BioVie(BIVI)
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BioVie(BIVI) - 2024 Q3 - Quarterly Report
2024-05-14 21:06
Financial Performance - Total operating expenses for the three months ended March 31, 2024, were approximately $7.7 million, a decrease of approximately $6.1 million compared to $13.8 million for the same period in 2023[243]. - For the nine months ended March 31, 2024, total operating expenses were approximately $27.4 million, down from $34.1 million in 2023, with a decrease in research and development expenses of approximately $4.0 million[247]. - The net loss for the three months ended March 31, 2024, was approximately $8.1 million, a decrease of $6.9 million compared to a net loss of $15.0 million for the same period in 2023[265]. - For the nine months ended March 31, 2024, the net loss was approximately $27.2 million, down $13.9 million from a net loss of $41.1 million for the same period in 2023[268]. Research and Development - Research and development expenses for the three months ended March 31, 2024, were approximately $5.7 million, down from $11.2 million in 2023, primarily due to the completion of clinical trials[244]. - Research and development expenses decreased by approximately $5.5 million for the three months and $4.0 million for the nine months ended March 31, 2024, compared to the same periods in 2023[265][268]. - The company is finalizing protocol designs for a Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis, following guidance from the FDA[241]. - The Phase 2 study of bezisterim for Parkinson's Disease met its primary and secondary objectives, but the initiation of the Phase 3 study is currently on hold pending additional funding[237]. - Bezisterim (NE3107) has been approved as the non-proprietary name for the investigational drug, which targets inflammation-driven insulin resistance and may represent a new approach to treating Alzheimer's and Parkinson's diseases[256]. Expenses and Costs - Selling, general and administrative expenses decreased to approximately $2.0 million for the three months ended March 31, 2024, from $2.5 million in 2023, reflecting a decline in investor relations and legal expenses[245]. - Selling, general and administrative expenses decreased by approximately $546,000 for the three months and $2.8 million for the nine months ended March 31, 2024, compared to the same periods in 2023[265][268]. Funding and Capital - As of March 31, 2024, the company had working capital of approximately $18.1 million and cash and cash equivalents totaling approximately $30.4 million[251]. - The company closed a public offering on March 6, 2024, raising approximately $21.0 million before expenses, by offering 15,000,000 shares of common stock[252]. - The company sold approximately 3.3 million shares of its Common Stock, generating total net proceeds of approximately $9.3 million after commissions and offering costs[271]. - The company has not generated any revenue and does not expect to do so in the foreseeable future, relying on ongoing development and commercialization efforts for future operations[272]. - Management anticipates future funding sources may include equity sales, loans, or other strategic transactions[272]. Other Income - The company reported a net increase in other income of approximately $7.2 million for the nine months ended March 31, 2024, primarily driven by a change in fair value of derivative liabilities[250]. - The change in the fair value of derivative liabilities contributed approximately $475,000 for the three months and $6.0 million for the nine months ended March 31, 2024[265][268].
BioVie secures $13.1M funding from US Department of Defense for Long COVID treatment
Proactive Investors· 2024-04-29 14:12
About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...
BioVie Awarded up to $13.1 Million in Funding from U.S. Department of Defense to Evaluate Bezisterim (NE3107) for the Treatment of Long COVID
Newsfilter· 2024-04-29 12:00
Increasing evidence supports a role for viral persistence, chronic inflammation and immune and metabolic dysregulation in driving long COVID Bezisterim, an anti-inflammatory and insulin-sensitizer that permeates the blood brain barrier, could represent a novel oral treatment targeting an underlying cause of long COVID symptoms CARSON CITY, Nev., April 29, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the tr ...
BioVie presents new data showing lead drug asset may promote healthier aging
Proactive Investors· 2024-04-25 13:26
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
BioVie Presents Data Showing Potential for Bezisterim (NE3107) to Reduce Inflammation and Restore Homeostasis in a Manner Correlated with Alzheimer's Disease and Biomarker Endpoints
Newsfilter· 2024-04-25 12:00
"Bezisterim" has been approved as the non-proprietary name for NE3107Data shows how bezisterim may be restoring homeostasis via specific genes associated with dementia, metabolism, and inflammation CARSON CITY, Nev., April 25, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease, today announced that an or ...
BioVie to Present Data Showing How NE3107 Potentially Restores Homeostasis via Specific Genes Associated with Dementia, Metabolism, and Inflammation
Newsfilter· 2024-04-18 12:00
CARSON CITY, Nev., April 18, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that an oral presentation and poster presentation will be shared at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit to be held in Boston, Massachusetts April 23-25. Additionally, the United States Adopted Names ( ...
Bears are Losing Control Over BioVie Inc. (BIVI), Here's Why It's a 'Buy' Now
Zacks Investment Research· 2024-03-12 14:55
The price trend for BioVie Inc. (BIVI) has been bearish lately and the stock has lost 34.8% over the past week. However, the formation of a hammer chart pattern in its last trading session indicates that the stock could witness a trend reversal soon, as bulls might have gained significant control over the price to help it find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts ...
BioVie to kick off Phase 2b trial for lead asset in Parkinson's disease in late-summer
Proactive Investors· 2024-03-11 12:56
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
BioVie Announces Pipeline Update and Near-Term Clinical Priorities
Newsfilter· 2024-03-11 12:00
Recently completed financing provides sufficient funds for near-term Parkinson's Disease priority Plans for Phase 2b trial of NE3107 as first-line monotherapy for Parkinson's Disease being finalized with targeted launch late-summer 2024 Once-daily NE3107 formulation expected to be available early 2025 and will be used for Phase 3 trial in Alzheimer's Disease Phase 3 trial for BIV201 in preparation following FDA feedback with guidance on development path; program delayed pending partnership funding CARSON CI ...
BioVie Inc. Announces Closing of Public Offering
Newsfilter· 2024-03-06 22:00
CARSON CITY, Nev., March 06, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders, today announced the closing of its previously announced best efforts public offering of 15,000,000 shares of its common stock, pre-funded warrants to purchase 6,000,000 shares of its common stock ("Pre-funded Warrants")and w ...