - The total remuneration for key management personnel (KMP) amounted to AUD 4,264,968 for the financial year ended 30 June 2022[146]. - The company aims to align executive interests with shareholders through equity-based payments that vest in tranches based on tenure[143]. Financial Position and Equity - The enterprise value of the company rose significantly to AUD 145,349,234 in June 2022, compared to AUD 34,751,206 in June 2021, marking a 318% increase[149]. - The number of share options issued to KMP increased to 4,300,000 in 2022 from 2,100,000 in 2021, reflecting a 104.76% increase[149]. - The company issued shares totaling $4,202,222 during the year, with share issue costs amounting to $492,735[183]. - The directors have prepared the financial statements on a going concern basis, contingent on the ability to secure sufficient cash from various sources[194].