Group 1 - Kazia Therapeutics Limited has entered into a securities purchase agreement for a private placement of equity securities, raising approximately $2.0 million [1][2] - The securities in the PIPE are priced at a 5% premium to the closing price of Kazia's ADSs on July 31, 2025, and the transaction is expected to close on August 4, 2025 [1][2] - The net proceeds from the PIPE will be used to support the clinical development of lead programs, including paxalisib and EVT801, as well as for general corporate purposes [2][3] Group 2 - The CEO of Kazia Therapeutics expressed gratitude for investor support and highlighted the importance of the additional capital for advancing clinical-stage assets [3] - The securities sold in this PIPE are not registered under the Securities Act of 1933 and will require a shelf registration statement to be filed with the SEC within 60 days of closing [3][4] - Kazia Therapeutics is focused on developing innovative oncology treatments, with lead programs targeting brain cancer and advanced solid tumors [6]

Core Insights - Kazia Therapeutics Limited announced transformative preclinical research on paxalisib, highlighting its potential in treating triple-negative breast cancer (TNBC) [1][2] - The research indicates paxalisib can reprogram the tumor microenvironment and enhance immune response, showing synergy with immune checkpoint inhibitors [2][6] - The publication of this research supports the ongoing Phase 1b clinical trial of paxalisib in advanced breast cancer [4] Preclinical Research Findings - Conducted by Professor Sudha Rao at QIMR Berghofer Medical Research Institute, the study shows paxalisib's ability to remodel the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation [2][6] - The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated significant antitumor activity, leading to robust tumor regression and prolonged survival in preclinical models [6] Clinical Development - Kazia has initiated a Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, marking a significant step in clinical translation [5] - The company has previously conducted ten clinical trials for paxalisib, primarily focused on brain cancers, and is now expanding its application to solid tumors [5] Regulatory Designations - Paxalisib has received multiple designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions, indicating its potential therapeutic value [5] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, a PI3K/Akt/mTOR pathway inhibitor [5]

Core Insights - Kazia Therapeutics has initiated a Phase 1b clinical trial for paxalisib, targeting advanced breast cancer, marking a significant step in expanding its application beyond brain cancer [1][3] - The trial will evaluate paxalisib in combination with established therapies like olaparib and pembrolizumab, focusing on safety, tolerability, and preliminary efficacy [2][6] Study Design - The trial is a multi-center, open-label, randomized study with two treatment arms: Arm A will assess paxalisib with olaparib, while Arm B will combine paxalisib with pembrolizumab and standard chemotherapy [2][6] - Participants will undergo deep biomarker profiling to support future development and assess early clinical activity signals [2] Strategic Significance - The integration of paxalisib into combination regimens is part of Kazia's strategy to enhance value through differentiated science and collaborations [5] - The trial aims to provide insights into how paxalisib may enhance the effectiveness of immune checkpoint inhibitors and DNA repair-targeted therapies [6] Company Background - Kazia Therapeutics is an oncology-focused biotechnology company based in Sydney, Australia, with a lead program centered on paxalisib, a dual PI3K/mTOR inhibitor [5][7] - The company has previously conducted multiple clinical trials for paxalisib, including studies in glioblastoma and other brain cancers, with several trials showing promising interim data [7]

Core Insights - Kazia Therapeutics Limited has made significant advancements in its clinical programs and corporate strategy, particularly with its lead drug paxalisib, which is being evaluated for multiple cancer types [2][3] Pipeline - Paxalisib - The company received a research grant from The Michael J. Fox Foundation to explore paxalisib's potential as a treatment for Parkinson's disease, funding preclinical studies at The Hebrew University of Jerusalem [4] - A clinical trial has been launched to evaluate the combination of paxalisib with immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer [4] - Kazia has aligned with the FDA on the design of a pivotal phase 3 study for paxalisib in glioblastoma, which will enroll approximately 366 patients and compare paxalisib to standard of care [8] Pipeline - EVT801 - The last patient follow-up in a Phase 1 study of EVT801 for advanced solid tumors was completed, with final data expected in Q2 2025 [6] Corporate Developments - Kazia raised $3 million in capital during Q1 2025, including $1 million in non-dilutive funding [2][3] - The company received a notification from Nasdaq regarding its Market Value of Listed Securities falling below $35 million, with a compliance period until November 10, 2025 [9] - Kazia executed a reverse ADS split to maintain compliance with Nasdaq's minimum bid price requirement [9] - The company sold all intellectual property rights to Cantrixil for $1 million, as Vivesto decided not to pursue its development in ovarian cancer [9] - CEO Dr. John Friend purchased 8,000 ADSs at a split-adjusted price of $4.2465 per ADS [9]

Core Viewpoint - Kazia Therapeutics Limited has sold all intellectual property and trademark rights to its oncology drug candidate Cantrixil to Vivesto for USD $1 million, providing non-dilutive funding to advance its clinical-stage pipeline [1][3]. Group 1: Transaction Details - Kazia will receive USD $1 million from Vivesto for the rights to Cantrixil [1]. - Vivesto had previously licensed exclusive global development and commercialization rights for Cantrixil from Kazia in March 2021 [2]. - Vivesto has decided not to pursue Cantrixil for ovarian cancer and is now exploring it for hematological cancers [2]. Group 2: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program, paxalisib, targeting multiple forms of brain cancer [4]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma [4]. - The company is also developing EVT801, a small molecule inhibitor of VEGFR3, which has shown activity against a broad range of tumor types [4].