BioVie(US:BIVI)2024-02-12 16:00Operating Expenses - Total operating expenses for the three months ended December 31, 2023, were approximately $8.8 million, a decrease of $2.7 million compared to $11.5 million for the same period in 2022[11] - Total operating expenses for the six months ended December 31, 2023, were approximately $19.7 million, a slight decrease from $20.3 million for the same period in 2022[13] Research and Development - Research and development expenses decreased by approximately $563,000 due to the completion of clinical trials, while selling, general and administrative expenses decreased by approximately $2.2 million, primarily from a decline in stock compensation expense[11] - The company received FDA guidance for the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis in June 2023[9] - BIV201 has been granted both FDA Fast Track designation and Orphan Drug status, indicating its potential significance in treating liver disease[8] - The company is finalizing protocol designs for the Phase 3 study of BIV201, which is administered as a patent-pending liquid formulation[9] Financial Position - As of December 31, 2023, the company had working capital of approximately $6.6 million and cash and cash equivalents totaling approximately $20.2 million[16] - The company reported an accumulated deficit of approximately $320.3 million as of December 31, 2023[16] - Management expressed uncertainty regarding the ability to obtain sufficient financing to fund continuing operations, raising substantial doubt about the company's ability to continue as a going concern[17] Other Income - Other income for the three months ended December 31, 2023, was approximately $380,000, compared to a net expense of $4.2 million for the same period in 2022, resulting in a net increase of approximately $4.6 million[12]