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 has announced preliminary results from its Phase 1b trial involving Paxalisib, pembrolizumab, and standard chemotherapy, showing promising outcomes in a patient with metastatic triple-negative breast cancer [1][5][6] Patient Profile - The trial's first patient is a 61-year-old female diagnosed with metastatic triple-negative breast cancer, specifically localized to the left upper lobe of the lung [3] Clinical Significance of Patient Data - Circulating tumor cell (CTC) clusters are critical in metastasis and are associated with poor prognosis; they can resist apoptosis and evade immune detection [4] - The combination treatment of Paxalisib and immunotherapy resulted in a rapid reduction of both CTC numbers and clusters, which is not typically observed with chemotherapy or immunotherapy alone [5][6] Mechanistic Insights - The early data aligns with preclinical findings that suggest Paxalisib disrupts both single CTCs and multicellular clusters, indicating a mechanistic synergy [2][5] Next Steps - The company plans to explore the relationship between CTC kinetics and radiographic responses, continue patient enrollment, and conduct a comprehensive analysis of the immune microenvironment and CTC kinetics [7] - The investigational regimen includes Paxalisib, pembrolizumab, and chemotherapy, with results showing over 50% reduction in total CTC count and a notable decrease in CTC clusters [7] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being Paxalisib, which targets the PI3K/Akt/mTOR pathway for various cancers [9]

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].

Core Insights - Kazia Therapeutics Limited has received a research grant from The Michael J. Fox Foundation for Parkinson's Research to investigate the therapeutic potential of paxalisib for Parkinson's disease [1][2] - The research will be conducted in collaboration with The Hebrew University of Jerusalem, focusing on preclinical studies to establish a link between a specific pathway in Parkinson's disease and paxalisib [2][3] - Paxalisib is a blood-brain barrier-penetrating inhibitor targeting class IA phosphatidylinositol 3-kinase (PI3K), with the aim of addressing the underlying pathophysiology of Parkinson's disease [2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with paxalisib as its lead program [4] - Paxalisib has been involved in ten clinical trials for various brain cancers, including a completed Phase 2/3 study in glioblastoma reported in 2024 [4] - The company has received multiple designations from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [4] Research Objectives - The primary goal of the research is to explore the therapeutic potential of paxalisib in treating Parkinson's disease by inhibiting the AKT phosphorylation reaction of α-SynA53T [3] - Preliminary findings from Professor Ronit's lab suggest a significant role of the PI3K/AKT/mTORC pathway in the pathogenesis of Parkinson's disease [3] - The research will assess the impact of paxalisib on mouse survival, motor and non-motor performances, and various disease biomarkers [2][3]

Core Viewpoint - Kazia Therapeutics Limited has received regulatory approval to launch a clinical trial for the combination of paxalisib and immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer, which is known for its aggressive nature and treatment resistance [1][2][4]. Group 1: Clinical Trial Details - The ABC-Pax study is a multi-centre, open-label phase 1b trial that will enroll 24 patients from leading cancer centers in Queensland, Australia, with treatment lasting up to 12 months [2]. - The trial aims to assess the safety and efficacy of paxalisib in combination with either KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib) [2][3]. - Enrollment for the clinical trial is currently open at the Royal Brisbane and Women's Hospital, with plans to expand to additional sites in Australia [3]. Group 2: Scientific Background - Research led by QIMR Berghofer scientists in collaboration with Kazia Therapeutics has shown that the combination of paxalisib and immunotherapy can trigger a novel molecular program that makes dormant cancer cells visible to the immune system [3]. - The preclinical data presented at the San Antonio Breast Cancer Symposium on December 12, 2024, highlighted potential therapeutic synergies between paxalisib and the checkpoint inhibitor pembrolizumab, as well as with the poly (ADP-ribose) polymerase inhibitor olaparib [3]. Group 3: Company Insights - Kazia Therapeutics is focused on developing paxalisib, an investigational drug targeting the PI3K/Akt/mTOR pathway, which has been involved in ten clinical trials for various brain cancers [7]. - The company has received multiple designations from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [7]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies and has completed a Phase I study [8].

Core Viewpoint - Kazia Therapeutics Limited has successfully closed a registered direct offering and concurrent private placement, raising approximately $2.0 million to support its oncology-focused drug development efforts [1][3]. Group 1: Offering Details - The company issued 1,333,333 American Depositary Shares (ADSs) at a purchase price of $1.50 per ADS, with each ADS representing 100 ordinary shares [1]. - The offering included unregistered warrants to purchase an additional 1,333,333 ADSs, with an exercise price of $1.50 per ADS, immediately exercisable and expiring in five and a half years [1]. - Maxim Group LLC acted as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital, research, clinical development, and administrative expenses [3]. Group 3: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program, paxalisib, targeting multiple forms of brain cancer [7]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [7]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies [7][8].

Core Viewpoint - Kazia Therapeutics Limited has announced a definitive agreement for the purchase and sale of up to 1,333,333 American Depositary Shares (ADSs) at a price of $1.50 per ADS, aiming to raise approximately $2.0 million in gross proceeds for general corporate purposes [1][3]. Group 1: Offering Details - The offering includes a registered direct offering and a concurrent private placement of unregistered warrants to purchase an equal number of ADSs [1][2]. - The warrants will have an exercise price of $1.50 per ADS, will be immediately exercisable, and will expire five and a half years from issuance [1]. - The closing of the offering is expected around January 13, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may encompass working capital, research expenses, clinical development, and administrative costs [3]. Group 3: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being paxalisib, aimed at treating various forms of brain cancer [7]. - Paxalisib has undergone ten clinical trials, with a pivotal study in glioblastoma expected to present data in late 2024 [7]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies [8].