Pipeline Expansion - Enochian Biosciences has expanded its pipeline from a single potential cure for HIV to four additional potential cures, including treatments for Hepatitis B Virus (HBV) and various solid tumors [113]. - The company is developing ENOB-HV-01, a novel gene-modified T cell therapy aimed at significantly increasing engraftment and avoiding the need for chemotherapy, with a Pre-IND submission expected soon [127]. - Enochian has an exclusive license for a potential inhaled treatment for SARS-CoV-1 and -2, with promising in vitro and in vivo results presented at a major conference [120][121]. - Enochian's innovative approach to HBV aims to induce the death of liver cells infected with the virus, with a Pre-IND process completed and potential for clinical trials to begin by the end of 2022 or in 2023 [133][137]. - The company is targeting pancreatic cancer, triple-negative breast cancer, glioblastoma, and renal cell carcinoma with a new therapeutic vaccination platform, with initial results expected in the first half of 2022 [138][139]. - Enochian is in the development phase of additional product candidates related to its HIV pipeline, including ENOB-HV-31 and ENOB-HV-32 [130]. Financial Performance - Enochian has never generated sales revenue and expects this to continue until its therapies are approved for marketing in the U.S. and/or Europe [140]. - Operating expenses for the three months ended December 31, 2021, were $6,330,791, an increase of $3,025,575 or approximately 92% compared to the same period in 2020 [148]. - General and administrative expenses for the three months ended December 31, 2021, were $4,154,901, representing an increase of $2,214,914 or approximately 114% compared to the same period in 2020 [150]. - Research and development expenses for the six months ended December 31, 2021, were $5,150,328, an increase of $2,765,484 or approximately 116% compared to the same period in 2020 [153]. - Net loss for the three months ended December 31, 2021, was $6,582,941, an increase of $3,649,645 or approximately 124% compared to the same period in 2020 [156]. - Total assets as of December 31, 2021, were $183,136,138, a decrease from $189,605,225 as of June 30, 2021 [162]. - Total liabilities as of December 31, 2021, were $17,516,675, an increase from $14,942,286 as of June 30, 2021 [163]. - Cash used in operating activities for the six months ended December 31, 2021, was $(9,897,151), compared to $(5,251,828) for the same period in 2020 [165]. - Cash provided by financing activities for the six months ended December 31, 2021, was $2,950,741, compared to cash used of $(40,408) during the same period in 2020 [166]. - The company had $13,707,907 in cash as of December 31, 2021, a decrease of 34% compared to $20,664,410 as of June 30, 2021 [161]. - The company does not anticipate earning any revenues until its therapies or products are approved for marketing and sale [147]. Research and Development Challenges - The COVID-19 pandemic has caused delays in research activities but has not materially affected operations; however, it has increased costs for conducting animal studies [142][144]. - The company has established an HBV Scientific Advisory Board to guide its research and development efforts in HBV treatment and cure [134].
Renovaro Biosciences (RENB) - 2022 Q2 - Quarterly Report