Renovaro Biosciences (RENB) - 2025 Q2 - Quarterly Report

Company Focus and Strategy - Renovaro Inc. has shifted its primary focus to the development of Renovaro Cube technologies following the acquisition of GEDi Cube Intl Ltd. on February 13, 2024[122][123]. - Renovaro Biosciences aims to develop advanced allogeneic cell and gene therapies for long-term cancer remission and treatment of serious infectious diseases, contingent on obtaining necessary funding[123][124]. - The company is actively pursuing partnerships with leading academic cancer centers and pathology centers to enhance multi-omic and multi-modal capacity[157]. - The company intends to commercialize products and test kits for healthcare providers to expedite cancer diagnosis and treatment selection[160]. - The company has streamlined its organization to focus on the development and validation of its AI-driven cancer diagnostics platform[172]. Technology and Product Development - The allogeneic cell therapy platform has completed the pre-IND and IND-enabling phase, focusing on genetically modified dendritic cell therapeutic vaccines for solid tumors[128]. - Renovaro Cube's proprietary AI platform utilizes a multi-omics approach to enhance early cancer detection and diagnosis, targeting biomarkers even in asymptomatic patients[133][134]. - The company is developing multi-cancer early detection (MCED) blood tests to identify abnormal genetic patterns indicative of cancer, potentially improving early detection rates[138]. - Renovaro Cube plans to expand its diagnostic tests and test kits for non-invasive liquid biopsy samples across Europe and the United States[141]. - The AI technology developed by Renovaro Cube aims to enhance the accuracy and sensitivity of early cancer detection, facilitating earlier intervention and improved patient outcomes[142]. - Renovaro Cube's product development strategy includes a focus on recurrence detection, treatment response prediction, and support for clinical trials through patient cohort selection[139]. - The company intends to leverage multi-modal data analysis to provide insights into disease characterization and improve diagnostic accuracy[140]. - The AI platform includes Explainable AI features, ensuring transparency and traceability in its diagnostic processes[165]. - Renovaro Cube's AI technology aims to provide non-invasive alternatives for complex cancer detection procedures, focusing on multi-omics data[27]. Financial Performance and Position - The company incurred a net loss of $7,252,394 and$51,464,429 for the three and six months ended December 31, 2024, respectively[171]. - As of December 31, 2024, the company had cash and cash equivalents of $311,764 and an accumulated deficit of$383,919,510[171]. - Operating expenses for the three months ended December 31, 2024, were $4,546,316, an increase of 6$4,270,075 in 2023[178]. - General and administrative expenses for the three months ended December 31, 2024, were $4,353,123, reflecting a 20$3,616,392 in 2023[180]. - Research and development expenses for the three months ended December 31, 2024, decreased by 74% to $161,084 from$620,521 in 2023[182]. - The net loss for the three months ended December 31, 2024, was $7,252,394, representing a 60$4,529,121 in 2023[186]. - Total assets decreased to $111,340,272 as of December 31, 2024, from$163,129,450 as of June 30, 2024, primarily due to goodwill impairment of $47,614,729[191]. - The company had a working capital deficit of$26,898,493 as of December 31, 2024, compared to $28,312,274 as of June 30, 2024, a decrease of 5$4,576,052, a decrease from $5,923,830 in 2023[192]. - The company recorded other income of$6,420,440 for the six months ended December 31, 2024, compared to other expense of $549,960 in 2023, a change of 1,267$311,764 in cash, an increase from $220,467 as of June 30, 2024[190]. Future Outlook and Challenges - The company is dependent on additional financing to fund operations, raising substantial doubt about its ability to continue as a going concern[171]. - The company aims to validate its biomarker panels through collaboration with clinical partners in real-world settings[155]. - The company plans to hire additional staff to accelerate the development of its AI platform and infrastructure[158].